Expert and Efficient Clinical Trial Design and Execution for Drugs and Devices
Boulder Clinical Science Research is a virtual CRO specializing in clinical trial protocol design and execution over all phases (1-4) of the drug/device development cycle. Boulder Clinical Science combines academic and industry expertise with PhD trained Clinical Scientists and Biostatisticians with a minimum of 20 years of clinical trial industry experience. Clinical Trial Managers and Monitors are seasoned professionals with the scientific and interpersonal expertise to ensure that your trial is executed within your timelines.
Kimberly E. Martin, Phd
Clinical trial design and execution
Efficient and robust clinical trial design for regulatory clearance, reimbursement needs, and publication needs. Our innovative strategic approach will achieve your business goals with optimal return on your investment. Our relationships will help you find the optimal sites for your study.
clinical Evidence and publication strategy
The path to publication ideally starts with scientifically rigorous clinical trial or experimental design, however a prospective approach is not always feasible or affordable. Let us analyze your existing data, find the story that the data supports, and partner with you for peer reviewed publications in reputable journals, or for evidence to support marketing claims, or for alternative indications for your post market product.
Experimental Design and execution
A clinical trial isn't always necessary. We will help you minimize your investment and maximize return by achieving regulatory clearance with bench experiments, biomechanics, finite element analyisis, or pre-clinical outcome data whenever possible.
We have proven experience designing efficient clinical and scientific programs that will move your business forward.
Our regulatory experts have a track record of working with FDA and European notified bodies and of achieving clearance in complex and challenging scenarios.
healthcare economic and reimbursement strategy
We can help you integrate a reimbursement strategy into your product development plan that allows you to obtain meaningful evidence early to maximize reimbursement.
Let us help
Contact us below.