This webinar explored a new version of a 21 CFR Part 11 compliant data repository that significantly improves the clinical pharmacology workflow. A successful drug development program relies on data being centralized in an accessible, understandable, mineable, traceable, and secure location for analysis and interpretation. Provisioning data to scientists in an organized manner with high performance can be a challenge. Certara Integral is a validated and 21 CFR Part 11 compliant software as a service data and model repository utilizing the CDISC data model and Amazon Web Services infrastructure, providing an intuitive solution to this problem.
About Our Speakers
Kevin Trimm is the Senior Director of Product Strategy and Services at Certara. Prior to joining Certara as the Director of Phoenix Technology Services, Kevin worked for 14 years in pharmaceutical research. The majority of that time was spent at Charles River Laboratories where he was the global head of the Pharmacokinetics and Statistics departments. During his tenure at Charles River, Kevin achieved significant growth in these departments through the design, validation, and deployment of both internally developed and commercial software products to introduce efficiency and quality to these scientific services. Kevin later co-founded Montreal Pharmacokinetics Inc., a GLP accredited contract research organization specializing in pharmacokinetic analysis, reporting and consultation that was acquired by Certara in 2018.
This webinar explored a new version of a 21 CFR Part 11 compliant data repository that significantly improves the clinical pharmacology workflow. A successful drug development program relies on data being centralized in an accessible, understandable, mineable, traceable, and secure location for analysis and interpretation. Provisioning data to scientists in an organized manner with high performance can be a challenge. Certara Integral is a validated and 21 CFR Part 11 compliant software as a service data and model repository utilizing the CDISC data model and Amazon Web Services infrastructure, providing an intuitive solution to this problem.
About Our Speakers
Kevin Trimm is the Senior Director of Product Strategy and Services at Certara. Prior to joining Certara as the Director of Phoenix Technology Services, Kevin worked for 14 years in pharmaceutical research. The majority of that time was spent at Charles River Laboratories where he was the global head of the Pharmacokinetics and Statistics departments. During his tenure at Charles River, Kevin achieved significant growth in these departments through the design, validation, and deployment of both internally developed and commercial software products to introduce efficiency and quality to these scientific services. Kevin later co-founded Montreal Pharmacokinetics Inc., a GLP accredited contract research organization specializing in pharmacokinetic analysis, reporting and consultation that was acquired by Certara in 2018.