The PK scientist’s data pipeline handles a range of raw data types, including SAS, R, and other formats from multiple partners. This is particularly critical in complex trials with substantial data volumes. Effective data compliance management is vital, involving tailored compliance for exploratory studies and full compliance for clinical studies adhering to FDA’s Title 21 CFR Part 11 regulations.
Certara’s cloud application Integral offers comprehensive functionality for PK scientists to oversee the data lifecycle. This includes support for both non-GxP studies, where eSignatures are not mandatory, and GxP studies, where eSignatures are a requirement. In this webinar, attendees will learn how organizations can leverage Integral to optimize the management of pharmacokinetic data sets and significantly streamline PK scientist workflows.
Webinar Agenda:
– Brief Overview about Integral
– Introduction of enhancements and new capabilities with the release of Integral 23.10.1
– Integral Demo
– Q&A with Certara expert Michael Clifton
