Clinical Development Plans Preparation

The Clinical Development Plan (CDP)is an essential document in the drug development process because it represents the footprint of the company’s intended clinical program. The CDP is the basis of the General Investigative Plan that is required in Module 1 of the IND/CTD (Section 1.13.9) and which, by US law, must be updated annually. While the CDP serves many essential development needs, it is often under-valued by drug developers. PharmaLex recognizes the long-term value of this essential document, and provides clients with help in its preparation, maintenance, and implementation, as well as its use as a guide for the product’s future.