Clinical Data management
Our clinical data management team is committed to providing efficient and high-value services using the industry-leading technology (Medidata’s Clinical Cloud) designed for quality data capture. We efficiently manage all aspects of data from study startup through closeout while closely collaborating with clinical teams to meet the timelines and milestones of a sponsor’s trial.
Being a data-focused CRO, we put emphasis on allowing efficient and accurate data capture and timely completion of the clinical database. We adhere to industry standard by complying with Good Clinical Data Management Practice (GCDMP) and Clinical Data Interchange Standards Consortium (CDISC) standards.
Bioforum’s data management support services include:
- 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
Electronic Data Capture
By combining clinical expertise and data management considerations, we enhance the design, implementation and use of Electronic Data Capture (EDC). We address the 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
Bioforum is a certified Medidata Services Partner. We implement and leverage this industry-leading EDC platform (Rave) to support the expanding needs of trial managers and study teams. Medidata Rave optimizes the data capturing process and increases site satisfaction and efficiency by eliminating redundant systems and processes, and decreasing trial risk by improving the quality of your data.
- 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 managed mid-study changes