Clinical Development Planning

A Clinical Development Plan (CDP) is the strategic blueprint that guides clinical studies from pre-IND to full marketing approval, aligning with a sponsor’s objectives. This plan encompasses projected timelines and budget estimates, vital for internal decision-makers to prioritize resources and plan for hiring or outsourcing. Additionally, it serves as a communication tool for investors, partners, and grant applications.

Throughout product development, decisions and actions vary based on factors like resourcing priorities, target product profile (TPP), and competitive landscape analysis. Sponsors engage in CDP development to articulate these factors, design studies accordingly, and mitigate risks, especially in early stages. Early phase clinical study synopsis often integrates with CDPs.

The need and extent of CDPs evolve over time. For instance, a high-level plan is essential in the pre-IND stage, while a more detailed plan may be necessary for early-stage fundraising. A comprehensive plan covering all studies through marketing approval is vital for long-term planning.