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