1175 Markress Rd, #2632,
USA, 08034
Tel.: +1 856 452-0864
Fax: +1 856 596-8559
E-mail: info@art-clinica.com
ARTClinica Overview
ArtClinica version 1.3
March 2011
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
Optional Services
• Study Set-up:
– CRF development
– Rules configuration
– Documented testing
– Study validation
documentation
ArtClinica
Address: 1175 Marlkress Rd, #2632, Cherry Hill, NJ 08034, USA
• Consulting:
– Needs Analysis /
Requirements Definition
– ARTClinica
Customization
– Validation
– Systems Integration
– Data Migration
– Translation
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
•
•
•
•
ArtClinica
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
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, 08034
Tel.: +1 856 452-0864
Fax: +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