Through selected service providers, DLC offers electronic data capture (EDC) and Patient Reported Outcome (ePRO) complying with good clinical practices (GCPs) for computerized systems, and with US requirements for electronic records and signatures in accordance with 21 CFR Part 11. EDC and ePRO solutions specifically tailored for small device studies and IVD studies are available.
DLC can provide the following data management services:
- Case report form (CRF) design
- ePRO design
- Development of data management plan
- Database set up including database development and validation and edit checks programming
- Data cleaning and database lock
- Adverse event and drug coding
