Your data are crucial. Data is the language through which sponsors communicate information about investigational drugs to regulatory authorities.
All too often during clinical conduct, the importance of data are minimized and overlooked. Or, the nuances of collection, reporting, and querying of data are not fully appreciated by investigational sites.
Many clients approach Nuventra to perform PK/PD analysis on data from a study that has already been completed and the database has been locked. Commonly, we identify issues with such locked clinical PK/PD data that limit the analysis, preclude the ability to fully characterize the PK/PD profile of drugs, or increase the time and cost of properly conducting our PK/PD analyses. Nuventra’s data management services include efforts prior to conducting the study and ongoing PK/PD-focused support by pharmacokineticists during study conduct to ensure a robust dataset.
Our Data Management Services:
- Protocol and Study Design Review
- PK Sampling Schedule Review
- CRF and Database Structure Review for PK/PD Data
- PK/PD Data Management Plan Addendum
- Review of Electronic Edit-Checks for PK/PD Data
- Clinical Research Monitor Training for PK/PD Issues
- PK/PD Data Review Tactics
- Interim PK/PD Data Review
- Mock Dataset Generation Prior to Database Lock
- CDISC Dataset Generation