Idorsia Pharmaceuticals Ltd was founded in June 2017 and came about as a result of the acquisition of Actelion Pharmaceuticals by Johnson & Johnson. Transition agreements allowed the company to use legacy systems from the prior company for a period of 18 months. By the time the agreements expired, Idorsia would have to design its own systems landscape.
Many biotechnology/pharmaceutical organizations are in the early stages of developing their risk management process. For the most part, we tend to see this process developing at the clinical trial level. The struggle with implementing these practices solely at the trial level is that it quickly becomes inconsistent and obsolete. Study teams are taking the time to assess risk as it applies to their trial, but the information gained is seldom shared cross-functionally or upward through an organization. It is more of a “going through the motions” type of practice — which is then filed away, never to be utilized again.
White Paper |
By Wayne Bowden and Kurt Gehlsen, Ph.D.,Biorasi
Just as patients have a stronger voice in today’s healthcare marketplace, that voice should resonate earlier in the drug development process. By adopting a patient-centric approach during protocol design and in day-to-day study management, sponsors can expect improved patient enrollment and retention, as well as a cleaner study with definitive outcomes.
CRAs are tasked with making sure all documentation and data is as it should be: current, compliant, and following the study protocol(s). Read how, with cloud-based web and mobile eTMF solutions, CRAs can throw away their spreadsheets and experience process improvements.
Take a closer look at funding strategies for companies launching products for the first time. Does partnering or "going it alone" make more sense for emerging companies? Read the findings of a 2006 to 2015 analysis, including implications for research companies, their potential large pharma commercialization partners, and venture capitalists.
The most successful clinical trials have one thing in common: sponsors never stop looking for ways to improve processes that support the core objective of delivering safe, compliant investigational product to patients, when and where they need it. Learn how one sponsor effectively managed a drug formulation change midtrial without study interruptions or patient impact.