Many pharmaceutical companies have started to look at their processes through the lens of valued, external partners. While companies will continue to evaluate the effectiveness of their external partners, many are increasingly looking in the mirror to see at what kind of partner they are to work with.
The beginning of the year is always a good time to take a look ahead at the trends most likely to impact the industry in the coming months. One area that is changing quickly, and which promises to impact clinical trials in the coming years, is biopharma. I recently spoke with Jim Esinhart, CEO of Chiltern, about some of these trends, including study protocols, big data, mergers, and new technologies.
One of the goals of CDER (The FDA’s Center for Drug Evaluation and Research) is to foster patient-focused drug development. As part of that effort, the agency has published a compendium of clinical outcome assessments (COAs) to promote the use of patient-focused outcome measurement in the drug development process.