Data Management

Good inference can only be based on good data. And collecting good data has to be planned properly and executed without fail. Our clinical data management group provides end-to-end database build and data management services ensuring a clean database. After all, the integrity of the statistical inference rests on the accuracy of the data.

  • Study Start – The very first step for us is a thorough review of the protocol before we design the CRFs. We seek statistician’s help in reviewing the subtle aspects so that it is clear what data the analyses will be based on. The database is built in-house with appropriate skip logics and edit checks built in. The study documents such as the DMP, DTs and CCG, are prepared at this stage to lay out the data management plan, handling of the external vendor data and instructions for filling out the CRFs.
  • Study Conduct – We clean the data continuously and share progress reports with the sponsor at regular intervals. At this stage most time is spent on generating queries and resolving them with the sites. The data reconciliation test-runs are often conducted with vendor data at this stage.
  • Study Close-out – We proactively prepare for the study close-out phase. Final reconciliation of the SAE data and the external laboratory data happens at this time. We use statistical software to address these final reconciliations. We also close out queries, seek finalization of protocol deviation list and prepare documents for signature at this point. Final archival of the database happens after the data base lock, and after the team determines that all issues have been addressed.

These are the tasks performed by our data management group:

  • CRF Design
  • CRF Completion Guidelines
  • Database Development and Deployment [we build study databases using a number of platforms]
  • Data Migration
  • Data Review and Reporting Analytics (JReview, Spotfire, Tableau, etc.)
  • Produce submission-ready CRFs
  • Data Management Plans
  • Data Review Plans
  • Query Generation and Resolution
  • Automated Data Validation to Streamline and Optimize Data Review
  • Medical Safety Review Meetings
  • Medical Coding
  • SAE Reconciliation
  • 3rd Party Vendor Data Transfer Specifications and Reconciliation
  • Database Lock
  • Database archival