Electronic Data Capture and Electronic Case Record Forms (EDC and eCRF for Clinical Trials)

Sarjen offers a 21 CFR Part 11 and GCP compliant clinical trials management solution which caters to complete life cycle of BA/BE studies and clinical trial projects. Implemented at one of the leading CROs of the world, the solution enables the CRO to generate and maintain a fully regulatory compliant electronic record. Complete audit trail facility and in-built CRF designing capabilities makes the solution suitable for Phase I and Phase III clinical trials.

BizNET-CTM is a leading EDC solution for top global pharmaceutical companies. With BizNET-CTM, you will benefit from its global capabilities, adaptable framework and exceptional breadth of functionality. BizNET-CTM provides modules for managing trial progress, planning, monitoring activities and investigator information. With the largest user base, installations around the world and years of proven success, you are in the hands of true EDC experts.

Protocol Design

• Reusable Standard Libraries - Activities, Attributes, Validation Rules, CRF designs
• Intuitive CRF design
• Define data validation rule
• Visit scheduling

Application Administration

• Role management
• User management
• Application security
• Audit trail

Data Collection

• Subject management
• Randomization and treatment assignment
• CRF data entry
• Discrepancy resolution
• Site monitoring visits
• Remote data entry via Internet

Data Management

• Data cleaning and validation
• Dictionary coding
• Data export to PDF, Excel and SAS
• Lock data at CRF, subject, site or study

Reports

• Standard reports in PDF format
• Custom reports during implementation
• Supports ODBC reporting tools like Crystal reports

Dashboard

• Study progress
• Subject enrolment snapshot
• Open queries across site
• CRF status

Security

• Authentication: Assurance of identity of person or originator of data, using features like secure login, encrypted password, etc.
• Integrity: Verify integrity and prevent unauthorized modification of data entered
• Authorization: Security roles and privileges, ensure users have the rights to perform certain actions
• Auditing: Track who accesses healthcare information