Implementation of a Compliant Clinical Data Repository in 21 Days

Certara’s PKS Online enabled PKPD Bioscience Inc to become regulatory compliant and enhanced partnering with pharma companies

PKPD Bioscience Inc™ is a specialized pre-clinical/clinical pharmacology and pharmacometrics contract research organization (CRO) based in Exton, Pennsylvania. They provide computer-based data analysis and modeling and simulation consultancy services to pharmaceutical and biotech companies.

Scientists from PKPD Bioscience Inc perform their non-compartmental and compartmental analyses of pharmacokinetic/pharmacodynamic (PK/PD) study data using Certara’s Phoenix® WinNonlin®. While they appreciated WinNonlin’s comprehensive analysis environment, workflow templates, and its ability to create high quality outputs, they were spending too much valuable time on tedious and labor-intensive management of paper trails associated with regulatory documentation for study data.

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