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Documents

• Trends in Coverage and Reimbursement Policies
• Addressing the Outcomes Studies
• FDA Review Patterns of DeNovo Submissions
• Ethical Issues in Clinical Trials
• Globalization of Clinical Trials

Study Management Services

Regulatory Interactions

Navigating legally mandated regulatory requirements can be complex and confusing.  Boston MedTech CRO provides assistance in a number of areas, including:

• Interaction with national regulatory agencies
• Submission of IRB applications
• Guidance on IRB reporting requirements
• Reporting of serious adverse events