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 2015 and 2020, we wrote over 30,000 data programs and we are still programming strong.
We take pride in our comprehensive preparation and efficient process for data assembly. 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. 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.
In addition, we stay current with all data standards and are involved with a number of industry committees focused on efforts to streamline and harmonize data assembly and analyses-related activities.
Susanne Sardella, Associate Director of Data Management at Simulations Plus, is a member of the CDISC ADaM PK Standards Development team. 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. According to Sardella, “I was honored to be part of the team that completed the new ADaMIG for Non-compartmental Analysis. This standard follows the current ADaM guidance but addresses the unique needs of NCA and allows for traceability, transparency and flexibility to work with the various types of software packages used to analyze PK data.” The team is now turning its efforts to a standard for population PK. PopPk, with its complex analyses presents a formidable challenge but one which the team is eager to complete.
We also have representation on a number of committees focused on R in Pharma, including the R Validation Hub and the Shiny for Submissions Task Force. Nash Delcamp, Clinical Data Programmer at Simulations Plus, is a member on both committees. According to Delcamp, “We have automated processes for creating and maintaining stable R environments with internal and external R packages, and have had successful experiences sharing R code and R packages with our clients and the FDA”.About Cognigen Services