What We Provide: An experienced team of experts who have served on numerous data safety monitoring boards, safety review committees, adjudication boards, and are seasoned medical monitors. This includes the physician chairperson, physicians, and administrator.
Our Approach:
Identifying Medical Needs: The MedSurgPI Team of physicians can cover nearly all indications.
Addressing Key Questions: Our team of physicians have the regulatory, safety, and scientific understanding of your protocol.
The Chairperson: Our experienced physicians have served as chairpersons in multiple studies.
Understanding the Safety and Regulatory Pathway
The safety and regulatory landscape can either accelerate or derail your timelines. Proactively engaging with regulatory bodies and leveraging existing frameworks ensures smoother progression.
Key Considerations:
Do novel therapies require a customized safety and regulatory DSMB strategy?
Developing the DSMB Charter:
Assess the successes and challenges of similar products.
Design a tailored approach to align with your specific safety profile.
Ensuring Alignment and Effective Oversight (key elements)
Addressing the Protocol and Investigator Brochure: ensure the DSMB charter aligns seamlessly with these critical documents.
Biostatistician: Who will understand how to examine interim analysis.
Administration: Ensure a seamless meeting process with an experienced administrator to manage logistics, oversee document disposal, and accurately record meeting minutes.