Data Management and Biostatistics

Our clinical data management team utilizes our advanced and comprehensive in-house clinical data management CDISC ODM standards-compliant software to ensure auditable GCP quality results. 

biostatsistics  

Our data management services include:

  • Paper-based and web-based trials
  • Electronic Data Capture in full compliance with CFR 21 part 11
  • Blind and independent double data entry
  • Full electronic Audit Trail
  • Computer-generated and fully tracked Data Clarification Forms (queries)
  • Coding terms using MedDRA for adverse events and medical history, WHO-Drug ATC/DDD for medications prior/concomitant, or client’s custom dictionary
  • Automated and manual capabilities for import, export, and interchange of clinical data with other systems
  • Archival to CD-ROM and PDF
  • Reconciliation of safety database vs. study database

Paper-based process:

Our paper-based process implies independent double data entry with a third party referee. Data is collected on paper forms and entered by two individuals, each working independently of the other, into two separate data sets. The two data sets are compared by a third person, who reconciles discrepancies. The resolved data set permanently saves as a separate data set, as well as adding to the data stream for that data type.

Web-based process:

Our wen-based process implies that data is entered directly from study sites into electronic CRFs (eCRFs). Error checking during data entry at the sites allows early detection and correction of errors including direct checking against source documents.

Both internal and external audits of our databases verify low error rates. Our clients can be assured that study data is managed in a robust manner. Whether your study requires paper, or web-based data collection, we have the experience, expertise, and tools to manage your data.

Access to online demo version of OCT CDMS is available upon request.