MCRA's regulatory consulting team works closely with MCRA's Clinical Research Organization (CRO) and data management teams to develop a clinical trial protocol that meets both FDA requirements and client needs.
Our Clinical Trial Protocol Writing Services
Clearance or approval of many medical technologies in the US require collection and submission of clinical data to provide reasonable assurance of safety and effectiveness. In some cases, clinical data is needed for reimbursement purposes or for marketing purposes. MCRA's regulatory team works with companies to develop a least-burdensome clinical strategy to achieve their goals.
MCRA has expertise in clinical protocol writing for:
- Single Arm with historical control
- Single arm
- First in Human (FIH)
- Case Series
- Phases 1-4
- Post approval
- Post-Market Clinical Follow-up (PMCF)
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.