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Clinical Trial Data Management

A clinical trial does not end with successful execution of the study. Of equal importance is the management of the data produced by the clinical research study. The precise, reliable and accurate collection of data organized and packaged to meet current regulatory and industry standards is imperative for every study. BioPharma’s Data Management team is involved right from the outset to ensure that data is correctly managed every step of the way.

BioPharma‘s onsite Phase I Clinical Data Management team is constantly looking for innovative and creative solutions to expand and improve on our processes and procedures that will allow us to exceed client expectations. We understand that Data Management is so much more than simply collecting data electronically. From data collection to data review, query management and mapping under Study Data Tabulation Model (SDTM) standards and CDISC conversion, our goal is to hand over high quality study data to our clients in the most expeditious manner. Learn more about our team.

Schedule a Discovery Call

State of the art facilities. World class leaders. Innovative scientific expertise

BioPharma’s full offering of Data Management services includes: 

  • Data Management Plan (DMP) development
  • eCRF design and development
  • Database Build & Design
  • Data validation specifications
  • Data Management
  • Edit checks Programming & Testing
  • Collection of pharmacodynamics data and review
  • Single or double data entry
  • EDC Training
  • eCRF Completion Guidelines
  • Query Management
  • Third-party data integration
  • Customized clinical data management programming
  • Safety Data Management & Reconciliation
  • Data Export/Transfer
  • Interim Analysis readiness
  • Medical coding (CM, AE, MH)
  • Serious Adverse Event (SAE) reconciliation
  • Customized status reporting and data listings
  • Database closeout and delivery

Our comprehensive CDISC data conversion services include:

  • SDTM annotated CRFs
  • SDTM datasets
  • ADaM analysis datasets
  • Pooled analysis datasets (ISS/ISE)
  • Define.xml metadata and Define.pdf
  • CDISC controlled terminology
  • Data Handling report
  • FDA reviewers’ Guide
  • eCTD structure

Schedule a Discovery
Call Today

Complete the form to schedule a Discovery Call with one of our medical experts to learn how BioPharma Services can be your trusted clinical trial partner.

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