Study Management Consultation

Expert management consultation services that deliver customized solutions for planning, initiating, and overseeing your projects

What is this offering?

Study management consultation services empower study teams to efficiently plan, initiate, and manage their research study using standard tools and best practices. A consultant can provide guidance on protocol development, Institutional Review Board (IRB) submission, adherence, and study progress through completion. Working with a consultant, the team will discover efficient and practical solutions that align with the specific needs of the project and generate high quality results.

Consultant services are available in, but not limited to, the following areas:

• Management of multi-center clinical projects from protocol implementation through study completion
• Preparation and negotiation of budgets and contracts
• Preparation of multi-site informed consent template(s)
• Management of regulatory document submission
• Maintenance of the operational study file
• Coordination of meetings (i.e., investigator, team, Data and Safety Monitoring Board (DSMB), study coordinator, etc.)
• Editing and distribution documents (i.e., newsletters, reports, safety plans, etc.)
• Subject recruitment/enrollment
• Issues regarding compliance
• Serious Adverse Events/Adverse Events (SAE/AE)

How this advances translational science

Implementing operations that facilitate and support the quality and impact of research