top of page

Data Management


Data Management Plan (DMP)

Design and programming of electronic CRF (eCRF)

System Validation Plan (SVP)

eCRF Completion Guidelines (eCCG)

Data Validation Plan (DVP): User Assessment Tests (UAT), design and validation of Edit Checks, Listings-, eCRF Dynamics

Transfer and Validation of external data (Lab, ECG, images, pK data, ePRO), Data Transfer Agreement / Data Transfer Specifications (DTA/DTS)

Data Cleaning: Discrepancy Management, follow-up, review and closure of Queries, manual review of listings -designed as per DVP-

DM Training to Site personnel

Dictionaries: medical terms / medications: MedDRA, WHO-Drug

Safety Data Management and Safety Reconciliation (Adverse Events)

Protocol Deviations

Database Lock

bottom of page