artclinica address: 1175 marlkress rd, #2632, cherry hill, nj 08034, usaphone: +1 856 452-0864 fax:...
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ArtClinica Address: 1175 Marlkress Rd, #2632, Cherry Hill, NJ 08034, USA Phone: +1 856 452-0864 Fax: +1 856 596-8559 Email: [email protected]
ARTClinica OverviewArtClinica version 1.3
March 2011
1175 Markress Rd, #2632,USA, 08034
Tel.: +1 856 452-0864Fax: +1 856 596-8559
E-mail: [email protected]
ArtClinica Address: 1175 Marlkress Rd, #2632, Cherry Hill, NJ 08034, USA Phone: +1 856 452-0864 Fax: +1 856 596-8559 Email: [email protected]
Who can use ARTClinica ?
CRO companies managing any size study
Bio-Pharma companies with a need for a lightweight integrated SaaS solution Trial sponsors
Independent clinics
Imaging labs – optional MI support
ArtClinica Address: 1175 Marlkress Rd, #2632, Cherry Hill, NJ 08034, USA Phone: +1 856 452-0864 Fax: +1 856 596-8559 Email: [email protected]
Why ARTClinica ?
EDC/CTMS/IVR 3-in-1 solution
Shared eHub
Secure Hosting
Rapid deployment
Quick study setup
Easy eCRF setup
ArtClinica Address: 1175 Marlkress Rd, #2632, Cherry Hill, NJ 08034, USA Phone: +1 856 452-0864 Fax: +1 856 596-8559 Email: [email protected]
Why ARTClinica ?
Optimal study design as each study is set up independently
Low study start-up and ongoing costs
Sophisticated data extraction tools
Affordable customization and tailoring by request
and…
Comprehensive training
24/7 technical support
ArtClinica Address: 1175 Marlkress Rd, #2632, Cherry Hill, NJ 08034, USA Phone: +1 856 452-0864 Fax: +1 856 596-8559 Email: [email protected]
• Study Set-up:– CRF development– Rules configuration– Documented testing– Study validation
documentation
• Consulting:– Needs Analysis /
Requirements Definition – ARTClinica
Customization– Validation– Systems Integration– Data Migration– Translation
Optional Services
ArtClinica Address: 1175 Marlkress Rd, #2632, Cherry Hill, NJ 08034, USA Phone: +1 856 452-0864 Fax: +1 856 596-8559 Email: [email protected]
Our Hosting
• ARTClinica hosting maintains SAS 70 Type II audit certification and meets ISO 27002:2005 standards for information security
• Data Center Statement and associated documentation are available to customers as part of a vendor audit
ArtClinica Address: 1175 Marlkress Rd, #2632, Cherry Hill, NJ 08034, USA Phone: +1 856 452-0864 Fax: +1 856 596-8559 Email: [email protected]
Product Components
ARTClinica is a Software as a Service (SaaS) based integrated solution optimized for data capture and data entry
The following facilities are included:– Electronic Data Capture (EDC)– Clinical Trial Management (CTMS)– Clinical Data Management (CDMS)– Interactive Voice Response System (IVRS) Module(optional) – Interactive Web Response (IWR) Module(optional)
ArtClinica Address: 1175 Marlkress Rd, #2632, Cherry Hill, NJ 08034, USA Phone: +1 856 452-0864 Fax: +1 856 596-8559 Email: [email protected]
Key Functionality• Build Study: facilitates creation and management of study protocols, sites,
eCRFs, users and study event definitions• Data Capture: subject enrollment, visit data capturing• Monitoring and Management of Data: review data, raise Notes and
Discrepancies, Source Data Verification & sign Subjects/Case Report Forms• Extract Data: a powerful set of tools for defining and extracting clinical
data sets• Administration: tools for overall system oversight, auditing, configuration,
and reporting• Interactive Voice Response System (optional)• Interactive Web Response Module (optional)
ArtClinica Address: 1175 Marlkress Rd, #2632, Cherry Hill, NJ 08034, USA Phone: +1 856 452-0864 Fax: +1 856 596-8559 Email: [email protected]
Additional Features
• Multiple- and Single-site Studies supported• CRF data format and validation may be amended during the
Study if a Protocol Amendment needs to be reflected• Data change requests are supported• Visit structure can be amended after enrollment
ArtClinica Address: 1175 Marlkress Rd, #2632, Cherry Hill, NJ 08034, USA Phone: +1 856 452-0864 Fax: +1 856 596-8559 Email: [email protected]
User Roles
• A User may be assigned to several Studies and/or Sites with a different Role
• Study (Sponsor) Level Roles– Data Manager– Study Director– Data Specialist– Monitor– Data Entry Person
• Site Level Roles– Investigator– Monitor– Clinical Research Coordinator (CRC)
ArtClinica Address: 1175 Marlkress Rd, #2632, Cherry Hill, NJ 08034, USA Phone: +1 856 452-0864 Fax: +1 856 596-8559 Email: [email protected]
User’s Primary Functions
• Data Manager, Study Director (Study Level)– Set up Studies, Sites, CRFs, Event Definitions and Subjects– Import and Extract Data– Manage Notes & Discrepancies
• Clinical Research Coordinator (Site Level)– View and add Subjects and Events– Capture CRF data
• Monitor (Study or Site Level)– Perform Source Data Verification– View Subjects and Events (at their level)– Notes & Discrepancies
• Investigator (Site Level)– Sign subject data– Manage Data Sets
ArtClinica Address: 1175 Marlkress Rd, #2632, Cherry Hill, NJ 08034, USA Phone: +1 856 452-0864 Fax: +1 856 596-8559 Email: [email protected]
ArtClinica Characteristics
FDA CFR 21 Part 11 Compliant
Proper authorization for users. Full clinical data audit. Subject/Event data signing requires electronic signature. Access to data based on the User’s Role.
Configurable All data capture forms are highly configurable due to CRFs that determine forms content and reference data and may be amended during the Study by uploading new CRF versions.ArtClinica supports multiple Visit Arms if configured for a Study.
Rules Based Electronic data validation is based on rules that may be amended without code changes
Multi-site Support ArtClinica supports both single- and multi-site Studies. A User may participate in several studies and/or sites with a different role.
Provides Means for Communication
ArtClinica provides users with a possibility for communication by means of Notes and Discrepancies that can then be tracked and (re-) assigned as appropriate.
Internationalized ArtClinica supports different languages of the User Interface, the language depends on the User’s browser locale
Usability Functions accessed via top menu or a single click on a Subject/Event/CRF. Home page content depends on the User’s Role.
Data Interchange Import of electronic data (CDISC ODM XML 1.2) and extraction of data (tab delimited, html, CDISC ODM XML 1.2/1.3 etc.)
ArtClinica Address: 1175 Marlkress Rd, #2632, Cherry Hill, NJ 08034, USA Phone: +1 856 452-0864 Fax: +1 856 596-8559 Email: [email protected]
Screenshots – Build Study
• Build Study following a task based approach (each task has additional details and actions):
ArtClinica Address: 1175 Marlkress Rd, #2632, Cherry Hill, NJ 08034, USA Phone: +1 856 452-0864 Fax: +1 856 596-8559 Email: [email protected]
Screenshots – Overall Study Status
• The home page of a Data Manager provides overall Study status:
ArtClinica Address: 1175 Marlkress Rd, #2632, Cherry Hill, NJ 08034, USA Phone: +1 856 452-0864 Fax: +1 856 596-8559 Email: [email protected]
Screenshots – Top Menu
• Main functions are easy to access from the Top Menu:
ArtClinica Address: 1175 Marlkress Rd, #2632, Cherry Hill, NJ 08034, USA Phone: +1 856 452-0864 Fax: +1 856 596-8559 Email: [email protected]
Screenshots – Change Study/Site
• A User can switch between studies and sites that he/she has access to:
ArtClinica Address: 1175 Marlkress Rd, #2632, Cherry Hill, NJ 08034, USA Phone: +1 856 452-0864 Fax: +1 856 596-8559 Email: [email protected]
Screenshots – Subject Matrix
• Overall information for Subjects and Events status is accessible through the Subject Matrix• The Subject Matrix can be filtered by an Event Type• Data entry and other functions are accessed via a single click• Subject Matrix is displayed at the Home Page for CRCs
ArtClinica Address: 1175 Marlkress Rd, #2632, Cherry Hill, NJ 08034, USA Phone: +1 856 452-0864 Fax: +1 856 596-8559 Email: [email protected]
Screenshots – Add Subject
• It is easy to add a number of Subjects. Fields available on the Add Subject page are configurable at the Study Level.
ArtClinica Address: 1175 Marlkress Rd, #2632, Cherry Hill, NJ 08034, USA Phone: +1 856 452-0864 Fax: +1 856 596-8559 Email: [email protected]
Screenshots – View/Enter Data for Event
• Example of CRFs set up for Screening Visit:
ArtClinica Address: 1175 Marlkress Rd, #2632, Cherry Hill, NJ 08034, USA Phone: +1 856 452-0864 Fax: +1 856 596-8559 Email: [email protected]
Screenshots – CRF Example
• Example of CRF data (Study, Subject, Event, Interviewer Summary not displayed on the screenshot):
ArtClinica Address: 1175 Marlkress Rd, #2632, Cherry Hill, NJ 08034, USA Phone: +1 856 452-0864 Fax: +1 856 596-8559 Email: [email protected]
Screenshots – Validation Example
ArtClinica Address: 1175 Marlkress Rd, #2632, Cherry Hill, NJ 08034, USA Phone: +1 856 452-0864 Fax: +1 856 596-8559 Email: [email protected]
Screenshots - SDV
• Source Data Verification is available on a Monitor’s Home Page:
ArtClinica Address: 1175 Marlkress Rd, #2632, Cherry Hill, NJ 08034, USA Phone: +1 856 452-0864 Fax: +1 856 596-8559 Email: [email protected]
Screenshots – Notes and Discrepancies
ArtClinica Address: 1175 Marlkress Rd, #2632, Cherry Hill, NJ 08034, USA Phone: +1 856 452-0864 Fax: +1 856 596-8559 Email: [email protected]
Screenshots – Create Dataset
• A dataset can be created to export data in various formats:
ArtClinica Address: 1175 Marlkress Rd, #2632, Cherry Hill, NJ 08034, USA Phone: +1 856 452-0864 Fax: +1 856 596-8559 Email: [email protected]
Choose ARTClinica because…
EDC/CTMS/IVR 3-in-1 solution
Shared eHub
Secure Hosting
Rapid deployment
Quick study setup
Easy eCRF setup
ArtClinica Address: 1175 Marlkress Rd, #2632, Cherry Hill, NJ 08034, USA Phone: +1 856 452-0864 Fax: +1 856 596-8559 Email: [email protected]
Choose ARTClinica because…
Low study start-up and ongoing costs
Sophisticated data extraction tools
Affordable customization and tailoring by request
and…
Comprehensive training
24/7 technical support
ArtClinica Address: 1175 Marlkress Rd, #2632, Cherry Hill, NJ 08034, USA Phone: +1 856 452-0864 Fax: +1 856 596-8559 Email: [email protected]
1175 Markress Rd, #2632,USA, 08034Tel.: +1 856 452-0864Fax: +1 856 596-8559E-mail: [email protected]