Data Management

Our project teams of qualified Trial Designers and Programmers, Clinical Coders, Keyboard Operators, and Data Management Project Leaders specialize in setting up eCRF applications and in managing external high quality Data collection.

Our team has the expertise to evaluate a wide variety of EDC systems and is available to advise sponsor on the best solutions and informs you step-by-step on its progress.

 

 

We offer a complete range of services in the field of Clinical Data Management:

  • CRF Design & Printing
  • eCRF Implementation
  • Data Management Plan
  • Database Design, Set-up and Validation (Clintrial® Environment)
  • Independent Double Data Entry
  • External data loading in various formats (Central Laboratory data, ECG data, PK data,...)
  • Data Reconciliation – Third parties 
  • Medical Review & Coding (MedDRA® , WHO DD®, sponsor dictionaries)
  • Data Validation: Computerized Edit Checks
  • Quality Control
  • Data Review Meeting
  • Database Lock
  • Data Transfer following sponsor specifications (ASCII, SAS®, Clintrial® protocol) CDISC supported
  • SDTM Mapping

Our quality-orientated work assures you the strict respect of deadlines and with a very high level of results.

Biotrial as stringent IT safety standards, we use SonicWALL® firewalls, HTTPS connections, and our internal servers can only be access using Ethernet cable. External audit of our IT infrastructure are frequently conducted.

 

For more information on our Data Management services and to request a product demonstration please contact us: contact@biotrial.com