DestinationWashington, DC

2SCDM 2015 ANNUAL CONFERENCE

SCDM lookS forwarD to welCoMing you in waShington, DC

ConferenCe highlightS

• Discover more about the Educational Sessions in the SCDM 2015 annual Conference program, steered by our devoted ConferenceCo-Chairs.

• train yourself and learn the essential skills of preparing and conducting data in different clinical research areas with the Preparing Data for fDa Submission Pre-ConferenceWorkshop.

• Join the interactive Roundtable Sessions, led by CDM industry influencers and thought leaders.

• hear the latest updates on current key topics concerning clinical development and the data management discipline from both the fDa & eMa at the SCDMRegulatoryPanel.

• the SCDM Data innovation task force is happy to present this year’s 2015NextGenTechnologyInnovationAwardcontest. winners will showcase their presentations during a dedicated plenary session on tuesday, September 22.

• Visit the Exhibit Hall and meet our Partners and exhibitors to experience new products and innovative industry technology.

• review SCDM’s PosterPresentations on Monday, September 21 & tuesday, September 22.

• get involved in one of the many networking opportunities available during the conference!

the SCDM2015AnnualConference is just around the corner. SCDM invites you to participate in the largest international educational event for clinical data managers and related professionals. this year, the SCDM 2015 annual Conference will take place at the RenaissanceWashington,DC Downtown Hotel from September 20 to September 23. the conference venue will host all educational sessions, exhibition and social events to ensure that you make the most of your SCDM experience this year again. in addition to our traditional speaker sessions, we are particularly proud to announce that a poster competition will again be organized this year. Besides, a very special SCDM networking reception will take place on tuesday, September 22 as of 7.00 PM at the historic Carnegie library at Mt. Vernon Square.

Welookforwardtoseeingyouthere!

RenaissanceWashington,DCDowntownHotel999 ninth Street nw washington, District of Columbia 20001

RegisterNow!

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TCS is a leading provider of comprehensive Clinical Research Services like Regulatory Affairs, Pharmacovigilance, Clinical Data Management, Risk Based Monitoring, Biostatistics and Programming, Medical Writing & Publishing. With around a decade of experience in working with 12 of the Top 20 Global Pharmaceutical companies, in diverse geographies, TCS, your trusted partner and advisor, will help you in your transformation journey, through its people, platforms and products / services across the value chain. Visit http://www.tcs.com/business-process-services/Pages/clinical-services.aspx

IT ServicesBusiness SolutionsConsulting

4SCDM 2015 ANNUAL CONFERENCE

welCoMe to the SCDM 2015 annual ConferenCe!

NEWCoMERSSESSIoN

this session gives conference newcomers the chance to meet members of the SCDM Board and annual Conference Program Committee, while networking with other newcomers! you will also be presented with the conference program, keynote speaker, the sessions topics, the round-table discussions, the industry sponsors, the poster presentations and social events.

as in previous years, space is limited so early registration is highly recommended.

the official opening reception will follow immediately the newcomers Session. we look forward to seeing you there!

Sunday,September20

05:00 PM – 06:00 PM

LoCATIoN:PENNQUARTER

oPENINGRECEPTIoN

Start your conference experience with the opening reception sponsored by acceliant!

Meet a selection of top industry leaders to learn more about industry trends and enjoy excellent networking opportunities. appetizers and refreshments will be served in comfortable exhibition facilities.

Sunday,September20

06:00 PM – 08:00 PM

LoCATIoN:GRANDBALLRooM

MEDIAPARTNERS

We WoulD like to thank our MeDia Partners for their ContinueD suPPort.

6SCDM 2015 ANNUAL CONFERENCE

PRE-CoNfERENCEWoRkSHoPPREPARINGDATAfoRfDASUBMISSIoN

Sunday,September20

01:00 PM – 05:00 PM

LoCATIoN:MoUNTVERNoNSQUAREB

workShoP leaDer: DaveIzard,ClinicalDataConsultingLead,AccentureAcceleratedR&DServicesforLifeSciences

Content will inCluDe:•history of providing data and related assets to the fDa•fDaSia, PDufa V and the recently finalized binding guidance documents

covering electronic submissions and standardized study data•Submission Data Packages – what to include, how to create them,

things to consider • SDTMdomaindatasets&ADaManalysisdatasets • Datadefinitionfiles(define.xml&define.pdf) • AnnotatedCRFs • StudyDataReviewer’sGuides,AnalysisDataReviewer’sGuides,and

Study Data Standardization Plans•how to effectively design, execute and archive your clinical trial assets

in order to successfully generate submission data packages and related deliverables

•review of live examples of source/legacy and standardized submission data packages

learning oBJeCtiVeS:•understand the foundations for the fDa acceptance of clinical data

and related assets and how the expectations for process and format of these deliverables have recently changed

•Be aware of agency expectations for the use of data standards at the time a study is planned / designed, including the use of CDaSh standards for data collection

•Be capable of executing a clinical trial with a focus on both immediate study execution needs and preserving all assets for use at the point in time final submission deliverables are generated

•Be able to recognize the various assets, including both items generated in a Data Management / eDC setting and those produced by other capabilities

Note: The focus of the seminar is FDA data requirements as FDA is currently the only agency that mandates the submission of actual clinical data. Other agencies will soon do the same (Japan, Canada, Europe) and they will be briefly discussed during the workshop, but the main focus is on the US FDA.

Continuing education Credit: SCDM is authorized by iaCet to offer 0.4 Ceus for this program.

Start your learning exPerienCe with a Pre-ConferenCe funCtion

For more information on these pre-conference functions, please visit www.scdm2015.org

LEADERSHIPfoRUM

Sunday,September20

09:00 aM – 05:00 PM

LoCATIoN:MoUNTVERNoNSQUAREA (upon invitation only)

Putting the patient back in the center of clinical trials is a growing initiative of the industry. But what does this patient centricity movement mean to the discipline of Data Management, the role of Data Managers and the evolution of Data Management as an organization to help further this important strategy?

we have invited several speakers to provide different viewpoints on this important topic. During this one-day event we will hear the opinions of our invited speakers, discuss why this topic is so important nowadays in a panel discussion/ Q&a format. the group will have a chance to ponder questions such as:•how will this affect clinical trials in the future?•what effects will patient centricity have on data management?

•how can data managers help further patient centricity?•what skills / talents will a data manager need to succeed?

with this exclusive event, SCDM seeks to engage CDM leaders, regulators and other stakeholders in a dialogue surrounding key CDM topics and emerging trends, focusing on the patient centricity movement.

leaDerS: •Lindaking,Director,GlobalDataDelivery,EliLilyandCompany•GreggDearhammer,Chiefoperatingofficer,inVentivHealthClinical•RalphRusso,DirectorofGlobalClinicalDataIntegration,Merck

PaneliStS:•AndyLee,SVP,GlobalClinicalTrialoperations,Merck•AnthonyCostello,ChiefExecutiveofficer,Mytrus•JeremyGilbert,VicePresident,Product+Strategy,PatientsLikeMe•Joseph kim,MBA, Senior Advisor, Clinical Innovation, Eli Lilly andCompany

eClinicalOS® is a registered mark of Merge Healthcare Incorporated. © 2015 All rights reserved.866.387.4257 | eClinicalOS.com

Scalable Cost ManagementTalk to us about running trials with exceptional EDC at the most competitive price.

Class-Leading, Modular CapabilitiesBuild full, robust EDC or integrate modules like Endpoint Adjudication or Randomization.

Easy To Use, Faster To DeployReduce training costs and gain competitive advantage through faster implementation.

Have TrialsTake FlightVisit eClinicalOS.com to get started

Visit us at booth #110

8SCDM 2015 ANNUAL CONFERENCE

keynote SPeaker

andy lee is currently the Senior Vice-President of global Clinical trial operations at Merck.andy lee was previously the Deputy head of Clinical Sciences and operations at Sanofi. he was responsible for the execution of clinical trials, across diverse phases and therapeutic areas, around the world to deliver clinical trials to high-quality international gCP and regulatory standards in a timely and cost effective manner.andy has 20 years industry experience conducting clinical studies ranging from pre-clinical to phase iV drug development, across multiple platforms such as devices, small molecules, biologics and gene-therapies. andy is interested in human Subject Protection, Multiregional Studies, Quality and Compliance, operational excellence and finding more efficient ways to run clinical trials. at Sanofi he sponsored the innovation team in Clinical operations.

ANDyLEESVP,GlobalClinicalTrialoperations(Merck)

10SCDM 2015 ANNUAL CONFERENCE

PreView of the eDuCational PrograM

•�how to Bring about Change where you work: lessons from the trenches

•Should this Data be integrated?

•�the evolving role of the Clinical Data Scientist in Modern Drug Development

•�the Balance of efficiencies with Data Quality

•�BigDataManagement:theNeedforaMetadataRepository(MDR)

•�CDM for Medical Device trials

•�academic research organization vs. Contract research organization

•�advances in Clinical trial Data analytics – Practical applications

•�effective Virtual team Management

•�the Data Management Desert: Branching out and leveraging our Skills for Data Success

•�implications of Clinical Data repositories for Data Managers

•�Partnerships, Collaborations, academic alliances, oh My! getting the right Data, right format at the right time

•�Clinical research Data Management and risk Based Monitoring

•�how to fill the gap Between SoPs and Practical work in Data Management

• re-imagining the CDM function in the 21st Century

•��lessons learned in implementing risk-Based Monitoring: the Data Manager’s expanded role

•��Budget innovations, Big impact: Department Created tools that added efficiency in Data Management

•��eSource – what’s holding us Back?

•��Quality Management Systems- how to Shift from fixing Problems to Preventing them

•��CfaSt therapeutic area Standards Development – goals, Process and impact to Clinical trials & regulatory Submissions

•��Surviving a Changing industry

•��outsourcing of CDM to China and india: an evolving landscape

WearedelightedtobringyouanothersetofstimulatingeducationaltopicsinthefieldofClinicalDataManagement!Pickandchoosethesessionsthatsuityoureducationalandlearningneedsbest.

12SCDM 2015 ANNUAL CONFERENCE

regulatory Panel

PoSter PreSentationS

SeSSion MoDerator: Demetris Zambas, VP & Global Head, Data Management, NovartisPharmaceuticalsCorporation

PaneliStS:SteveWilson,Dr.P.H,Director,fDA/CDER/oTS/oB/DBIII

the eighth annual SCDM regulatory forum will offer participants an opportunity to engage our panelists from both the fDa and eMa on current key topics concerning Clinical Development and the Data Management discipline. in addition to specific updates the panelists will provide, participants will be offered to the opportunity to submit

questions during a survey period prior to the session as well as during the Q & a portion of the session.

Join the panelists on Monday, September 21, and seize the opportunity to make your voice heard by submitting your questions now to annualconference@scdm.org.

Do not miss the chance to determine what’s critical to our regulators, to your peers, to you and your organization.

Monday,September21

03:30 PM - 05:00 PM

LoCATIoN:RENAISSANCEBALLRooM

During last year’s annual Conference, you had the opportunity to experience Poster Presentations for the first time at an SCDM annual Conference. Based on the positive feedback and the outstanding success that we received, we are pleased to launch a second edition.

a jury of experts will select the winners of the three best posters, which will be awarded as follows:

•�1st prize 300 $•�2nd prize 200 $•�3rd price 100 $

Visit the SCDM 2015 annual Conference website where a sneak peek of the posters is showcased!

the prizes will be awarded in the exhibit hall on tuesday, September 22, 3 PM.

SCDM would like to thank waife & associates, inc., a process-optimization consultancy devoted entirely to clinical research, for sponsoring the Poster Presentation awards.

SeSSion leaDer:Richardf.Ittenbach,PhD,ProfessorofPediatrics,CincinnatiChildren’sHospitalMedicalCenter

Monday,September21andTuesday,September22

12:00 PM - 01:00 PM

LoCATIoN:foyERGRANDBALLRooM

VisittheSCDM2015AnnualConferencewebsitewhereasneakpeekofthepostersisshowcased!

Data and Documents: The New Gold Standard of eSource

BOOTH #306Clinical

eSource | Remote Monitoring | Patient Engagement

Meet Clinical Ink’s Chief Data Officerand learn why eSource is the new gold standard for data collection.

eSource - What’s Holding Us Back?Jonathan Andrus

Chief Data Officer, Clinical Ink

Wednesday, September 238:30-10am

ert.com

ERT Rater Training - uniquely provides customized, online and on-device rater training for Clinicians, Caregivers, Subjects and Site Staff. Blended instruction on each instrument’s design and scales, electronic implementation, and interviewing techniques - all in one. Plus Rater Performance Monitoring.

ert.com/rater-training

ELECTRONIC RATER TRAINING FOR SITES, CAREGIVERS AND PATIENTS

14SCDM 2015 ANNUAL CONFERENCE

NexTGeNTeChNoloGyINNovATIoNAwARD(TIA)

TheNextGenTechnologyInnovationAward(TIA)isthesuccessoroftheSCDM DDia, created in 2007 to recognize important vendor/sponsor relationships and to build awareness of new technologies and innovative solutions in the Clinical Data Management field. the purpose of the tia is to identify innovation which leverages the use of novel technologies or processes and provide relevant paradigms for how it could be used in clinical trials. attend the technology innovation award finalists’ Presentations during SCDM’s 2015 annual Conference to discover the finalists for the best industry innovation.

MoDerator :MichelleNusser-Meany,GroupHead,oncologyClinicalDataStandards,Novartisoncology

Tuesday,September22

10:30 aM – 11:15 aM

LoCATIoN:RENAISSANCEBALLRooM

YOUR KNOWLEDGE, OUR NETWORKLearn how inVentiv jump-starts careers andsolves problems in data management.

Visit booth 504 for details.

inVentivHealth.com

#IngenuitySquared harris.com

More than 30 years delivering expert clinical research support services to the National Institutes of Health Highly-trained, medical and clinical research experts at Harris integrate industry-best practices in clinical data management, clinical informatics and clinical monitoring to save costs and improve performance of across clinical trials. For more information about Harris’ government healthcare services, visit itservices.harris.com/healthcare. Harris and Exelis have joined forces — creating a stronger company with the scale, capabilities, and commitment to innovation and excellence to deliver even greater value to our customers. Discover how the new Harris better connects, informs and protects the world at harris.com/welcome.

16SCDM 2015 ANNUAL CONFERENCE

SPonSorSknoWleDge Partner

CaPitol PaCkage - DiaMonD sPonsors

White house PaCkage - PlatinuM sPonsors

Washington MonuMent PaCkage - golD sPonsors

sMithsonian PaCkage - silver sPonsors

17SCDM 2015 ANNUAL CONFERENCE

oPENINGHoURS:

Sunday, September 20 06:00 PM – 08.00 PM Monday, September 21 10:00 aM – 06.00 PM tuesday, September 22 10:00 aM – 03.30 PM

LoCATIoN:GRANDBALLRooM

ViSit our DeDiCateD VenDorS

BooTHNUMBER CoMPANy

108 acceliant507 adaptive Clinical Systems213 almac group516 aris global106 AssociationofClinicalResearchProfessionals(ACRP)313 axiom real-time Metrics, inc.316 BioClinica, inc.408 Brightech international, inc.212 CDISC(ClinicalDataInterchangeStandards

Consortium,Inc)

310 ClinDatrix, inc.505 Clinical Conductor CtMS & eDC306 Clinical ink409 Clinical Solutions group, inc.515 Clinical Studio208 Clinovo206 Comprehend Systems303 Crf health415 Cytel, inc.513 Dacima Software inc.514 DDi - Drug Development informatics307 DSg, inc.105 eClinical Solutions, llC414 entimo ag204 ert, inc. 207 forte research Systems, inc.503 fortress Medical Systems, llC314 gCe Solutions, inc.216 genae associates nV305 gilead Sciences, inc.

BooTHNUMBER CoMPANy

103 harris416 integrated Clinical Systems, inc.311 integrated resources, inc.504 inVentiv health Clinical312 Maxisit, inc.411 Medidata Solutions406 Mednet Solutions203 Medrio110 Merge healthcare210 nextrials214 nnit410 omniComm Systems, inc.413 openClinica, llC509 oracle404 Parexel informatics109 Pinnacle 21, llC506 Pra health Sciences215 Promedica international209 ProMetrika114 Quartesian, llC104 Quintiles211 Sidus BioData308 Statistics&DataCorporation(SDC)403 talentMine116 tata Consultancy Services112 technical resources international, inc.309 theorem Clinical research, inc.304 uppsala Monitoring Centre412 Viedoc405 wincere, inc.

18SCDM 2015 ANNUAL CONFERENCE

TATA

tCS’ data driven platforms derive insights and helps drive informed decisions across the drug development space. it leverages predictive analytics and integrates key risk indicators to assess static and dynamic risks during the study. tCS is recognized as a leader in life Sciences r&D risk-Based Monitoring by iDC MarketScape.

Tuesday,September22

07:15 aM - 08:00 aM

LoCATIoN:RENAISSANCEBALLRooMEAST

WINCERE

Join wincere to see how txDesigner can help manage Crf standards, produce customized PDf layouts, and compress study build timelines.

Tuesday,September22

07:15 aM - 08:00 aM

LoCATIoN:RENAISSANCEBALLRooMWEST

oMNICoMM

the presentation will include examples of direct data capture for labora-tory data, direct instrument capture, ePro and ehr/eDC integration.

Wednesday,September23

07:15 aM - 08:00 aM

LoCATIoN:RENAISSANCEBALLRooMEAST

oRACLE

Discover how to make global trial set-up and implementation faster with reusable workflows, and easily enable consistent, deep data cleansing with automated consolidation of multiple data sources.

Wednesday,September23

07:15 aM - 08:00 aM

LoCATIoN:RENAISSANCEBALLRooMWEST

ProDuCt DeMonStrationS

The World’sMost InnovativeEDC Softwarefor Phase I-IVClinical Trials.

innovativeintuitiveinteroperable

1.877.468.6332 www.omnicomm.com

Full Page Trade Show Print Ad 8.5x11 OMNI-14201 v3.indd 1 7/24/14 11:01 AM

20SCDM 2015 ANNUAL CONFERENCE

green Meeting initiatiVeS

ConferenCe extraS

EXHIBITHALLBINGoCARDSCDM 2015 annual Conference participants receive a Bingo Card in their conference tote bags and they are invited to visit all participating exhibitors listed on the card. each participating exhibitor will stamp or initial their listing to confirm that the participant visited their booth to learn about the products and services they offer. when all of the listings have been marked, the participant will drop their Bingo Card off at the SCDM onsite registration desk to enter in a drawing to win a variety of conference perks!

ThedrawingtakesplaceintheExhibitHall(GrandBallroom)onTuesday,September22,at3PM.

SCDMNETWoRkINGRECEPTIoNJoin us at this years’ SCDM networking reception on tuesday, September 22 at 7 PM at the historic Carnegie library at Mt. Vernon Square, located accross the street from the conference hotel. the Carnegie library is an elegant construction and an integral part of the two-hundred-year history of Mt. Vernon Square.

Do not miss out on this great networking opportunity in this historic landmark, co-sponsored by omniComm, oracle and wincere. take advantage of high quality discussions and exchanges with your peers and colleagues while enjoying drinks and a light walking buffet dinner.

as spaces are limited and will be managed on a first-come first served basis, we invite you toregisternow.

SCDM is committed to doing its part to preserve the earth. this year, the SCDM 2015 annual Conference will take the following steps to reduce the environmental impact:

•�Provide recycling bins throughout the exhibit hall to reduce waste

•�Produce a digital preliminary program and call for abstracts to reduce unnecessary printing

•�Centralize the social events within the venue to reduce additional travel

Here’swhatyoucandotohelp:

•�recycle your conference program and printed materials

•�Carpool

•�recycle your badge and return it to the registration desk before leaving

22SCDM 2015 ANNUAL CONFERENCE

welCoMe to waShington, DC!

traVel & aCCoMMoDation

ABoUToURHoSTCITy

washington, DC, also referred to as the District of Columbia, washington, the District, or DC, is unique among american cities: it was established by the Constitution of the united States to serve as the nation’s capital. washington, DC is not only the home to the federal government, but it is also a cosmopolitan city with a variety of opportunities that attract residents and visitors from around the world.

fAMoUSWASHINGToNIANS

•�Robert F. Kennedy Jr. (b. 1954 in washington, DC), environmentalactivist, radio talk Show host, lawyer.

•�Dave Chappelle (b. 1973 in washington, DC), Film Actor, Televisionactor, Comedian, Producer.

•�QueenNoorofJordan(b.1951inwashington,DC),Queen.

LoCALATTRACTIoNS

•NationalGalleryofArt

•�LincolnMemorialandReflectingPool

•�Smithsonian

•LibraryofCongress

•NationalMall

•ThreeHousesofGovernment

•�TakeaWalkThroughGeorgetown

•�SeeaShoworConcertatthekennedyCenter

•NationalWorldWarIIMemorial

•�Newseum

AIRPoRTS

RonaldReaganWashingtonNationalAirportarlington, Va 22202, united States

WashingtonDullesInternationalAirport1 Saarinen Cir, Dulles, Va 20166, united States

STAyINGINWASHINGToNDC

SCDM has negotiated this year again special reduced room rates for your stay in washington at the renaissance washington, DC Downtown hotel, during the SCDM 2015 annual Conference.

BookyoURACCoMMoDATIoN

the Conference hotel is fully booked for the nights of September 19 & 22, thus we would like to invite you to book your accommodation with the following overflow hotels: the MarriottMarquis and MarriottMetroCenter. Please note that we do not have preferential rates for these venues.

reservations at the special reduced room rate of $189.00+ are accepted until friday, august 28, 2015 for the nights of 20 & 21 September.

any reservation requests submitted after this date are based on a space and rate-available basis.

all reservations must be accompanied by a first night room deposit or guaranteed with a major credit card by each individual guest. hotel check in time is 3:00 PM. Check out time is 12:00 PM.

䴀愀砀椀洀椀稀攀 琀栀攀 瘀愀氀甀攀 漀昀 礀漀甀爀 挀氀椀渀椀挀愀氀 搀愀琀愀 眀椀琀栀 䌀刀䘀 䠀攀愀氀琀栀⸀ 嘀椀猀椀琀 戀漀漀琀栀 ⌀㌀　㌀ 昀漀爀 愀 挀栀愀渀挀攀 琀漀 眀椀渀 愀渀 䄀瀀瀀氀攀 圀愀琀挀栀⸀

圀圀圀⸀䌀刀䘀䠀䔀䄀䰀吀䠀⸀䌀伀䴀

䐀䔀䴀䄀一䐀䐀䔀倀䔀一䐀䄀䈀䰀䔀 䐀䄀吀䄀

䌀氀攀愀渀Ⰰ 挀漀渀猀椀猀琀攀渀琀 搀愀琀愀 椀猀 攀猀猀攀渀琀椀愀氀 昀漀爀 琀栀攀 猀甀挀挀攀猀猀 漀昀 礀漀甀爀 挀氀椀渀椀挀愀氀 琀爀椀愀氀⸀ 一漀 漀琀栀攀爀 攀䌀伀䄀 猀漀氀甀琀椀漀渀 椀猀 愀猀 瀀爀漀瘀攀渀 愀猀 吀爀椀愀氀䴀愀砀글 椀渀 挀漀氀氀攀挀琀椀渀最 挀氀椀渀椀挀愀氀 漀甀琀挀漀洀攀猀 愀猀猀攀猀猀洀攀渀琀 搀愀琀愀⸀ 䴀愀椀渀琀愀椀渀 挀漀洀瀀氀椀愀渀挀攀Ⰰ 猀攀挀甀爀攀氀礀 椀渀琀攀最爀愀琀攀 眀椀琀栀 礀漀甀爀 䔀䐀䌀 猀礀猀琀攀洀Ⰰ 愀渀搀 爀攀挀攀椀瘀攀 栀椀最栀ⴀ焀甀愀氀椀琀礀 搀愀琀愀 愀挀挀漀爀搀椀渀最 琀漀 琀栀攀 瀀爀攀挀椀猀攀 爀攀焀甀椀爀攀洀攀渀琀猀 漀昀 礀漀甀爀 猀琀甀搀礀 瀀爀漀琀漀挀漀氀⸀

䄀一䐀 䄀一 䄀倀倀䰀䔀 圀䄀吀䌀䠀 ⨀

⨀

View demos of technology-enabled trials in BOOTH #316 at SCDM

What are you MISSING in your CLINICAL TRIAL?

Compass Intelligent Monitoring | Express EDC & Data Management Consulti ngOpti mizer and Trident Randomizati on & Trial Supply Management (RTSM)

BioClinica sees DEEPER,

fi nding both RISKS − and

OPPORTUNITIES.

Oracle Health Sciences Data Management Workbench (DMW)

Accelerating Data Cleansing, Integration and Analysis from Source to Submission

See a demo and discover more at Oracle Health Sciences booth #509/511, for a chance to win an Apple Watch.

The industry’s only, true, end-to-end, clinical data management solution for data cleansing, integration

and analysis. For more information visit: www.oracle.com/goto/DMW

ORACLE HEALTH SCIENCES DATA MANAGEMENT WORKBENCH (DMW)

Copyright © 2015, Oracle and/or its affiliates. All rights reserved. Oracle and Java are registered trademarks of Oracle and/or its affiliates. Other names may be trademarks of their respective owners. 22239 0106014

• Perform analysis earlier. Spot trends and anomalies sooner.

• Increase quality while minimizing programming burden with automated work-flows and advanced data acquisition/ transformation/ cleansing.

DMW accelerates the speed and accuracy of clinical trial set-up, as well as clinical data acquisition, reconciliation, aggregation and analysis.

OPTIMIZE CLINICAL DATA MANAGEMENT

ADVANCE CLINICAL TRIAL OPERATIONS

• Make global trial set-up and implementation easy with reusable workflows.

• Enable consistent, deep data cleansing with consolidation of data sources.

With advanced data processing, DMW quickly delivers high-quality data to biostats for analyses.

=

STREAMLINE CLINICAL TRIAL DEVELOPMENT

• Streamline cleansing and transformations based on standards with advanced mechanisms for operational re-use.

• Simplify integration with data providers, such as CROs and central labs.

DMW’s single solution environment enables better data integration and facilitates easy adoption of industry standards.

ENRICHBIOSTATS

• Deliver validated data to biostats faster and easier.

• Develop biostatistical analyses with clean, structure-ready, delivered data.

DMW delivers the right data, to the right teams, in the right structures.It frees biostatisticians to focus on rapid knowledge exploration to drive more successful submissions.

Advanced technology is enabling faster, easier and more accurate clinical trial data collection and validation than ever before.

25SCDM 2015 ANNUAL CONFERENCE

THANkyoU!the Society for Clinical Data Management would like to thank all of its members, volunteers,

and sponsors who have supported us throughout the years.

we appreciate the joint commitment and contribution to deliver valuable education and innovative programs to the SCDM 2015 annual Conference.

Mark your calendar and make sure you join us next year in San Diego, Ca, as we embark on the next Clinical Data Management chapter!

GET FAST, ACCURATE DATA

DATALABS® EDC

TO LEARN MORE:

Stop by booth #404

Visit our website

© 2015 PAREXEL International Corporation. All rights reserved.

Connectinginsights

Better outcomes

Superior delivery

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Creating a healthier world demands a new way of working together. A broader understanding of medicines and

markets. Data visibility to refi ne strategy and prove value. With an integrated view of the healthcare continuum,

Quintiles is building biopharma and life sciences solutions — from pipeline to portfolio to population health™.

How can we help you? U.S. toll-free in-country: +1 866 267 4479Email: success@quintiles.com Or learn more at quintiles.com