How PKS Online Enabled a CRO To Achieve 21 CFR Part 11 Compliance In One Week

A global Contract Research Organization (CRO) used Certara’s Phoenix Connect and Phoenix Knowledgebase Server Online to become regulatory compliant, promote efficient collaboration, and accelerate study turn-around times.

A global CRO’s clinical pharmacology group sought to streamline their data management and analysis workflow. Their clients in drug development were pressing for ever faster turn-around of study results, especially for early clinical trials. The CRO’s internal processes needed to be as efficient as possible, while also meeting the requirements for 21 CFR Part 11 compliance. Complicating matters, the group needed to quickly share data and results among team members distributed across three continents.

The team began searching for a more-efficient new data solution to replace their in-house system of file servers and spreadsheets. As their top priority, the system must support 21 CFR Part 11 compliance with data traceability and change tracking for their clients. It must also be easy to use, and seamlessly integrated into their daily workflow.