Pharmacometric Data Assembly

CDISC Data Assembly Services

The FDA has published in December 2014 the binding guidance documents requiring the submission of study data in electronic format, the conversion of clinical data to the appropriate FDA-supported data standard becomes a high priority. The submission of standardized study data enhances a reviewer’s ability to more fully understand and characterize the efficacy and safety of the drug, and complements and promotes interactions between FDA reviewers, sponsors, and data providers.

Simulations Plus data programmers have extensive clinical data management knowledge and experience converting PK-related data into the CDISC SDTM and ADaM standard formats required by the FDA, including SDTM domains PC, PP, DM, EX, their respective supplemental domains, and ADaM basic data structures such as ADPC and ADPP. We stay current with all data standards, and is also involved with developing new CDISC data standards.

Susanne Sardella, Associate Director of Data Management at Simulations Plus, is a member of the CDISC ADaM PK Standards Development team. According to Sardella, “Currently, SDTM standards exist for the derived pharmacokinetic parameter (PP) results, but there is no standard for the non-compartmental analysis dataset that the parameters are based on. The goal of the ADaM PK development team is to provide a basic data structure for these analysis datasets that facilitates common statistical analysis methods, and allows for the necessary traceability and transparency between other SDTM/input data and non-compartmental analysis.”

We take pride in comprehensive preparation and efficient process for converting data to CDISC standards. Policies and procedures are in place to ensure quality of deliverables, and the data programmers have a toolkit full of macros, templates, and snippets to facilitate the conversion time and ensure the validation of the results.

Data Assembly and Programming

At Simulations Plus, not only do we excel in data assembly for population-based analyses, but we’re the only company in the world with a definitive niche in the field. Our experience in data assembly is unique and extensive. In fact, between 2001 and 2007, we wrote 40,950 data programs and we are still programming strong.

We take pride in our comprehensive preparation and efficient process for data assembly. We undertake a complete review of the Investigator Brochure, protocols, case report forms, study reports, and literature to develop a thorough understanding of data assembly needs for pharmacokinetic and pharmacodynamic modeling. Throughout the project, we remain in constant contact with you and your team. We also use multiple tools to foster communication between scientists and data programmers.

Why choose Simulations Plus to create your analysis ready data sets for population analyses?

  • Our experience is unique and extensive.
  • Our preparation is comprehensive.
  • Our process is efficient.
  • Our communications are secure and to the point.
  • Our quality is assured.
  • Our reputation is hard-earned.
  • There’s safety in our numbers.
  • Our teams have strict policies and procedures in place to serve as unblinded data reviewers and frequently perform critical data programming tasks and analyses during the execution of blinded trials so that data and modeling results are available for top line results.