CDISC data conversion to support FDA submission
In collaboration with partner Innovion, OCS Life Sciences is supporting a European biopharmaceutical company with a submission to the U.S. Food and Drug Administration (FDA). This company is aiming to submit their New Drug Application (NDA) package to the FDA in 2020.
“It’s great to closely collaborate with our partner Innovion, who has extensive knowledge and expertise regarding regulatory submissions“, says project lead Lieke Gijsbers.
The first phase of this project started in the summer of 2018 and served as a pilot to assess OCS Life Sciences’ and Innovion’s capabilities to convert a study within agreed upon budget and timelines. It encompassed the creation of SDTM and ADaM datasets (including aCRF, Define-XML, Reviewer’s Guides) and reproducing over 15 statistical outputs for a single phase II trial. Since the project was delivered following planned timelines, OCS Life Sciences and Innovion entered the second and current phase of this project. It involves the conversion of 19 phase I trials to SDTM, and the conversion of 4 phase II trials to SDTM and ADaM with the reproduction of 15 statistical outputs.
For the conversion of source data to SDTM, OCS Life Sciences utilises its Mapping Engine. This system, designed and developed in-house, powerfully combines the documentation and programming effort of data conversion.
The third phase of this project starts soon and involves the creation of the Integrated Summary of Safety (ISS) in addition to the writing of a Statistical Analysis Plan (SAP) for this ISS. An ISS entails the analysis results which describes the safety of the drug in development, and is required in an FDA submission.
Lieke Gijsbers: “It’s a wonderful experience working in a dynamic team and satisfying to know that our combined effort in this submission can impact the health of so many individuals.”
We plan to deliver the final package in the middle of 2020 and hope this will lead to a successful submission to the regulatory authorities.