ArtClinica Address: 1175 Marlkress Rd, #2632, Cherry Hill, NJ 08034, USAPhone: Fax: ARTClinica Overview ArtClinica version 1.3 March Markress Rd, #2632, USA, Tel.: Fax:

ArtClinica Address: 1175 Marlkress Rd, #2632, Cherry Hill, NJ 08034, USAPhone: Fax: 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, USAPhone: Fax: 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, USAPhone: Fax: 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, USAPhone: Fax: 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, USAPhone: Fax: 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, USAPhone: Fax: 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, USAPhone: Fax: 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, USAPhone: Fax: 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, USAPhone: Fax: 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, USAPhone: Fax: 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, USAPhone: Fax: 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. ConfigurableAll 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 BasedElectronic data validation is based on rules that may be amended without code changes Multi-site SupportArtClinica 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. InternationalizedArtClinica supports different languages of the User Interface, the language depends on the User’s browser locale UsabilityFunctions accessed via top menu or a single click on a Subject/Event/CRF. Home page content depends on the User’s Role. Data InterchangeImport 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, USAPhone: Fax: 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, USAPhone: Fax: 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, USAPhone: Fax: Screenshots – Top Menu Main functions are easy to access from the Top Menu:

ArtClinica Address: 1175 Marlkress Rd, #2632, Cherry Hill, NJ 08034, USAPhone: Fax: 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, USAPhone: Fax: 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, USAPhone: Fax: 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, USAPhone: Fax: Screenshots – View/Enter Data for Event Example of CRFs set up for Screening Visit:

ArtClinica Address: 1175 Marlkress Rd, #2632, Cherry Hill, NJ 08034, USAPhone: Fax: 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, USAPhone: Fax: Screenshots – Validation Example

ArtClinica Address: 1175 Marlkress Rd, #2632, Cherry Hill, NJ 08034, USAPhone: Fax: Screenshots - SDV Source Data Verification is available on a Monitor’s Home Page:

ArtClinica Address: 1175 Marlkress Rd, #2632, Cherry Hill, NJ 08034, USAPhone: Fax: Screenshots – Notes and Discrepancies

ArtClinica Address: 1175 Marlkress Rd, #2632, Cherry Hill, NJ 08034, USAPhone: Fax: Screenshots – Create Dataset A dataset can be created to export data in various formats:

ArtClinica Address: 1175 Marlkress Rd, #2632, Cherry Hill, NJ 08034, USAPhone: Fax: 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, USAPhone: Fax: 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, USAPhone: Fax: Markress Rd, #2632, USA, Tel.: Fax: