Clinical

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 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 knows that giving the time to do it right the first time is the most efficient and cost-effective approach to a clinical study.