Data management activities have an essential part to play in clinical trials, especially as trials are becoming increasingly complex. The collection, integration, and validation of high-quality data from a growing array of data sources is an integral part of the clinical trial and supports the success of a trial.
We have 21 CFR Part 11-compliant data management processes which can be used for paper CRFs, EDC-based projects, and rescue studies. Our team of professional data managers has certification in a number of top EDC systems and can work with clients to determine the best fit.
Need a decentralized trial? Our use of technologies to facilitate data management activities using remote consent and other electronic source data as documentation can help. These capabilities can provide adaptable and accurate data capture while maintaining regulatory compliance.
Once we select a data capture system, we build the study database, code the data (AE, MH, CM), review and verify data, and format it for submission to regulatory authorities, successfully working to achieve database lock on or before deadline.
Close collaboration with other functional groups, such as statistics and programming, project management, client and site-based staff, functions to keep data management activities on track with stakeholders informed and involved.
An additional service from this collaboration may come in the form of central monitoring/risk-based monitoring where the process of reviewing aggregate data from the ongoing trial using analytics and visualizations to identify patterns/issues/risks in the data can be carried out.
Data Management Services and Capabilities:
- Case report form (CRF) design/eCRF
- CDASH library of templates for CDISC SDTM mapping
- Database development and validation
- EDC system selection, set up, and training
- Training for User Acceptance Testing
- IRT integration within EDC system for randomizations
- Development of data management plan
- Coding of AEs and MHs using MedDRA, coding of CMs using WHODD
- Quality process for query/resolution/reconciliation
- Technology for handling decentralized monitoring and electronic source data
- Use of dashboard visualizations and available service for risk-based management analysis and reporting