CLINICAL RESEARCH & DEVELOPMENT:
Clinical Development Plans
The clinical development plan describes the pathway for a company to translate the goals of an initial product profile into the clinical studies that will define the final indications and labeling for the product. The plan is a living document that is updated regularly to reflect new data.
For small companies, a well considered clinical development plan shows potential partners and investors that management has worked hard to de-risk its development program.
Protocols for Clinical Research
The clinical protocol operationalizes the clinical development plan.
Zymo Consulting Group has experience in the development and implementation of clinical protocols from “first-in-human” through more extensive Phase 3 studies.
An excellent protocol has these characteristics:
• A well defined patient population
• Clearly defined and well understood objectives and endpoints
• Precise and relevant statistical considerations at every step
• Thoughtful decision-making concerning the blinding and stratification of treatment groups
• Intelligent data collection/capture targeted to achieve the study’s goals
• Impeccable attention to regulatory compliance issues
Zymo Consulting Group knows that giving the time to do it right the first time is the most efficient and cost-effective approach to a clinical study.