Like Good Clinical Practice (GCP), Good Clinical Data Management Practices (GCDMP) are based on regulations and guidance. Specifically, clinical research sponsors, principal investigators, and others can refer to the guidelines outlined by the Society for Clinical Data Management and 21CFR Part 11 regarding data management of electronic records.
Our team follows an established process for consistent data and safety management.
We can help you select the right electronic data capture system, build it according to your specifications and work with site monitors to ensure data is entered accurately and in a timely manner. If you have decided to use electronic patient-reported outcomes, such as questionnaires, we can help you manage that process and ensure compliance.
We can also sort, clean and analyze your clinical trial data and assist with database locking as your trial comes to a close.