MCRA's regulatory consulting team works closely with MCRA's Clinical Research Organization (CRO) and data management teams develop a clinical protocol that meets FDA requirements and client needs.
Services We Offer
Clearance or approval of many devices in the US require collection and submission of clinical data. MCRA's regulatory team works with companies to develop a least-burdensome clinical strategy to achieve thier goals.
MCRA has expertise in clinical protocol writing for:
- Retrospective data collection
- IDE studies
- Prospective, randomized trial
- Prospective, non-randomized trial
- Single arm study design with historical or literature based control
- Post approval studies
Our Integrated Approach
MCRA's regulatory consulting team works closely with MCRA's Clinical Research (CRO) and data management teams to develop a clinical protocol that meets FDA requirements and client needs. In addition, MCRA has the reimbursement expertise to ensure that studies are adequately designed to meet future reimbursement needs. MCRA's integrated teams cover all phases of clinical surgeon/research site selection from protocol writing and FDA negotiations to study execution and data analysis.