Clinical Research and Trial Support

Our clinical research team supports investigators through every phase of the research process, from feasibility and budgeting to regulatory compliance and study execution. Whether you are launching an industry-sponsored trial or initiating your own investigator-driven study, we are your partners in clinical research success.

A blue gloved hand holds a testing tube while a pipette injects a sample into the tube.

Clinical Research by the Numbers

Since 2019, our clinical research has been powered by 90 dedicated investigators, advancing care through groundbreaking studies across a range of specialties.

300+

clinical trials conducted

8,000+

patients treated

100+

industry sponsors, including Johnson & Johnson, Boston Scientific, W.L. Gore & Associates and Cook Medical

Jennifer Stashevsky, wearing a protective gown and gloves, prepares a sample at the paraffin machine in the Murphy lab.

Industry-Sponsored Clinical Trials

Melissa Stanley, the director of clinical research, 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.

Email Melissa Stanley

Email the Clinical Trials team

We are registered with many major Contract Research Organizations (CROs) and leading pharmaceutical and device companies. We also meet directly with company representatives to explore new clinical trial opportunities.

To learn more or discuss a potential partnership, please contact our clinical trials team.

Image of a caucasian hand with a pen getting ready to sign an agreement

Regulatory Services

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.

Email Rich Hoffman

Leading Investigators

Breast

Carla S. Fisher, MD, MBA

Professor of Surgery

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Transplant

Chandrashekhar A. Kubal, MD

Professor of Surgery

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Pediatric

Troy A. Markel, MD

Professor of Surgery

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Vascular

Raghu L. Motaganahalli, MD

E. Dale and Susan E. Habegger Professor of Surgery

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Wound

Mithun Sinha, PhD

Assistant Professor of Surgery

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Bariatric

Dimitrios Stefanidis, MD, PhD

Harris B. Shumacker Jr. M.D. Professor of Surgery

Read Bio

Clinical Research Facilities and Resources

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.

Learn more

Meet the Clinical Research Support Team

Troy A. Markel, MD

Professor of Surgery
Vice Chair of Research, Department of Surgery

Email Dr. Markel

Melissa Stanley

Director of Clinical Research

Email Melissa Stanley

Rich Hoffman

Regulatory and Compliance Coordinator

Email Rich Hoffman