Complexity of protocols have increased over the last few years due to the adaptive and distributed nature of clinical trials – and this demands state-of-the-art clinical data management systems and services to simplify study design, conduct, discrepancy management and compliance.
Why Clinical Data Management Services?
Collecting, storing, and curating large amounts of scientific data is important for regulatory compliance. Greater aggregation of data, and its reuse, not only reduces the cost of clinical research significantly, but also accelerates the drug development process.
Specialized clinical data management services can enable the following:
- Ensuring quality and integrity of clinical data
- Compliance to global standards to ensure consistency of clinical data management
- Adoption of specific technologies and best practices in data management
How Can Navitas Help?
Navitas is a Leader for our clients in the life sciences industry, providing services that make clinical research data management processes more efficient and predictable. We understand the intricacies of clinical data management. We have demonstrable capabilities and extensive experience in helping global life sciences organizations with clinical data management processes. Navitas can handle paper-based and electronic data capture (EDC) trial studies across different therapeutic areas and managing data throughout the study life cycle (from study design, conduct, discrepancy management and compliance) as per the regulatory standards.
Navitas recognizes the importance of clinical data management in the drug development process. We offer remote clinical trial data management services in an FDA / EMA compliant secure environment.
Navitas brings you the combined advantage of experienced, professional data management personnel with expertise in medical device, biotechnology, and pharmaceutical therapeutic areas. Demonstrated flexibility to using paper- or EDC-based systems, demonstrated flexibility to using either our internal EDC system or one of your choice. Navitas also provides well-documented and well-maintained Data Management Plans thorough user acceptance testing (UAT) for EDC studies and ensures thorough testing of paper-based databases carried out by strong, motivated project teams
- Development of paper CRF/eCRF Paper CRF printing and distribution
- Paper CRF tracking
- Double-key data entry (paper CRF)
- Clinical database design and set-up
- Deliverable clinical database developed using CDISC SDTM standard
- Data definitions provided in accordance with CDISC CRT-DD specification
- UAT in EDC systems Management of electronically transferred data (Central labs, central readers, etc.)
- EDT specification
- Reconciliation of transferred data against CRF data
- Integration of transferred data into clinical database
- Data validation
- Query generation & resolution
- Review of resolved queries in EDC systems
- SAE reconciliation
- Coding of medical terminology (adverse events, medical history, medications)
- WHO Drug Dictionary
- Clinical database lock
- Clinical database transfers (interim, final)
- SAS datasets
- SAS XPORT transport files
Maintenance of Web-accessed study-specific tracking systems (enrolment, CRF/query tracking)