RCRI provides clinical “CRO” research and much more!

Most people think of a "CRO" as a pharmaceutical company service provider or as a purely clinical organization conducting clinical cro research. The Regulatory and Clinical Research Institute (RCRI) is unique. Unlike many Contract Research Organizations, RCRI offers a full range of regulatory and clinical CRO research and contract services to the Medical Device, Biologics, IVD, and combination product industries. These services include experienced and vigorous clinical trial design and management (clinical CRO research) as well as expert services for the following phases of product development and product lifecycle:

Regulatory Affairs
Clinical Trial Design and Management (a.k.a. clinical CRO research)
Clinical Database Development
Quality Systems and Compliance
Biostatistics
Reimbursement Analysis and Assessments
Health Economics Outcomes Research
Venture Capital Due Diligence

Medical Device, Biologics, IVD, Combination Product Experience

Good regulatory and clinical CRO research needs experienced consultants. RCRI experts have 18-25 years of industry-specific experience per consultant with senior consultants averaging more than 25 years of experience per consultant. Our regulatory and clinical CRO research staff members have gained their experience working at small and large medical device companies, as well as conducting clinical organization research and clinical “CRO” research. We have assisted more than 300 companies worldwide with specialty products including:

Medical Devices
In Vitro Diagnostics (IVDs)
Biologics
Combination Products

RCRI Regulatory experts are true medical device, IVD and Biologics experts who are experienced working with the FDA and OUS regulatory bodies. Typical regulatory assistance includes:

Regulatory strategy development
FDA negotiations
Regulatory submission development including
- PMA
- 510(k)
- IDE
- BLA
- IND
- NDA
- HUD
- HDE

If you are looking for a full service regulatory and clinical research organization or a clinical CRO to assist with your product development or approval, you have come to the right place. RCRI is a unique medical device CRO with a vast amount of experience in many therapeutic areas including but certainly not limited to:

Cardiovascular
Orthopedics
Spinal
Neurology
Wound Healing
Infection Control
Ophthalmology
Oncology
Respiratory
Imaging
Gastroenterology
Dental
Urology

Please contact us to discuss how we can assist you with your reimbursement for your product. Complete our Request for Proposal form on our website's home page, send us an email, or call Juli Denny, Vice President of Business Development at 952-224-2263 for more information about how our regulatory and clinical research organization professionals and other staff can assist you.

RCRI® RESOURCES