risk management recruitment - clinical research news online · real-time visibility into operations...

Adaptive Trials .................................................................................. 3

Clinical Genomics.............................................................................. 3

Clinical Informatics ........................................................................... 4

Clinical Research............................................................................... 5

Clinical Sequencing........................................................................... 5

Clinical Trial Design .......................................................................... 5

Clinical Trials ..................................................................................... 7

Cloud Computing ............................................................................... 7

Consulting ......................................................................................... 8

CRO.................................................................................................... 8

CTMS................................................................................................. 9

Data Analytics ................................................................................. 10

Data Collection................................................................................ 11

Data Monitoring .............................................................................. 12

EDC .................................................................................................. 12

Imaging............................................................................................ 13

Lab Supplies/Services..................................................................... 15

Market Data .................................................................................... 15

Market Research/Surveys............................................................... 16

Medical Devices.............................................................................. 16

Medical Writing .............................................................................. 16

Mobile Technologies ....................................................................... 17

New Drug Application..................................................................... 17

Outsourcing ..................................................................................... 17

Patient Recruitment ........................................................................ 18

Phase I ............................................................................................. 18

Preclinical ........................................................................................ 18

Project Management....................................................................... 19

Quality Risk Management............................................................... 20

Risk Management ........................................................................... 20

Software.......................................................................................... 21

Training ............................................................................................ 22

Translational Research .................................................................... 22

CLINICAL RECRUITMENT

Clin

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Tr

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Des

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Clinical Trials

CON

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SEAR

CH

ORGA

NIZ

ATIO

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Clinical Trial Management Systems

Regulatory

Regulatory

Site Selection

TRIA

L M

ASTE

R FI

LERI

SK M

ANAG

EMEN

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Software

Trai

ning

DATA ANALYTICS

DATA COLLECTION

Electronic Data CaptureElectronic Data

HealthIT

IMAGIN

G

Lab

Supp

lies

& Se

rvic

es Patient Recruitment

ecruitment

Patient Reported Outcomes

PHASE IPHASE IIPHASE IIIPHASE IV

Preclinical

Product Directory

Produced by

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ContentsAdaptive Trials .................................................................................. 3






Clinical Trials ..................................................................................... 7

Cloud Computing ............................................................................... 7

Consulting ......................................................................................... 8

CRO.................................................................................................... 8

CTMS................................................................................................. 9

Data Analytics ................................................................................. 10

Data Collection................................................................................ 11

Data Monitoring .............................................................................. 12

EDC .................................................................................................. 12

Imaging............................................................................................ 13


Market Data .................................................................................... 15


Medical Devices.............................................................................. 16

Medical Writing .............................................................................. 16



Outsourcing ..................................................................................... 17


Phase I ............................................................................................. 18

Preclinical ........................................................................................ 18



Risk Management ........................................................................... 20

Software.......................................................................................... 21

Training ............................................................................................ 22


Clinical Informatics News reports on innovative technologies from clinical trials to medical informatics. Technology continues to permeate all aspects of clinical trials and the patient experience, and the tools to support these efforts are maturing rapidly. ClinicalInformaticsNews.com and the Clinical Informatics News email newsletters provide authoritative news, views, and insights on the vast landscape of innovation between clinical trial management and delivery of care.

For more information on our products and to subscribe, visit ClinicalInformaticsNews.com.

About Clinical Informatics News











Clinical Trials ..................................................................................... 7

Cloud Computing ............................................................................... 7

Consulting ......................................................................................... 8

CRO.................................................................................................... 8

CTMS................................................................................................. 9

Data Analytics ................................................................................. 10

Data Collection................................................................................ 11

Data Monitoring .............................................................................. 12

EDC .................................................................................................. 12

Imaging............................................................................................ 13


Market Data .................................................................................... 15


Medical Devices.............................................................................. 16

Medical Writing .............................................................................. 16



Outsourcing ..................................................................................... 17


Phase I ............................................................................................. 18

Preclinical ........................................................................................ 18



Risk Management ........................................................................... 20

Software.......................................................................................... 21

Training ............................................................................................ 22


Adaptive TrialsBalance

Medidata Solutions

350 Hudson St., Fl 9New York, NY 10014(212) 918-1800www.mdsol.com

Medidata Balance heralds a new generation of cloud-based Interactive Response Technology (IRT) capabilities. • New user paradigm based on a simple, highly-configurable

interface • Unified with electronic data capture (EDC) system Medidata

Rave® or as a build by Medidata, CRO or sponsor• Superior and agile technology with streamlined design and

real-time visibility into operations

Clinical GenomicsCofactor FFPExact

Cofactor Genomics

4044 Clayton Ave.St. Louis, MO 63110(314) 531-4647www.cofactorgenomics.com

Low-quality RNA-seq. With the vast majority of patient samples and clinical archives stored as formalin-fixed and paraffin embedded (FFPE) tissue blocks, a reliable solution for chemically-modified and fragmented RNA from FFPE is required. For samples with >250 ng of RNA, our FFPExact pipeline first evaluates RNA fragmentation via DV200 analysis, then applies standardized library preparation protocols to guarantee reproducible, interpretable results from these valuable samples. FFPExact delivers: 1) Non-biased analysis of fragmented RNA 2) Minimization of reads lost to ribosomal content 3) Access to valuable clinical archives and patient samples.

Cofactor Paragon

Cofactor Genomics


Paragon: Profiling micro-environment cell report for Immuno-oncology. Cofactor Paragon reports on the cellular components of the tumor micro-environment. 32 cell types are reported and provide valuable insight in studies aimed at understanding how the micro-environment and the immune activity plays a key role in efficacy of treatment.

Cofactor Pinnacle

Cofactor Genomics


Pinnacle: The RNA-based biomarker panel for cancer. Cofactor Pinnacle enables the identification of important cancer associated features, not detectable by DNA sequencing alone. Pinnacle measures the RNA expression of 318 prominent cancer genes, identifies those with oncogenic expression, and enables fusion identification in 283 critical cancer associated genes from any type of formalin-fixed or fresh frozen solid tumor in a CAP-CLIA certified lab.

Cofactor TotalRNA

Cofactor Genomics


RNA-seq analysis of non-coding species enabled by depletion of ribosomal species. Allows for the analysis of lncRNA and non-polyadenylated species. More forgiving molecular approach able to accommodate some sample degradation. Access the breadth of your sample’s transcriptome. Ideal for model organisms (human, mouse, and rat).

All projects include our molecular quality control checkpoints at each stage in the molecular workflow, and full comparative expression analysis delivered via the ActiveSite interface. For research use only.


http://www.mdsol.com

http://www.cofactorgenomics.com











Clinical Trials ..................................................................................... 7

Cloud Computing ............................................................................... 7

Consulting ......................................................................................... 8

CRO.................................................................................................... 8

CTMS................................................................................................. 9

Data Analytics ................................................................................. 10

Data Collection................................................................................ 11

Data Monitoring .............................................................................. 12

EDC .................................................................................................. 12

Imaging............................................................................................ 13


Market Data .................................................................................... 15


Medical Devices.............................................................................. 16

Medical Writing .............................................................................. 16



Outsourcing ..................................................................................... 17


Phase I ............................................................................................. 18

Preclinical ........................................................................................ 18



Risk Management ........................................................................... 20

Software.......................................................................................... 21

Training ............................................................................................ 22


miRNAble

Cofactor Genomics


Small RNA-seq. Enrichment of small RNA molecules including miRNA, snoRNA, and more. Economical read depth (10 million reads) ensures high coverage of desired molecules. Annotation using comprehensive database and comparative expression analysis. Cofactor’s small RNA characterization is optimized for total RNA samples, which streamlines sample delivery for you.

ONCOREF MAPK Mutation Panel Reference Standards

Applied StemCell, Inc.

521 Cottonwood Drive, Suite 111Milpitas, CA 95035(408) 773-8007www.appliedstemcell.com

Applied StemCell is a California-based biotech company that is employing the most advanced genome editing technologies for the generation of molecular reference standards. Our existing, ONCOREF™ product series, features the largest MAPK mutation panel currently on the market. In addition to off-the-shelf products, we offer custom services and collaborative efforts to help advance the next generation of molecular reference standards.

Clinical InformaticsBioinformatics Services

Systems Imagination

7730 E. Greenway, Suite 205Scottsdale, AZ 85260(480) 422-2731www.systemsimagination.com

Systems Imagination offers tech-enabled services to accelerate the discovery and evolution of scientific knowledge. SII’s Big Data to Knowledge Solution uses a proprietary knowledge computing platform and expert analytical services by world-class team of experts, enabling clients to translate Big Data into useful scientific knowledge with unprecedented speed and precision.

Microbiome Discovery Service

Second Genome Solutions

341 Allerton AvenueSouth San Francisco, CA 94080(650) 489-7871www.secondgenome.com/solutions/

Second Genome Solutions offers an end-to-end Microbiome Discovery Service allowing you to go from Sample to Smarter. Each project is customized to your specific study and includes sample collection logistics, nucleic acid isolation, raw data generation, bioinformatics, and data interpretation.

Second Genome has developed an industry leading Microbial Profiling platform built on proprietary databases that has been used on over 400 projects and processed over 75,000 samples.

SeqsLab

Atgenomix

Rm. 918, 9F, 96, Chia Hsin Bldg. (Second Bldg.) Sec. 2, Zhongshan N. Rd., Zhongshan Dist.Taipei, Taiwan0-98-608-9616www.atgenomix.com

Enterprise-grade analysis platform for your NGS whole genome and exome best practices powered by Apache Spark/Hadoop: 10X FASTQ, BAM to VCF acceleration; 50% Lower computing cost; 4hrs BWA/GATK workflow turnaround.

XIFIN ProNet

XIFIN

12225 El Camino Real San Diego, CA 92130(858) 436-2995www.xifin.com

XIFIN ProNet: Physician Collaboration and Clinical Data Management

Collaborate and communicate across departments, disciplines, and organizations in a cloud-based exchange of diagnostic images, clinical data, and other patient encounter information. XIFIN ProNet enables consolidated storage, sharing, and usage of clinical and financial images and information with a web-based enterprise class data repository and integrated workflows.



http://www.appliedstemcell.com

http://www.systemsimagination.com

http://www.secondgenome.com/solutions/

https://www.atgenomix.com

https://www.xifin.com








Clinical Trials ..................................................................................... 7

Cloud Computing ............................................................................... 7

Consulting ......................................................................................... 8

CRO.................................................................................................... 8

CTMS................................................................................................. 9

Data Analytics ................................................................................. 10

Data Collection................................................................................ 11

Data Monitoring .............................................................................. 12

EDC .................................................................................................. 12

Imaging............................................................................................ 13


Market Data .................................................................................... 15


Medical Devices.............................................................................. 16

Medical Writing .............................................................................. 16



Outsourcing ..................................................................................... 17


Phase I ............................................................................................. 18

Preclinical ........................................................................................ 18



Risk Management ........................................................................... 20

Software.......................................................................................... 21

Training ............................................................................................ 22


Clinical ResearchCloudbyz CTMS

Cloudbyz

4320 Winfield Road, Suite 200Warrenville, IL 60555(312) 763-8040www.cloudbyz.com

Integrated clinical trial management suite on Salesforce.com cloud.

On-site Monitoring

Medidata Solutions

350 Hudson St., Floor 9New York, NY 10013(212) 918-1800www.mdsol.com

A monitoring solution wouldn’t be complete without the tools that clinical research associates (CRAs) need to efficiently manage site monitoring activities & create visit reports. Medidata’s cloud-based on-site monitoring module is integrated with EDC to save CRAs time & improve the quality of data and documents. Get more value with Medidata’s on-site monitoring technology• Improve CRA productivity• Enhance data & document quality• Reduce integration complexity

PDOX® Pre-Clinical Research Services

AntiCancer PDOX, Inc.

7917 Ostrow St. San Diego, CA 92111(858) 654-2555anticancerpdox.com

The PDOX technique is the most clinically accurate mouse cancer model, especially with regard to metastasis and drug sensitivity. Using GFP imaging, primary tumor growth and metastases can be tracked in real-time. Effective drugs can be rapidly discovered and evaluated in PDOX models utilizing human tumor cell lines and patient tumors. We provide customized contract services for in vivo drug evaluation, including developing cancer models and design of individual protocols.

Clinical SequencingCofactor mRNAbleCofactor Genomics4044 Clayton Ave.St. Louis, MO 63110(314) 531-4647www.cofactorgenomics.com

RNA-seq poly(A) enrichment of mRNA species in your samples. Focus your sequencing reads on coding regions of the transcriptome with 30- or 60-million reads, guaranteed, with 3 week turnaround. Make the most of your analysis with transcript annotation. Excellent approach for non-model and model organisms, alike.


SeqsLab

Atgenomix


Enterprise-grade analysis platform for your NGS whole genome and exome best practices powered by Apache Spark/Hadoop: 10X FASTQ, BAM to VCF acceleration; 50% Lower computing cost; 4hrs BWA/GATK workflow turnaround

Clinical Trial DesignBalance

Medidata Solutions


Medidata Balance heralds a new generation of cloud-based Interactive Response Technology (IRT) capabilities. • New user paradigm based on a simple, highly-configurable interface • Unified with electronic data capture (EDC) system Medidata

Rave® or as a build by Medidata, CRO or sponsor• Superior and agile technology with streamlined design and real-

time visibility into operations


http://www.cloudbyz.com

http://Salesforce.com


http://anticancerpdox.com











Clinical Trials ..................................................................................... 7

Cloud Computing ............................................................................... 7

Consulting ......................................................................................... 8

CRO.................................................................................................... 8

CTMS................................................................................................. 9

Data Analytics ................................................................................. 10

Data Collection................................................................................ 11

Data Monitoring .............................................................................. 12

EDC .................................................................................................. 12

Imaging............................................................................................ 13


Market Data .................................................................................... 15


Medical Devices.............................................................................. 16

Medical Writing .............................................................................. 16



Outsourcing ..................................................................................... 17


Phase I ............................................................................................. 18

Preclinical ........................................................................................ 18



Risk Management ........................................................................... 20

Software.......................................................................................... 21

Training ............................................................................................ 22


Clinical Trial Management System (CTMS)

Medidata Solutions


Your clinical trial management system (CTMS) should adapt to you, not vice versa. That’s why Medidata CTMS was created in the cloud more than 10 years ago—with powerful modules for outsourcing, site monitoring and site payments you can turn on together or separately as needed.

Grants manager

Medidata Solutions


Medidata Grants Manager transforms site budgeting & negotiation, allowing sponsors & CROs to• Reduce investigator site costs. Only Grants Manager uses the

industry’s largest database of negotiated procedure costs to protect you from overpayments

• Develop and negotiate budgets. Grants Manager fast tracks budgeting by giving all parties access to industry benchmarks & electronic negotiation

• Minimize compliance risk. Budgets are more accurate, resulting in less underfunded studies

Insights

Medidata Solutions


Medidata Insights is the turnkey clinical analytics solution providing advanced metrics, visualizations & the most powerful set of industry data & benchmarks. With Medidata Insights, you can• Cut operational costs with operational data visualizations that

let you deploy resources more efficiently. • Reduce cycle times, enabling process improvements so you hit

study milestones.• Mitigate operational risk by comparing your performance to

industry best practice.

RaveX

Medidata Solutions


The industry’s leading unified EDC and CDMS solution

Medidata Rave is the world’s leading solution for capturing, managing and reporting patient data, including unified EDC, CDMS and lab administration features. Rave is the cornerstone of the Medidata Clinical Cloud and allows you to seamlessly add Medidata’s randomization, trial supply, medical coding, safety reporting and mobile health capabilities as your organizational needs grow.

Risk-Based Monitoring

Medidata Solutions


Can a risk-based monitoring (RBM) solution go beyond saving money and actually improve data quality & accelerate treatments to market? Medidata says, “Yes!” Medidata empowers biopharmaceutical companies and CROs to plan, execute, analyze and adjust their studies using a closed-loop adaptive process. With Medidata RBM you can:• Receive immediate benefit • Work seamlessly with Medidata Clinical Cloud® • Achieve deep sustainable value

Study Design Optimization

Medidata Solutions


Medidata’s Study Design Optimization Service optimizes your study design for a better operational execution. By leveraging a best practice approach to study review, organizational impact & a metrics-driven realization of value, Study Design Optimization helps maximize your organization’s adoption of better study design methodologies. This service enters a sponsor’s design detail into the application, delivers documented opportunities and recommendations, and provides sponsor access.















Clinical Trials ..................................................................................... 7

Cloud Computing ............................................................................... 7

Consulting ......................................................................................... 8

CRO.................................................................................................... 8

CTMS................................................................................................. 9

Data Analytics ................................................................................. 10

Data Collection................................................................................ 11

Data Monitoring .............................................................................. 12

EDC .................................................................................................. 12

Imaging............................................................................................ 13


Market Data .................................................................................... 15


Medical Devices.............................................................................. 16

Medical Writing .............................................................................. 16



Outsourcing ..................................................................................... 17


Phase I ............................................................................................. 18

Preclinical ........................................................................................ 18



Risk Management ........................................................................... 20

Software.......................................................................................... 21

Training ............................................................................................ 22


Targeted Sourced Document Verification (TSDV)

Medidata Solutions


Medidata TSDV (targeted source document verification) is a unified, electronic data capture (EDC)-based tool that allows life science companies to efficiently and compliantly reduce the amount of SDV conducted. Its configurable, statistical algorithm lets you control your level of SDV coverage—without sacrificing regulatory compliance or your data quality strategies.

Clinical TrialsCentralized Statistical Analytics (CSA)

Medidata Solutions


Enabling more insightful clinical trial reviews, Medidata Centralized Statistical Analytics (CSA) provides immediate insight into clinical trial site performance and data quality. An integral part of the Medidata Clinical Cloud, CSA integrates data from different systems and provides a comprehensive report for each subject, making it easier to detect and track critical data changes throughout trial execution.


Medidata Solutions



Cloud ComputingPatient Cloud

Medidata Solutions


Medidata Patient Cloud® is a comprehensive and regulatory compliant mobile health (mHealth) solution that accelerates patient-centric clinical research. Patient Cloud enables sponsors to use sensors and apps that capture a richer, more complete dataset directly from the patient, improving the clinical trial experience on the Medidata Clinical Cloud.

XIFIN ProNet

XIFIN




XIFIN RPM

XIFIN


XIFIN RPM (Revenue Performance Management) give laboratories the ability to take control of their billing operations and financial performance. Maximize your financial performance with a technology platform and optimized business processes. Gain control and visibility over reimbursement and AR, with auditable, GAAP & SOX-compliant, scalable solution.















Clinical Trials ..................................................................................... 7

Cloud Computing ............................................................................... 7

Consulting ......................................................................................... 8

CRO.................................................................................................... 8

CTMS................................................................................................. 9

Data Analytics ................................................................................. 10

Data Collection................................................................................ 11

Data Monitoring .............................................................................. 12

EDC .................................................................................................. 12

Imaging............................................................................................ 13


Market Data .................................................................................... 15


Medical Devices.............................................................................. 16

Medical Writing .............................................................................. 16



Outsourcing ..................................................................................... 17


Phase I ............................................................................................. 18

Preclinical ........................................................................................ 18



Risk Management ........................................................................... 20

Software.......................................................................................... 21

Training ............................................................................................ 22


ConsultingBioinformatics Services

Systems Imagination



USB3 Vision Processing Unit

Active Silicon

479 Jumpers Hole Road, Suite 301Severna Park,MD 21146(410) 696-7642www.activesilicon.com

Active Silicon is a leading manufacturer of embedded systems, machine vision products and imaging solutions. As well as offering a range of video interface cards for PCs and embedded form-factors, Active Silicon specialises in developing and manufacturing complete embedded systems. Our latest embedded vision product, the Vision Processing Unit (VPU), is a medical vision computer, designed to acquire image data from USB3 VisionTM cameras. It processes the image stream in real-time and provides several options for data output, including 3G-SDI.

The USB3 Vision Processing Unit has been developed for medical and industrial applications, typically embedded into an OEM machine. The unit has four inputs for USB3 Vision cameras and four 3G-SDI outputs arranged as two channels of 3G-SDI video, each with a duplicate output. It satisfies various medical and quality standards and is designed for long-term use in an environment where high reliability and ease of use are paramount.

CROCofactor FFPExact

Cofactor Genomics



Cofactor mRNAble

Cofactor Genomics




Cofactor Paragon

Cofactor Genomics





http://www.activesilicon.com











Clinical Trials ..................................................................................... 7

Cloud Computing ............................................................................... 7

Consulting ......................................................................................... 8

CRO.................................................................................................... 8

CTMS................................................................................................. 9

Data Analytics ................................................................................. 10

Data Collection................................................................................ 11

Data Monitoring .............................................................................. 12

EDC .................................................................................................. 12

Imaging............................................................................................ 13


Market Data .................................................................................... 15


Medical Devices.............................................................................. 16

Medical Writing .............................................................................. 16



Outsourcing ..................................................................................... 17


Phase I ............................................................................................. 18

Preclinical ........................................................................................ 18



Risk Management ........................................................................... 20

Software.......................................................................................... 21

Training ............................................................................................ 22


Cofactor Pinnacle

Cofactor Genomics



Cofactor TotalRNA

Cofactor Genomics




miRNAble

Cofactor Genomics



CTMSClinical Trial Management System (CTMS)

Medidata Solutions



Cloudbyz CTMS

Cloudbyz



iSpecimen Marketplace

iSpecimen

450 Bedford Street, Suite 1010Lexington, MA 02420www.ispecimen.com

The iSpecimen Marketplace provides researchers with the specimens they need from the patients they want. It connects healthcare organizations that have access to patients and specimens, including biofluids, solid tissues, and viable cells, with scientists who need them. Researchers log on and gain instant access to millions of specimens anytime, anywhere. Provider organizations gain an opportunity to contribute their specimens compliantly to medical research as well as enhance their bottom line.








http://www.ispecimen.com








Clinical Trials ..................................................................................... 7

Cloud Computing ............................................................................... 7

Consulting ......................................................................................... 8

CRO.................................................................................................... 8

CTMS................................................................................................. 9

Data Analytics ................................................................................. 10

Data Collection................................................................................ 11

Data Monitoring .............................................................................. 12

EDC .................................................................................................. 12

Imaging............................................................................................ 13


Market Data .................................................................................... 15


Medical Devices.............................................................................. 16

Medical Writing .............................................................................. 16



Outsourcing ..................................................................................... 17


Phase I ............................................................................................. 18

Preclinical ........................................................................................ 18



Risk Management ........................................................................... 20

Software.......................................................................................... 21

Training ............................................................................................ 22


On-site Monitoring

Medidata Solutions



Data AnalyticsBioinformatics Services

Systems Imagination



Centralized Statistical Analytics (CSA)

Medidata Solutions








SeqsLab

Atgenomix



Slidematch

microDimensions

Rupert-Mayer-Str. 44 // Gebäude 64.07München, Germany+49 89 189425334micro-dimensions.com

microDimensions Slidematch™ is a simple yet powerful tool that takes a series of whole slide images, aligns all of them accurately, and then saves the aligned images as a new series of whole slide images. This enables correlation and/or masked analyses.







http://micro-dimensions.com








Clinical Trials ..................................................................................... 7

Cloud Computing ............................................................................... 7

Consulting ......................................................................................... 8

CRO.................................................................................................... 8

CTMS................................................................................................. 9

Data Analytics ................................................................................. 10

Data Collection................................................................................ 11

Data Monitoring .............................................................................. 12

EDC .................................................................................................. 12

Imaging............................................................................................ 13


Market Data .................................................................................... 15


Medical Devices.............................................................................. 16

Medical Writing .............................................................................. 16



Outsourcing ..................................................................................... 17


Phase I ............................................................................................. 18

Preclinical ........................................................................................ 18



Risk Management ........................................................................... 20

Software.......................................................................................... 21

Training ............................................................................................ 22


Voloom

microDimensions


microDimensions Voloom® is the most intuitive and automated software solution for 3D histology reconstruction, visualization, and analysis in digital pathology. Voloom helps pharmaceutical, biotechnology, and pathology researchers with cell counting, tumor border computation, scoring, volume measurements, finding regions in serial sections, and many more histology applications.

XIFIN RPM

XIFIN



Zoom

microDimensions


microDimensions Zoom is a free of charge digital pathology viewer for fast visualization of whole slide images and image series. It supports all major proprietary as well as generic file formats.

Data CollectionInsights

Medidata Solutions






Patient Cloud

Medidata Solutions



RaveX

Medidata Solutions


















Clinical Trials ..................................................................................... 7

Cloud Computing ............................................................................... 7

Consulting ......................................................................................... 8

CRO.................................................................................................... 8

CTMS................................................................................................. 9

Data Analytics ................................................................................. 10

Data Collection................................................................................ 11

Data Monitoring .............................................................................. 12

EDC .................................................................................................. 12

Imaging............................................................................................ 13


Market Data .................................................................................... 15


Medical Devices.............................................................................. 16

Medical Writing .............................................................................. 16



Outsourcing ..................................................................................... 17


Phase I ............................................................................................. 18

Preclinical ........................................................................................ 18



Risk Management ........................................................................... 20

Software.......................................................................................... 21

Training ............................................................................................ 22


Trial Assurance

Medidata Solutions


Medidata Trial Assurance is a service that evaluates the integrity and quality of all clinical and lab data within a clinical trial. The offering includes a comprehensive analysis, report and presentation of results. Our customers gain immediate actionable insight to improve clinical trial performance and data quality, which may impact study results and future reviews by regulatory authorities.

XIFIN ProNetXIFIN 12225 El Camino Real San Diego, CA 92130(858) 436-2995www.xifin.com



Data MonitoringCentralized Statistical Analytics (CSA)

Medidata Solutions




Medidata Solutions



EDCOn-site MonitoringMedidata Solutions



RaveXMedidata Solutions


















Clinical Trials ..................................................................................... 7

Cloud Computing ............................................................................... 7

Consulting ......................................................................................... 8

CRO.................................................................................................... 8

CTMS................................................................................................. 9

Data Analytics ................................................................................. 10

Data Collection................................................................................ 11

Data Monitoring .............................................................................. 12

EDC .................................................................................................. 12

Imaging............................................................................................ 13


Market Data .................................................................................... 15


Medical Devices.............................................................................. 16

Medical Writing .............................................................................. 16



Outsourcing ..................................................................................... 17


Phase I ............................................................................................. 18

Preclinical ........................................................................................ 18



Risk Management ........................................................................... 20

Software.......................................................................................... 21

Training ............................................................................................ 22


Risk-Based MonitoringMedidata Solutions


Can a risk-based monitoring (RBM) solution go beyond saving money and actually improve data quality & accelerate treatments to market? Medidata says, “Yes!” Medidata empowers biopharmaceutical companies and CROs to plan, execute, analyze and adjust their studies using a closed-loop adaptive process. With Medidata RBM you can:• Receive immediate benefit • Work seamlessly with Medidata Clinical Cloud®

• Achieve deep sustainable value


Medidata Solutions



Trial Assurance

Medidata Solutions



ImagingDicom Solutions548 WaldIrvine, CA 92618(800) 377-2617dicomsolutions.com/

Dicom Solutions has been serving imaging centers, hospitals, and private practices since 2003, helping them manage their imaging equipment goals. Our mission is to help our customers fulfill their imaging equipment needs by finding the right equipment for the right price, service, and support. We are one of the leading imaging equipment distributors in the US, having an exhaustive inventory of more than 3000 products.

hTME-3DX Screen and VerifyBioDuro

11011 Torreyana RoadSan Diego, CA 92129(858) 552-6690www.bioduro.com

Humanized tumor microenvironment, three-dimensional drug screening and patient-derived xenograft verification platform

Medical ImagingMedidata Solutions


Medidata Medical Imaging is changing the way the industry thinks about imaging in clinical trials. Our system’s intelligent workflows simplify image & data collection and provide automatic edit checks & de-identifcation. The system automates the distribution & review process after image upload. Our structured approach to image submission simplifies workflow and improves efficiency, reducing the time & cost associated with image management & increasing data quality and confidence.





http://dicomsolutions.com/

http://www.bioduro.com









Clinical Trials ..................................................................................... 7

Cloud Computing ............................................................................... 7

Consulting ......................................................................................... 8

CRO.................................................................................................... 8

CTMS................................................................................................. 9

Data Analytics ................................................................................. 10

Data Collection................................................................................ 11

Data Monitoring .............................................................................. 12

EDC .................................................................................................. 12

Imaging............................................................................................ 13


Market Data .................................................................................... 15


Medical Devices.............................................................................. 16

Medical Writing .............................................................................. 16



Outsourcing ..................................................................................... 17


Phase I ............................................................................................. 18

Preclinical ........................................................................................ 18



Risk Management ........................................................................... 20

Software.......................................................................................... 21

Training ............................................................................................ 22


PDOX® Pre-Clinical Research ServicesAntiCancer PDOX, Inc.



SlidematchmicroDimensions



USB3 Vision Processing Unit

Active Silicon




Vevo 3100

FujiFilm VisualSonics, Inc.

3080 Yonge Street Suite 6100Toronto, Canada M4N3N1(416) 580-0258www.visualsonics.com/

The Vevo 3100 is a new and innovative platform created for the future of imaging. It combines ultra high-frequency ultrasound imaging, quantification and education in a convenient easy to use all-in-one platform designed for small animal studies.

Voloom

microDimensions



Zoom

microDimensions







http://www.visualsonics.com/










Clinical Trials ..................................................................................... 7

Cloud Computing ............................................................................... 7

Consulting ......................................................................................... 8

CRO.................................................................................................... 8

CTMS................................................................................................. 9

Data Analytics ................................................................................. 10

Data Collection................................................................................ 11

Data Monitoring .............................................................................. 12

EDC .................................................................................................. 12

Imaging............................................................................................ 13


Market Data .................................................................................... 15


Medical Devices.............................................................................. 16

Medical Writing .............................................................................. 16



Outsourcing ..................................................................................... 17


Phase I ............................................................................................. 18

Preclinical ........................................................................................ 18



Risk Management ........................................................................... 20

Software.......................................................................................... 21

Training ............................................................................................ 22


Lab Supplies/ServicesUniFlow Laboratory Fume Hoods

HEMCO Corporation

711 South Powell RoadIndependence, MO 64056(816) 796-2900www.HEMCOCorp.com

UniFlow Laboratory Fume Hoods are the most complete line of fume hoods in the industry. UniFlow AireStream low flow high performance fume hoods feature an exclusive all composite resin construction that is chemical resistant, flame retardant, lightweight, and meets UL 1805, SEFA 1, ASHRAE 110, and ANSI Z9.5 standards. These hoods have a molded one piece seamless composite resin interior fume chamber that has all coved corners and is white for superior light reflectivity. Available in sizes from 30” to 96” wide and in depths of 24” to 48”, and in CAV (air bypass) or VAV (restricted bypass) models. A wide selection of accessories and services are optional to meet exact user requirements.

Market DataGrants managerMedidata Solutions350 Hudson St., Floor 9New York, NY 10013(212) 918-1800www.mdsol.com





InsightsMedidata Solutions350 Hudson St., Floor 9New York, NY 10013(212) 918-1800www.mdsol.com





Operational Performance Analytics (OPAL)Medidata Solutions350 Hudson St., Floor 9New York, NY 10013(212) 918-1800www.mdsol.com

Medidata OPAL is the only turnkey executive dashboard with operational insights that help life science companies bring drugs to market faster. By benchmarking against the largest store of clinical trial data, OPAL illustrates how organizations perform relative to their peer group. OPAL enables senior executives, therapeutic area leaders & clinical operations management to measure, manage and set goals to improve operational performance across the organization’s clinical trials investments.


http://www.HEMCOCorp.com











Clinical Trials ..................................................................................... 7

Cloud Computing ............................................................................... 7

Consulting ......................................................................................... 8

CRO.................................................................................................... 8

CTMS................................................................................................. 9

Data Analytics ................................................................................. 10

Data Collection................................................................................ 11

Data Monitoring .............................................................................. 12

EDC .................................................................................................. 12

Imaging............................................................................................ 13


Market Data .................................................................................... 15


Medical Devices.............................................................................. 16

Medical Writing .............................................................................. 16



Outsourcing ..................................................................................... 17


Phase I ............................................................................................. 18

Preclinical ........................................................................................ 18



Risk Management ........................................................................... 20

Software.......................................................................................... 21

Training ............................................................................................ 22


Market Research/SurveysUSB3 Vision Processing Unit

Active Silicon




Professional Marketing Services

Cambridge Healthtech Institute Cambridge

HEALTHTECHInstitute

250 First Avenue, Suite 300Needham, MA 02494Phone: 781-972-5400www.proservices.healthtech.com

Looking to increase product sales? Have an upcoming event or webinar that you need audience acquisition for? Cambridge Healthtech Marketing Services provides clients with promotional means to help increase sales, and drive attendance to your event or webinar. If you are looking to boost sales or drive leads to your sales lead, we offer a variety of marketing services including email broadcasts, list rentals, marketing collateral and design, media promotion and other programs to help drive sales and increase market share.

Medical DevicesMedical Imaging

Medidata Solutions



Medical WritingCoder

Medidata Solutions


Medidata Coder is a software-as-a-service (SaaS) solution featuring an easy-to-use, centralized coding environment that synergizes with Medidata Rave® and simplifies dictionary maintenance to deliver • A single, consistent, centralized environment serving all coding teams• Centralized management of distinct coding segments across

therapeutic areas, global & partner teams and regulatory regions • Painless & efficient up-versioning of synonyms & coding decisions



http://www.proservices.healthtech.com










Clinical Trials ..................................................................................... 7

Cloud Computing ............................................................................... 7

Consulting ......................................................................................... 8

CRO.................................................................................................... 8

CTMS................................................................................................. 9

Data Analytics ................................................................................. 10

Data Collection................................................................................ 11

Data Monitoring .............................................................................. 12

EDC .................................................................................................. 12

Imaging............................................................................................ 13


Market Data .................................................................................... 15


Medical Devices.............................................................................. 16

Medical Writing .............................................................................. 16



Outsourcing ..................................................................................... 17


Phase I ............................................................................................. 18

Preclinical ........................................................................................ 18



Risk Management ........................................................................... 20

Software.......................................................................................... 21

Training ............................................................................................ 22


Insight Pharma Reports

Insight Pharma Reports

250 First Avenue, Suite 300Needham, MA 02494Phone: 781-972-5400www.insightpharmareports.com

Insight Pharma Reports are written by experts in consulting and industry who collaborate with us to provide a series of reports that evaluate the salient issues in pharmaceutical technology, business, and therapy markets. Insight Pharma Reports are used by leading pharmaceutical, biotech, diagnostic, consulting, and financial companies to keep abreast of the latest advances in pharmaceutical R&D, their potential applications and business impacts, and their current and future position in the marketplace.

Barnett Educational Services250 First Avenue Suite 300 Needham, MA 02494Phone: 781-972-5400www.barnettinternational.com

This guide provides answers to hundreds of common and emerging questions in 20+ GCP-related areas, including 200+ Q&As updated to reflect the very latest FDA guidances, regulations, comments, and developments. The newly updated 2012 edition is available in both print edition and fully searchable electronic editions.

Mobile TechnologiesPatient Cloud

Medidata Solutions



New Drug ApplicationULTImate YChemH

HYBRIGENICS CORP.

1 BroadwayCambridge, MA 02142(617) 959-7100www.hybrigenics-services.com

ULTImate YChemH is a screening platform for target deconvolution of bioactive compounds to decipher mechanisms of action, identify secondary targets, reposition drugs and predict toxicity.

OutsourcingClinical Trial Management System (CTMS)

Medidata Solutions









http://www.insightpharmareports.com

http://www.barnettinternational.com


https://www.hybrigenics-services.com










Clinical Trials ..................................................................................... 7

Cloud Computing ............................................................................... 7

Consulting ......................................................................................... 8

CRO.................................................................................................... 8

CTMS................................................................................................. 9

Data Analytics ................................................................................. 10

Data Collection................................................................................ 11

Data Monitoring .............................................................................. 12

EDC .................................................................................................. 12

Imaging............................................................................................ 13


Market Data .................................................................................... 15


Medical Devices.............................................................................. 16

Medical Writing .............................................................................. 16



Outsourcing ..................................................................................... 17


Phase I ............................................................................................. 18

Preclinical ........................................................................................ 18



Risk Management ........................................................................... 20

Software.......................................................................................... 21

Training ............................................................................................ 22


Patient RecruitmentCloudbyz CTMS

Cloudbyz




iSpecimen



Phase IULTImate YChemH

HYBRIGENICS CORP.



PreclinicalCofactor FFPExact

Cofactor Genomics



Cofactor mRNAble

Cofactor Genomics


















Clinical Trials ..................................................................................... 7

Cloud Computing ............................................................................... 7

Consulting ......................................................................................... 8

CRO.................................................................................................... 8

CTMS................................................................................................. 9

Data Analytics ................................................................................. 10

Data Collection................................................................................ 11

Data Monitoring .............................................................................. 12

EDC .................................................................................................. 12

Imaging............................................................................................ 13


Market Data .................................................................................... 15


Medical Devices.............................................................................. 16

Medical Writing .............................................................................. 16



Outsourcing ..................................................................................... 17


Phase I ............................................................................................. 18

Preclinical ........................................................................................ 18



Risk Management ........................................................................... 20

Software.......................................................................................... 21

Training ............................................................................................ 22


Cofactor TotalRNA

Cofactor Genomics




miRNAble

Cofactor Genomics



ULTImate YChemH

HYBRIGENICS CORP.



Project ManagementGrants manager

Medidata Solutions






iMedidata

Medidata Solutions


Next Generation Clinical Management Portal: technology should make our lives easier, not create bottlenecks, delay study starts and burden sites and sponsors with potentially dozens of URLs, usernames and passwords. Medidata alleviates all of that with iMedidata: a fast, simple and secure portal to access every study, eLearning course, and centralized user administration.

Operational Performance Analytics (OPAL)

Medidata Solutions


Medidata OPAL is the only turnkey executive dashboard with operational insights that help life science companies bring drugs to market faster. By benchmarking against the largest store of clinical trial data, OPAL illustrates how organizations perform relative to their peer group. OPAL enables senior executives, therapeutic area leaders & clinical operations management to measure, manage and set goals to improve operational performance across the organization’s clinical trials investments.















Clinical Trials ..................................................................................... 7

Cloud Computing ............................................................................... 7

Consulting ......................................................................................... 8

CRO.................................................................................................... 8

CTMS................................................................................................. 9

Data Analytics ................................................................................. 10

Data Collection................................................................................ 11

Data Monitoring .............................................................................. 12

EDC .................................................................................................. 12

Imaging............................................................................................ 13


Market Data .................................................................................... 15


Medical Devices.............................................................................. 16

Medical Writing .............................................................................. 16



Outsourcing ..................................................................................... 17


Phase I ............................................................................................. 18

Preclinical ........................................................................................ 18



Risk Management ........................................................................... 20

Software.......................................................................................... 21

Training ............................................................................................ 22


Quality Risk ManagementTrial Assurance

Medidata Solutions



Risk ManagementBalance

Medidata Solutions


Medidata Balance heralds a new generation of cloud-based Interactive Response Technology (IRT) capabilities. • New user paradigm based on a simple, highly-configurable

interface • Unified with electronic data capture (EDC) system Medidata

Rave® or as a build by Medidata, CRO or sponsor• Superior and agile technology with streamlined design and real-

time visibility into operations

Coder

Medidata Solutions


Medidata Coder is a software-as-a-service (SaaS) solution featuring an easy-to-use, centralized coding environment that synergizes with Medidata Rave® and simplifies dictionary maintenance to deliver • A single, consistent, centralized environment serving all coding teams• Centralized management of distinct coding segments across

therapeutic areas, global & partner teams and regulatory regions • Painless & efficient up-versioning of synonyms & coding decisions

Rave Safety Gateway

Medidata Solutions


Rave Safety Gateway adds advanced adverse events (AEs) and serious adverse events (SAEs) collection and E2B transmission capabilities to the Medidata Rave EDC/CDM platform. Leveraging Rave’s flexibility and the vast amount of safety-related data collected in EDC, Rave Safety Gateway significantly improves the accuracy and speed of safety data collection and transfer to safety systems, for both pre-marketing and post-marketing studies.

Risk-Based Monitoring

Medidata Solutions


Can a risk-based monitoring (RBM) solution go beyond saving money and actually improve data quality & accelerate treatments to market? Medidata says, “Yes!” Medidata empowers biopharmaceutical companies and CROs to plan, execute, analyze and adjust their studies using a closed-loop adaptive process. With Medidata RBM you can:• Receive immediate benefit • Work seamlessly with Medidata Clinical Cloud® • Achieve deep sustainable value














Clinical Trials ..................................................................................... 7

Cloud Computing ............................................................................... 7

Consulting ......................................................................................... 8

CRO.................................................................................................... 8

CTMS................................................................................................. 9

Data Analytics ................................................................................. 10

Data Collection................................................................................ 11

Data Monitoring .............................................................................. 12

EDC .................................................................................................. 12

Imaging............................................................................................ 13


Market Data .................................................................................... 15


Medical Devices.............................................................................. 16

Medical Writing .............................................................................. 16



Outsourcing ..................................................................................... 17


Phase I ............................................................................................. 18

Preclinical ........................................................................................ 18



Risk Management ........................................................................... 20

Software.......................................................................................... 21

Training ............................................................................................ 22


SoftwareiMedidata

Medidata Solutions



Medical Imaging

Medidata Solutions



SeqsLab

Atgenomix



Slidematch

microDimensions




Medidata Solutions



Vevo 3100

FujiFilm VisualSonics, Inc.

3080 Yonge Street Suite 6100Toronto, Canada M4N3N1(416) 580-0258www.visualsonics.com/

The Vevo 3100 is a new and innovative platform created for the future of imaging. It combines ultra high-frequency ultrasound imaging, quantification and education in a convenient easy to use all-in-one platform designed for small animal studies.

Voloom

microDimensions









http://www.visualsonics.com/









Clinical Trials ..................................................................................... 7

Cloud Computing ............................................................................... 7

Consulting ......................................................................................... 8

CRO.................................................................................................... 8

CTMS................................................................................................. 9

Data Analytics ................................................................................. 10

Data Collection................................................................................ 11

Data Monitoring .............................................................................. 12

EDC .................................................................................................. 12

Imaging............................................................................................ 13


Market Data .................................................................................... 15


Medical Devices.............................................................................. 16

Medical Writing .............................................................................. 16



Outsourcing ..................................................................................... 17


Phase I ............................................................................................. 18

Preclinical ........................................................................................ 18



Risk Management ........................................................................... 20

Software.......................................................................................... 21

Training ............................................................................................ 22


XIFIN ProNet

XIFIN




XIFIN RPM

XIFIN



Zoom

microDimensions



TrainingiMedidata

Medidata Solutions



Translational ResearchCofactor Paragon

Cofactor Genomics



Cofactor Pinnacle

Cofactor Genomics

















Clinical Trials ..................................................................................... 7

Cloud Computing ............................................................................... 7

Consulting ......................................................................................... 8

CRO.................................................................................................... 8

CTMS................................................................................................. 9

Data Analytics ................................................................................. 10

Data Collection................................................................................ 11

Data Monitoring .............................................................................. 12

EDC .................................................................................................. 12

Imaging............................................................................................ 13


Market Data .................................................................................... 15


Medical Devices.............................................................................. 16

Medical Writing .............................................................................. 16



Outsourcing ..................................................................................... 17


Phase I ............................................................................................. 18

Preclinical ........................................................................................ 18



Risk Management ........................................................................... 20

Software.......................................................................................... 21

Training ............................................................................................ 22



iSpecimen



PDOX® Pre-Clinical Research Services

AntiCancer PDOX, Inc.







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