artclinica address: 1175 marlkress rd, #2632, cherry hill, nj 08034, usaphone: +1 856 452-0864 fax:...

ArtClinica Address: 1175 Marlkress Rd, #2632, Cherry Hill, NJ 08034, USA Phone: +1 856 452-0864 Fax: +1 856 596-8559 Email: info@art-clinica.com

ARTClinica OverviewArtClinica version 1.3

March 2011

1175 Markress Rd, #2632,USA, 08034

Tel.: +1 856 452-0864Fax: +1 856 596-8559

E-mail: info@art-clinica.com

ArtClinica Address: 1175 Marlkress Rd, #2632, Cherry Hill, NJ 08034, USA Phone: +1 856 452-0864 Fax: +1 856 596-8559 Email: info@art-clinica.com

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: info@art-clinica.com

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: info@art-clinica.com

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: info@art-clinica.com

• 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: info@art-clinica.com

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: info@art-clinica.com

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: info@art-clinica.com

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: info@art-clinica.com

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: info@art-clinica.com

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: info@art-clinica.com

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: info@art-clinica.com

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: info@art-clinica.com

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: info@art-clinica.com

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: info@art-clinica.com

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: info@art-clinica.com

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: info@art-clinica.com

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: info@art-clinica.com

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: info@art-clinica.com

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: info@art-clinica.com

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: info@art-clinica.com

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: info@art-clinica.com

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: info@art-clinica.com

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: info@art-clinica.com

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: info@art-clinica.com

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: info@art-clinica.com

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: info@art-clinica.com

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