Your PK 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.
PK/PD Data Management
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. These issues are preventable by utilizing Nuventra’s PK/PD Data Fidelity Service, which includes efforts prior to conducting the study and ongoing PK/PD-focused support by pharmacokineticists during study conduct to ensure a robust dataset.
PK/PD Data Fidelity Services
Nuventra’s Pharmacokinetic (PK) and Pharmacodynamic (PD) Data Fidelity Service is targeted towards ensuring that a robust PK/PD dataset is generated from a clinical study. Nuventra has observed a number of pitfalls related to the collection and reporting of PK/PD data and this Data Fidelity Service is designed to share best practices and avoid common PK/PD issues.
Data Fidelity Services include, but are not limited to:
- Protocol and study design review
- PK sampling schedule review
- CRF and database structure review specific to 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