ART Clinica Overview

1. ARTClinicaOverview ArtClinica version 1.3 March 2011

2. Who can useARTClinica? • 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

3. Why ARTClinica? • EDC/CTMS/IVR 3-in-1 solution • Shared eHub • Secure Hosting • Rapid deployment • Quick study setup • Easy eCRF setup

4. 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

5. Optional Services • Consulting: • Needs Analysis / Requirements Definition • ARTClinica Customization • Validation • Systems Integration • Data Migration • Translation • Study Set-up: • CRF development • Rules configuration • Documented testing • Study validation documentation

6. 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

7. 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)

8. 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)

9. 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

10. 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)

11. 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

12. ArtClinica Characteristics

13. Screenshots – Build Study • Build Study following a task based approach (each task has additional details and actions):

14. Screenshots – Overall Study Status • The home page of a Data Manager provides overall Study status:

15. Screenshots – Top Menu • Main functions are easy to access from the Top Menu:

16. Screenshots – Change Study/Site • A User can switch between studies and sites that he/she has access to:

17. 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

18. 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.

19. Screenshots – View/Enter Data for Event • Example of CRFs set up for Screening Visit:

20. Screenshots – CRF Example • Example of CRF data (Study, Subject, Event, Interviewer Summary not displayed on the screenshot):

21. Screenshots – Validation Example

22. Screenshots - SDV • Source Data Verification is available on a Monitor’s Home Page:

23. Screenshots – Notes and Discrepancies

24. Screenshots – Create Dataset • A dataset can be created to export data in various formats:

25. Choose ARTClinica because… • EDC/CTMS/IVR 3-in-1 solution • Shared eHub • Secure Hosting • Rapid deployment • Quick study setup • Easy eCRF setup

26. 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

27. 1175 Markress Rd, #2632, USA, 08034 Tel.: +1 856 452-0864 Fax: +1 856 596-8559 E-mail: info@art-clinica.com