Our Experience as a Dedicated CRO
We believe that MCRA's heritage of combining its integrated services in clinical trials has created a unique system including clinical research, regulatory, reimbursement, compliance and specialized therapy expertise. Whether you decide to utilize MCRA for one component or the full spectrum of medical device CRO services for your trial, MCRA will work hand-in-hand as part of your team.
Comprehensive Clinical Research Services
Our global medical device CRO enables 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 regulatory 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. As your clinical trial organization and well-established medical device CRO, we identify clinical study sites based on our close relationships with clinicians practicing around the country to maximize the clinical studies' success rate.
- Improved clinical study success rate
- World-class regulatory integration
- Optimized regulatory approval times
- Expert monitoring and query management
- World-class clinician/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.
With more than 150 years of combined experience within our organization, we stand as the leading privately held diagnostics, biologics and medical device CRO and advisory firm. We have offices in New York City, Washington, D.C., Hartford, CT, and Tokyo, making us a global leader in this space with more than 1,000 clients around the world. Whether your organization is struggling with regulatory issues, quality assurance, compliance, or another concern related to the medical device product lifecycle, our representatives have the experience and expertise needed to help guide you to a successful launch.
Our ability to combine integrated services during the clinical trial phase means we offer a proprietary system and a unique 360-degree perspective. We have experience across a broad spectrum of therapeutic specialties, from orthopedics to digital imaging. For example, we have expertise in helping clients develop clinical trials for devices ranging from artificial hearts to stem cell therapies to surgical instruments. It is no wonder that organizations throughout the healthcare industry, from global leaders to startups, turn to us to provide them with the guidance and understanding they need to gain a foothold in the marketplace and achieve the most successful start for their new product.