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CRO Services

Data Management for Device Studies

Through selected service providers, DLC offers electronic data capture (EDC) and paper based solutions with all documentation and functionalities required to comply 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 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
  • 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

Please contact us for further information or assistance.