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.
Nuventra is unique in that we have implemented and developed a specialized data management and programming team. 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. However, our services also include efforts prior to and following conducting a study.
Our data management team has exceptional experience and expertise when it comes to handling clinical data, specifically in compliance with CDISC standards. We are unique in that we have the capacity to execute full CDISC projects, including generation of both SDTM and ADaM domains. This capability is not often found in the industry. In addition, we do not use automated softwares to generate CDISC domains. Our team generates the domains by hand.
The majority of the time, data are not perfect, which produce oddities when trying to create a standardized final product. Our approach ensures that each dataset, CDISC-compliant or not, is created at the highest quality and accuracy given study specific details and the data collected. Additionally, we can ensure that elements are consistent across datasets and the final deliverable is cohesive.
Dataset generation for modeling projects are also conducted by our programming team. Modeling datasets require very specific, manual formatting. Our team works very closely with the modelers to ensure that decisions being made in data management align with the goals of the project as a whole.
Nuventra’s data management team provides non-clinical support in the form of CDISC SEND dataset generation. Additionally, we have growing capabilities in both GLP and non-GLP projects.
Our programmers dive deeply into the data and have diverse backgrounds, which allow us to handle difficult and non-standard studies with ease. 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.
Data Management Services
- CDISC Dataset Generation
- Clinical Research Monitor Training for PK/PD Issues
- CRF and Database Structure Review for PK/PD Data
- Database Build (Prior to Study)
- Dataset Generation for Population PK/PD Studies
- Full CDISC Package Generation
- Interim PK/PD Data Review
- Mock Dataset Generation Prior to Database Lock
- PK Sampling Schedule Review
- PK/PD Data Management Plan Addendum
- PK/PD Data Review Tactics
- Protocol and Study Design Review
- Review of Electronic Edit-Checks for PK/PD Data