Clinical Trials
Regulatory Insight, Inc.’s clinical division specializes in the design, execution, monitoring and outcomes analysis of pilot studies and pivotal clinical trials to support regulatory submissions for new medical devices or indications for use. Regulatory Insight has successfully managed clinical studies in both the
Specific à la carte clinical trial services offered by Regulatory Insight include:
] Development, design and writing of a clinical study protocol, informed consent form
and case report forms.
] Submitting the completed study protocol to the FDA for a pre-IDE review and
subsequent negotiation with the FDA to resolve any issues with the study approach.
] Identification of a suitable US Institutional Review Board or European Ethics Committee
for submittal of the protocol for IRB/Ethics Committee approval.
] Recruitment, attainment of IRB/Ethics Committee approval and training of study
Principal Investigators.
] Management and monitoring of study progression to assure compliance to the protocol,
IRB/Ethics Committee requirements and US FDA/Health Canada/EU MDD requirements.
] Remote and on-site auditing of clinical study compliance.
] Study database design, data entry and statistical analysis and interpretation of study
outcomes.
] Compilation of the final clinical study report and preparation of the study outcome
results to support a submission for regulatory approval.
Please contact us to learn more about how Regulatory Insight, Inc. can help your company to design and execute a successful clinical trial.
