Data Management

One-stop service for clinical trial data,
covering from managing clinical data collection
until generating data analysis report
For over 20 years, BIOPHICS has been providing clinical data management services in a wide range of study designs and methodology in different scale from a simple survey, disease registry, to all phases of clinical trials. BIOPHICS Data Management team offers tailored concepts across all key therapeutic areas. We combine experience with technology and therapeutic expertise to ensure actionable outcomes and highest quality of the data we deliver.
We provide clinical data management services for:

 Case Report Form (CRF) design & development
  Data management plan
  Database design, setup, testing & validation
  Edit check programming and testing
  Data entry
  Data validation & query management

  Data integration
  Reconciliation of external data
  Medical coding using industry standard dictionaries (MedDRA® and WHODrug®)
  Database lock & database transfer in client’s preferable format
  Data preparation for analysis

Our staff have broad experience running any type of study ranging from small studies to the world’s largest HIV vaccine trial with more than 16,000 volunteers, handling more than 1.5 million CRFs collected during the 7-year study period.

BIOPHICS maintains the primary database of every study in the regulated system compliant with the 21 CFR Part 11. Our data management process follows international standards and guidelines including Good Clinical Practice (GCP) and Good Clinical Data Management Practice (GCDMP). We are a member of Society of Clinical Data Management (SCDM) and a gold member of Clinical Data Interchange Standard Consortium (CDISC).

Validated Data Management System
& Regulated Environments :

• 21 CFR Part 11 compliant
• Clinical Data Interchange Standard Consortium (CDISC gold membership)
• Standard Data Tabulation Model & Reporting
• Standard MedDRA coding & ConMed coding
• Customized computerized system for clinical study management; e.g., AE alert, on-line X-ray image cross-checking

“We” turn data into actionable wisdom