Overview: Capturing Efficiencies By Packaging NDA-Enabling Studies
Celerion has been involved in several hundred studies that back up statements in the “Clinical Pharmacology” sections of approved drug product labeling. This experience provides deep knowledge on various options in study design, as well as considerations for effective study conduct.
Celerion has developed packages of these studies involving the same new drug candidate, often with several studies running in parallel to meet tight marketing submission deadlines. Optimally, the client and Celerion engage in discussions about the possible NDA-enabling package of studies around the time of the Phase II go/nogo decision. The client benefits from the knowledge that Celerion can bring to the planning process as well as from favorable pricing that reflects the efficiencies gained by having a focused team working on several studies for the same drug. Celerion benefits from knowing the priorities of each study in the overall submission plan and is able to plan out and confirm resources well in advance of the work.
Your business development representative can arrange to put you in direct contact with Celerion’s experts.