Functions R&D

Clinical Development

What is Clinical Development?

Clinical Development teams lead the design and execution of clinical trials. They oversee cross-functional workstreams consisting of several potential areas including biostatistics, regulatory (if the trial is for approval or label enhancement), medical, clinical documentation/medical writing, and pharmacokinetics. Clinical Development is ultimately responsible for the details of a clinical trial including creation and finalization of the final study protocol. They also oversee any amendments to the protocol if needed.

Clinical Development is the key driver of in-human studies which are necessary for regulatory approval starting at Phase I and going through Phase III and beyond (e.g. with LCM and trials for label expansion). They are responsible for ensuring that studies are meeting timelines and remain within budget. In order to do this they work with CRO personnel and potentially other operations colleagues to ensure that patient recruitment is going to track, patient follow-up is being conducted appropriately, and clinical sites are filling out the required case report forms and other documentation. Internally, they are expected to provide updates on timing of studies as they progress.