CRO Products and Services

Data Management

Our clinical data management team is using the most advanced and comprehensive clinical data management software available and according to the highest regulatory standards to ensure auditable GCP quality results, and with the required levels of efficiency to keep your drug development and medical device programs on track.

Our data management services include:

  • Web-based e-trials
  • Electronic Data Capture in full compliance with 21CFR part 11
  • Case Report Form annotation and Data Handling Manual
  • Blind and independent double data entry
  • On-demand comprehensive data validation reports
  • Full electronic Audit Trail
  • Computer-generated and fully tracked Data Clarification Forms (queries).
  • Autoencoders for MedDRA, WHO adverse events and
    medications, COSTART, or your custom dictionary
  • Database export to custom ASCII or SAS-AE with
    code list libraries and variable labels
  • CRF scanning
  • Archival to CD-ROM
  • Reconciliation of safety database vs. study database