Clinical Study Initiation / Project Management
After your medical device clinical trial strategy is developed and your study endpoints are in place, MDCI will assist you with a full range of study initiation services. MDCI will oversee day-to-day study activities, giving you confidence that all of the relevant data is captured, collected, and interpreted to support your study goals. Your project manager will work with you to:
- Identify and qualify the best study sites and investigators for your medical device
- Conduct pre-study qualification visits to assess your sites
- Prepare your team and support you during initial meetings with the FDA and other regulatory bodies to introduce your medical device and negotiate your pre-clinical trial and clinical trial test plans
- Prepare your study materials, including an appropriate study protocol, Case Report Forms (CRFs), and informed consent documents
- Prepare any necessary documentation for IRB and/or Ethics Committee approval
- Conduct pre-investigational visits to train the clinical trial site staff on the protocol, study materials, applicable regulations and Good Clinical Practices for your medical device
You will receive routine reporting and communication as your study progresses to keep you apprised of data accrual and data quality on a site-by-site basis, and to keep you and your study team on track.
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
The expertise and knowledge that MDCI shared truly helps us accomplish our mission of helping U.S. companies increase their export sales.
- International Trade Specialist at US Department of Commerce