Certara’s Synchrogenix Division Named to the 2016 Inc. 5000 List of the Fastest-growing Private Companies in America

PRINCETON, NJ – Aug. 29, 2016 – Certara, the leading provider of decision support technology and consulting services for optimizing drug development and improving health outcomes, today announced that Synchrogenix, its medical and regulatory writing consultancy, has been named to the 2016 Inc. 5000 list of the fastest-growing private companies in America.

Meet Pharma Transparency Mandates & Engage Study Participants

Most clinical study participants want to know the results of trials they participated in. However, few are actually informed. Lack of communication and transparency jeopardizes the success of the clinical research enterprise. In this blog post, I’ll discuss a new model for communicating trial results in lay language with minimum added burden on sponsors and … Continued

Can QSP Save Lives? Lessons from a Trial Debacle

The notion that volunteers could be harmed in a clinical trial is every drug developer’s worst nightmare. Earlier this year, the drug company, Bial, investigated inhibitors of the enzyme fatty acid amide hydrolase (FAAH) in clinical trials as a treatment for pain. Tragically, one person in the volunteer group died, and six patients were hospitalized. … Continued

How to Expedite FDA Approvals of Orphan Drugs

350 million patients worldwide suffer from 7,000 rare diseases, yet only 300 of these diseases have approved treatments. This gap, impacting 95% of rare disease patients, represents a huge unmet medical need. Developing drugs for rare diseases poses a range of clinical, regulatory and commercial challenges. The small number of patients are difficult to identify … Continued

Certara Releases New Version of its Industry-leading PK/PD Phoenix Software

PRINCETON, NJ – Aug. 10, 2016 – Certara, the leading provider of decision support technology and consulting services for optimizing drug development and improving health outcomes, today announced the launch of Phoenix 7.0. Phoenix is the most advanced, intuitive, and widely-used software for pharmacokinetic (PK), pharmacodynamic (PD), and toxicokinetic (TK) modeling and simulation.

FDA’s PDUFA VI Goals Highlight Model-informed Drug Development

On July 15, the US FDA published its goals and commitment letters for the re-authorization of its Prescription Drug User Fee Act (PDUFA) for fiscal years 2018-2022, known as PDUFA VI. The document reflects the agency’s performance and procedural goals to expedite bringing safer therapies to patients.  It also reflects and incorporates the advances in … Continued