Medical Device Preclinical and Clinical Trial Project Management
Medical Device Consultants, Inc. (MDCI) has assisted numerous clients with preclinical and clinical trial project management. After initial design and prototype activities, and as your project proceeds, you will begin to conduct pre-clinical tests and clinical trials and collect appropriate data to support your study endpoints. MDCI can help you to ensure that the appropriate testing is conducted and that your study data is presented in the most appropriate formats for the regulatory agencies and others who will pass judgment on your new product.
Throughout the course of your medical device clinical study, MDCI project managers will oversee day-to-day study activities, giving you confidence that all the relevant data are captured, collected, and interpreted to support your study goals. Your project manager will assist the clinical sites with submissions to the appropriate Institutional Review Boards (IRBs), Ethics Committees, and regulatory bodies to facilitate the approval process, provide routine reporting on study progress to keep you apprised of data accrual and data quality on a site-by-site basis, and keep you and your study team on track with regular communication.
We will work with you to:
- Define appropriate pre-clinical and bench studies
- Develop a clinical trial design, prepare study protocols and study documents
- Identify study sites
- Obtain Regulatory / IRB / Ethics Committee Approvals
- Collect, manage, and monitor clinical trial data
- Perform statistical analysis
- Prepare clinical study report
- Further design and implement your quality system to meet FDA and ISO requirements
Contact Us
Reach our Massachusetts office at 1-508-643-0434, Monday through Friday, 9:00 a.m. to 5:00 p.m. Eastern. Or fill out our contact form and a consultant will contact you directly.
Client Testimonial
I look forward to working with you to complete the entire process and to celebrate the ultimate success of achieving FDA 510(k) clearance. I cannot think of better partners or a better team to achieve this final result!
- U.S. manufacturer and developer of a dental device