RCRI's Clinical Research Institute conducting leading edge
medical device clinical trials and medical device clinical
research
What is RCRI, Inc?
RCRI stands for Regulatory and Clinical Research Institute. RCRI is located in Minneapolis MN, the home of over 700 medical device, diagnostics, and biotech manufacturers and is the heart of medical device research.
Medical Device Clinical Trial Services
Our clinical research institute is an organization of consultants established to conduct medical device research and medical device clinical trials. Medical device clinical trials need clinical, database, biostatistics, and data management experts. RCRI employs all of these experts under one roof. We also provide extensive regulatory strategy and submission services, quality, biostatistics and reimbursement services as well as medical device clinical trial services.
What else does RCRI, Inc. do?
The Regulatory and Clinical Research Institute does more than medical device clinical research and does more than manage medical device clinical trials. We offer services to medical device firms, diagnostic firms, biologics, and biotech firms who look to supplement their own staff with expert consultants in the areas of regulatory strategy and submissions, quality systems and compliance, biostatistics, and reimbursement. Does your medical device need a regulatory strategy, or do you already have a regulatory strategy that dictates a clinical trial? We are here to help you.
Regulatory Affairs is Medical Device Research?
In addition to our medical device clinical trial research services, RCRI provides a full array of medical device research geared toward medical device regulatory strategy, submission, and approval of you product. How will you get your product approved with the FDA or OUS regulatory bodies? Do you need a medical device regulatory strategy? How about regulatory submission plan? Whether you need approval in the United States, EU, Canada, Japan, etc., RCRI can assist you with your medical device regulatory strategy, submission, and approval needs. Regulatory Affairs consulting is considered medical device research, too.
Quality Systems and Compliance
As you develop a product, regulatory authorities will want to see that you have developed a nice base quality system for product development. Then, as you plan your clinical trial your quality system needs to grow. Finally, once your product is approved, you will need to have a post market quality system and appropriate SOPs in place. All of these quality activities fall under the broad category of medical device research. RCRI will develop a quality system to fit your current and future needs. We can start with the basics and help you grow and your process grows.
Reimbursement
Need a reimbursement assessment as part of your medical device research? Or do you need to know how to obtain reimbursement for your medical device clinical trial? RCRI reimbursement professionals offer Coverage, Coding, and Payments assessments which provide medical device manufacturers with the information they need to strategically obtain reimbursement for their medical devices and medical device clinical trials.
Please see more information about our regulatory and clinical research institute and all of these services on the RCRI home page.
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