Data management involves the collection, handling, data cleaning, transfer, and traceability of the clinical data. The data management procedures must be agreed upon beforehand and carefully documented during the clinical study to ensure compliance and integrity of the data.
Data management is crucial for ensuring the quality of the clinical study data and providing traceability that shows the data have been managed according to regulatory guidelines, and the conclusions drawn from the clinical study are reliable and trustworthy.
Data management
Ensuring data quality
There are several user-friendly, 21 CFR Part 11‑compliant electronic data capture (EDC) systems that can be used to build your electronic case report form (eCRF), depending on your budget and requirements. We have experience with a variety of EDC systems, as well as capturing electronic patient-reported outcomes (ePRO), which utilize questionnaires that patients fill out directly on their smart phones.
Data management services include: