From a clinical operations standpoint, we understand the most important elements of a clinical study’s success relative to the research site: preparation, personnel, working relationships, and patient population.
Services We Offer
- Project Management
We manage the day-to-day activities to assure we are on schedule and within budget - Data Monitoring Committee & Clinical Events (CEC)
We provide a standard, systematic, and unbiased assessment of clinical data to determine whether it meets protocol - Regulatory
We leverage the data generated through mechanical, animal, or clinical testing, with unrivaled competitive knowledge, to advise or execute the regulatory pathway of your medical device technology - Phase 1 Clinical Trial Experience
We design and implement the trial to determine general safety & undesirable effects of your new device
Clinical Trial Design: Planning for Success
-
Planning is critical in designing any clinical study.
Clinical trial planning is critical in designing any clinical study & MCRA’s team is the preeminent group to partner with.
Key Considerations:
- Quick regulatory submission
- Quick clinical study completion
- Meticulous study designs to lower risk
Along with our specialty clinical services, MCRA also explores opportunities when developing the investigational protocol that may allow quicker time to regulatory submission and clinical study completion.
This results in a meticulous study design preparing clients for a smooth transition into the Clinical Phase, avoiding protocol design and implementation process pitfalls. -
The Impact
- Improved clinical study success rate
- Shorter regulatory approval times
- Expert monitoring and query management
- Proper regulatory development planning
Furthermore, MCRA crafts a reimbursement strategy that eases the study sites’ administrative burden on gaining insurance reimbursement following pre-authorization and appeals processes.
Our Integrated Approach
MCRA's 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.
