Data Management

  • Design and development of both electronic and paper-based case  report forms using CDISC CDASH standards, therapeutic area standards and controlled terminology
  • Preparation of CRF completion guidelines
  • Data management plan creation
  • Generation of the data validation plan (definition of edit checks and checks necessary for medical review)
  • Single or double data entry with third party arbitration of discrepancies
  • Data cleaning/query management
  • Regular quality control through database audits for paper-based studies
  • Import of external data
  • Medical coding according to MedDRA, WHODrug, ATC
  • Preparation of SAE reconciliation Plan
  • Serious adverse event reconciliation
  • Database lock
  • Creation of CDISC SDTM datasets, define-XML v.2.0, reviewer’s guide
  • Database delivery in SAS® transport format, Dataset-XML v1.0, or other formats