Clinical Research

Clinical Development Planning & Strategy

Starting right with a well-thought clinical development plan

A well-thought-out clinical development plan is a strategic roadmap that outlines the key steps and considerations for conducting clinical trials and gathering the necessary evidence to support the development and regulatory approval of a new medical product. It serves as a comprehensive guide for successfully navigating the entire clinical development process.

Challenges

Designing and implementing a global integrated clinical development plan to ensure a smooth transition to marketing authorization and commercialization.
Navigating the different regulatory frameworks and requirements in a global environment.
Having an overarching development plan integrating nonclinical development plus CMC in alignment with clinical development.

What we offer

Each clinical development plan is unique and we adapt strategies to fit the unique characteristics of the drug, target population, and the therapeutic area.

Protocol Development: We assist in developing patient-centric study protocols, ensuring they align with regulatory requirements and scientific objectives.
Feasibility Assessments: We conduct feasibility assessments to determine the suitability of sites and patient populations for clinical trials, helping to optimize trial design.
Regulatory Strategy: We help to navigate the complex regulatory landscape and plan for successful global clinical trial submissions.

Why work with us?

F.A.Q.

What are the key components of a clinical development plan?

Clinical development plan (CDP) is a strategic document that outlines the key steps necessary for assessing safety and efficacy of a product to bring it from very early investigation in human up to commercialization considering the targeted population & positioning of the product. It is applicable for any type of product such as drug, cell and gene therapies, medical device or digital therapies. CDP provides a roadmap for navigating in the complex landscape of clinical development, regulatory pathway detailing key milestones, timelines, and resources required at each stage.

A typical CDP outlines the evidence generation plan integrating medical, scientific, regulatory, payer environment and patients’ perspectives to which the product is subjected. As core part, it describes clinical trials necessary to assess the medical product and generate robust evidence of safety and efficacy. Elaboration of a CDP requires transversal expertise of regulatory strategist, medical experts, clinical research, market access teams and patient engagement.

This is a living document that is adapted throughout the development process as soon as new relevant data becomes available.

How is clinical development plan revised with the progression of the product development?

Clinical development plan (CDP) is a dynamic document that is revised upon availability of new data. These modifications can come from different sources, such as:

continuous analysis of safety and efficacy data from ongoing clinical trials. Assessments of risks might significantly influence the implementation of risk mitigation strategies;
interactions with regulatory agencies;
competitive landscape or scientific knowledge changes: emergence of new therapeutic option can drastically influence the clinical trial design and conduct (comparator, endpoint, PROs, sample size);
patients expectations/interview/survey to understand the unmet need, the burden of disease, the patient journey;
budget and resources considerations.

Clinical Development Planning & Strategy

Starting right with a well-thought clinical development plan

Challenges

What we offer

Why work with us?

Patient Engagement Explained: Insights from a Patient, a Patient Association and a Pharmaceutical Company

F.A.Q.

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