3 Mistakes in Choosing EDC Systems
Dr. Amos Ndhere MD, MS2025-06-13T16:07:53+00:00Choosing the right electronic data capture (EDC) system is critical for the success of clinical trials in Sub-Saharan Africa. An ideal Electronic Data Capture (EDC) system for clinical trials must be secure, user-friendly, and compliant with global regulatory standards such as FDA 21 CFR Part 11, ICH GCP, and GDPR. It should support real-time data entry and validation, audit trails, role-based access control, and integration with other eClinical systems like ePRO, CTMS, and lab data. The system must ensure data integrity through automated edit checks, version control, and secure backup. Additionally, adherence to CDISC standards (e.g., SDTM, ODM) is essential to facilitate data interoperability and regulatory submission readiness. Sponsors of international clinical trials make common mistakes while choosing an EDC for their research. Here are three common mistakes. Mistake #1: Overcomplicating the Selection Process Many sponsors [...]