Clinical Trial Planning

Clinical Trials

Clinical Plan Development

Our clinical trial planning process can help you design a clinical study tailored to your product’s specific needs, to collect data efficiently while meeting all regulatory requirements. The resulting lean, comprehensive clinical study plan can be used to:

• support regulatory submissions;
• estimate project timelines and costs;
• develop the necessary study conduct materials (e.g., clinical trial protocol); and
• request accurate and detailed proposals for study start up and execution (from MED Institute or other service providers).

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Methods for collecting clinical research study data are as varied as the data. Thoughtful clinical study design often means the difference between success and failure, and can make a tremendous difference in the amounts of time and resources spent along the way. With decades of experience in designing early feasibility studies and formal pivotal clinical trials for medical devices and cell therapies, We know how to plan efficient data collection processes that meet applicable requirements and avoid unseen pitfalls that can stop a study in its tracks.

Clinical Trial Protocol Development

Once the clinical study design has been established, the study protocol may be developed. The study protocol is the blueprint for carrying out your study. Writing an ineffective protocol will lead to protocol amendments, which frustrates clinical sites, extends your development timeline, and wastes money.

Our protocol development process involves working in collaboration with clinical experts and other study stakeholders to identify reasonable performance goals, to determine appropriate examinations and procedures, and to define the right patient population. It ensures the clinical study protocol will:

• successfully implement the study plan;
• maintain compliance with all applicable regulatory requirements;
• target collection of data necessary to meet your  regulatory or marketing needs, in a cost-effective way; and
• meet the real-world test (i.e., the study will actually be possible for investigators to carry out in the clinical setting).

A well-written protocol is essential to maximizing efficiency and minimizing risks in gathering the necessary clinical data for your product.