Case Study: a global biopharmaceutical company accelerates clinical trial design with Certara Pinnacle 21

Dreaming big with standardization in clinical trial design – one biopharma’s metadata automation journey

The customer, a global biopharmaceutical company focusing on neurology and immunology disorders, wanted to automate and accelerate its clinical study design and build process to gain deeper insights and make more informed decisions faster. They partnered with vendor Certara and its Pinnacle 21 platform to overcome the challenges of manual processes and inconsistent data standards.

Certara implemented its clinical metadata repository (CMDR), part of the Pinnacle 21 platform, to help the company standardize content and automate processes. This solution included creating a new change management process and SOPs. As a result, the company saw an 85% decrease in study setup time and a 50% reduction in the time to complete the first draft review, significantly accelerating its clinical trials.