Clinical Research and Trial Support

Our team works closely with principal investigators and study teams to bring high-quality clinical trials to IU School of Medicine.

Our process includes:

• Feasibility Assessment
  Collaborate with investigators and study coordinators to evaluate protocol feasibility within our site capabilities.

• Budget and Contract Negotiation
  Partner with our finance and contracts manager to develop and negotiate competitive and accurate trial budgets and contracts.

• Study Activation and Execution
  Assign and coordinate with staff to ensure smooth trial startup and execution.

• Ongoing Support
  Troubleshoot and resolve issues as they arise throughout the study.

The regulatory and complicance team offers expert support to help you navigate IRB processes and ensure ongoing compliance.

Regulatory services for all trials:

• Protocol and consent form development.
• Organizing essential regulatory documents and binders.
• New coordinator onboarding and training.
• Protocol revisions, renewals, and amendments.
• DSMB report preparation.

Human subjects and IRB submissions:

• Guidance on IRB submissions and amendments.
• Monitoring visits and audit preparation (IU IRB and FDA).
• Audit response and Corrective and Preventive Action Plans (CAPA).
• Prompt reporting assistance.
• Collaborative Institutional Training Initiative (CITI) and Conflict of Interest (COI) compliance monitoring for faculty and staff.
• Site initiation visit support.
• General questions about IRB or regulatory compliance.

Our clinical research spans a network of leading hospitals and specialized facilities, supporting studies for both adults and children. From investigational drug services to dedicated research centers and biobanking, we provide the infrastructure and expertise needed to advance discovery and improve patient care.