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A Clinical Development Plan (CDP) is a description of the scheduled clinical trials that will be carried out in order to assess the safety and effectiveness of a new drug. It outlines the planned development process of a compound (or set of compounds) based on the target product profile (TPP). Its purpose is to take the product down the right path from the start by carefully planning the clinical trial program.
The CDP typically includes a rationale for the development, both scientific and commercial; the prospective patient package insert/summary of product characteristics; the clinical trials plan (trials that will provide data to support the desired claims); the timeline and costs of the trials (ie, strategic planning of the trials); and regulatory considerations.
The CDP and TPP need to be developed early. Describing the TPP can be seen as part of the CDP discussions. The CDP is a complex document and requires input from different functions (marketing, preclinical, production, pharmacovigilance, regulatory, …). Important cross-functional decisions and strategies need to be made in the early stages, as these will have direct consequences on later stages of the program.
The CDP is a living document and needs to be adapted as results of trials become available. The CDP and TPP need to be kept aligned during the development program.
Emtex Life Science medical writers can manage and coordinate the document development process (of new or updated CDPs) and can help to generate a clear, well structured, and coherent document.
FAQ: Clinical Development Plan
What is a Clinical Development Plan (CDP) and what is its purpose?
A CDP is a description of the scheduled clinical trials required to assess the safety and effectiveness of a new drug. Its purpose is to guide the development program from the start by outlining the clinical trial strategy based on the target product profile (TPP).
When is a CDP needed during product development?
A CDP is needed early in development, as it defines the overall clinical strategy, the sequence of trials, the planned claims, and the rationale behind the development. It helps ensure that strategic decisions are made at the beginning of the program and that the CDP and TPP remain aligned as new trial results become available.
What information is included in a CDP?
A CDP includes the scientific and commercial rationale for development, the prospective patient package insert or summary of product characteristics, the clinical trials plan, the strategic timeline and cost estimates, and regulatory considerations. It also integrates input from multiple functions such as marketing, preclinical, production, pharmacovigilance, and regulatory.
How can Emtex Life Science support the preparation of a CDP?
Emtex Life Science can support the CDP process by coordinating contributions from all relevant functions, managing review cycles, implementing comments, and ensuring that the CDP is clearly structured and consistent. Emtex can also help with updating the CDP as new data become available.
Why is professional medical writing support valuable for a CDP?
Professional medical writing support is valuable because a CDP must be coherent, accurately reflect the clinical strategy, and stay aligned with the TPP. A medical writer ensures clarity, logical flow, and consistency, helping teams make well‑informed decisions that influence the later stages of the development program.