ABR Electronic Data Capture (EDC) – ClinPlus® Data Management
ABR has extensive experience in traditional paper CRF solutions, using Oracle
Clinical™ and several electronic data capture (EDC) solutions, including Phase
Forward InForm, etrials eClinical, and pharmaceutical customized EDC
software applications. Until recently, EDC solutions have often been prohibitively
expensive for many smaller biopharmaceutical companies to employ in Phase 2 and 3
clinical studies.
ABR has partnered with ClinPlus to offer a cost-effective web-based Electronic Data
Capture (EDC) system, ClinPlus Data Management 3.0, for clinical data management to
achieve fully integrated study control and data management and reduce the time from start
of study to database lock. We believe this EDC system, coupled with the ABR Study
Tracker™, ABR’s proprietary clinical trials management tool, are essential components to
enable us to meet the aggressive study timelines for critical studies.
The EDC system benefits include:
• Web-based access for data entry and review via the internet using
Citrix technologies.
• Data entered directly from study sites
• Reduced paper handling by allowing data entry into electronic CRFs (eCRFs)
• Reduced data entry errors by eliminating paper CRFs
• Error checking during data entry at the sites allowing early detection and
correction of errors including direct checking against source documents
• Conduct electronic queries and responses at sites
• Optional paper data entry (PDE) with traditional CRFs, e.g., if a particular site
does not have internet access or data entry personnel available
• Comprehensive programmed data validation and edit checks on all study data
• Central database management with database located at CRO facilities
• Real time access to data at sites and from central data management location
• Sponsor access to study status and reports
The EDC system has been developed by professionals with backgrounds in
Information Technology, Re