Our Experience as a Dedicated CRO
We believe that MCRA's heritage of combining its integrated services in clinical trials has allowed for us to create a proprietary system. This includes the integration of clinical research personnel, in conjunction with US Regulatory, Reimbursement, and Compliance services and knowhow. Whether you decide to utilize MCRA for one component or our entire offering for your trial, MCRA will work closely hand-in-hand as part of your team.
Comprehensive Clinical Trial Services
Our CRO enables orthopedic companies of all sizes to successfully execute clinical studies by streamlining the clinical trial process through an integrated approach that guides clients through the medical device lifecycle: from pre-clinical testing, to FDA submission, market approval, and post commercialization. MCRA's CRO executes medical device and medical device combination studies including Pre-Market (Pilot and Pivotal IDE & IND) & Post-Market (Registries, Post-Approval, & Retrospective).
Our Integrated Approach
Our integrated approach to clinical study design and preparation allows clients to see immediate clinical trial enrollment. We identify clinical study sites based on our close relationships with surgeons practicing around the country to further improve the clinical studies' success rate.
- Improved clinical study success rate
- World-class U.S. and International regulatory integration
- Shorter regulatory approval times
- Expert monitoring and query management
- World-class surgeon/research site selection
- Furthermore, MCRA crafts a reimbursement strategy that eases the study sites' administrative burden on gaining insurance reimbursement following pre-authorization and appeals process.