Changing the Game in Drug Development

At Certara, we are innovators, dedicated to helping our clients develop new therapies and target unmet medical needs, expand existing therapies to other subpopulations, communicate scientific information in the language of regulatory success and market access, balance risk-benefit profiles, differentiate therapies from the competitive landscape, and unlock millions of dollars in R&D savings.

Value-focused Drug Development Strategies of the Future

Mounting healthcare and R&D costs, high drug attrition rates leading to decreased numbers of new molecular entity approvals, and growing demands from regulators and payers indicate that a paradigm shift is needed to improve efficiency and productivity across the drug development continuum.

Emerging Issues for Pharma R&D: A Practical Approach for Pediatric Drug Programs

In this webinar, Dr. Barry Mangum from Paidion Research and Dr. JF Marier from Certara discussed how pediatric considerations fit into the overall drug development program. They also made recommendations for addressing issues from both a practical and scientific perspective. Anonymized case studies were presented with a review of historical issues with a focus on solutions for today (ie, licensed comparators differences in US and EU, importation issues, and endpoint selection).

Certara’s Best of Blogs 2016

A selection of short essays from our blog, written to empower our customers with modeling and simulation (M&S) and regulatory writing solutions in order to help them solve the toughest drug development problems. Certara staff contributions range in topic from pharmacometrics to systems biology to the growing importance of regulatory writing and sharing clinical trial results.

The Game Changer

Modeling and simulation in drug development could change the commercial and regulatory landscape forever… and can deliver significant business, scientific and clinical value to companies.

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