Data Management, Programming, and CDISC Dataset Creation

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.

Our specialized biostatistics, data management, and programming teams have exceptional experience and expertise when it comes to handling clinical data, specifically in compliance with CDISC standards. Many clients approach us to perform their PK/PD analysis on data from a study that has already been completed and the database has been locked. We can provide data management services before and after conducting a study.

Allucent is unique in that we have the capacity to execute full CDISC projects, including the 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. 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 our pharmacometricians/modelers to ensure that decisions being made in data management align with the goals of the project as a whole.

Data Management, Programming, and CDISC Services:

• Bioequivalence/Bioavailability
• CDISC Dataset Generation
• Clinical Research Monitor Training for PK/PD Issues
• Concentration-QT Dataset Generation
• CRF and Database Structure Review for PK/PD Data
• Database Build (Prior to Study)
• Dose Proportionality Assessment
• Exposure-Response Dataset Generation
• 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
• Population PK/PD Dataset Generation
• Protocol and Study Design Review
• Review of Electronic Edit-Checks for PK/PD Data