Data Management

Bioforum’s Clinical Data Management team is fully committed to providing high-quality and reliable services using the industry’s leading technology designed for quality data capture.

We manage all aspects of your data – from study startup to submission, and closely collaborate with clinical teams ensuring they meet the timelines and milestones of their trial.

Bioforum is a data-focused CRO, therefore we strongly standby the industry standards by complying with Good Clinical Data Management Practice (GCDMP) and Clinical Data Interchange Standards Consortium (CDISC).

Bioforum’s Clinical Data Management Support Services:

  • Data Management Plan Development
  • Clinical Data Review and Query Management
  • External Data Transfer and Reconciliation
  • Adverse Event, Concomitant Medication, and Medical History Coding
  • SAE Reconciliation between Safety and Clinical Databases
  • Development of Custom Status Reports
  • Database Lock Procedures

Bioforum’s Clinical Data Management team is fully committed to providing high-quality and reliable services using the industry’s leading technology designed for quality data capture.

We manage all aspects of your data – from study startup to submission, and closely collaborate with clinical teams ensuring they meet the timelines and milestones of their trial.

Bioforum is a data-focused CRO, therefore we strongly standby the industry standards by complying with Good Clinical Data Management Practice (GCDMP) and Clinical Data Interchange Standards Consortium (CDISC).

 

Electronic Data Capture

We are here every step of the way to get our clients clinical trials submission-ready.  By combining our clinical expertise and data management analysis we enhance the design implementation and use of Electronic Data Capture (EDC). We face challenges and complexities of collecting patient data while implementing data standards and ensuring reusability for subsequent studies.

Our Services Include:

  • eCRF Design
  • Database design and validation
  • Edit check programming and testing

Supported Technologies

Bioforum is a certified Medidata Services Partner. We implement and leverage the industry-leading EDC platform (Rave) to support the growing needs of trial managers and study teams. Medidata fully optimizes the data capture process and increases site satisfaction and efficiency by eliminating redundant systems and processes, which decreases trial risks and improves the quality of your trial’s data.

Key Benefits:

  • The industry’s gold standard for EDC (95% of pharma companies run their clinical trials on Rave)
  • Compliant with global regulatory requirements, including 21 CFR Part 11 e-signatures
  • Configurable workflows and security permissions for data entry, review and approval
  • Easily manage mid-study changes