A Message from Dr. Shekhar: A Transformational Clinical Research Initiative for Pitt

At the University of Pittsburgh, we are reimagining clinical research to enhance our position as a global leader in academic medicine. We will harness the tremendous collective research strengths of our six health sciences schools to bring novel solutions to clinical care in partnership with UPMC.

To that end, we are creating a collaborative Clinical Trials Office and a Clinical Research Operations office to provide comprehensive centralized support at every stage—from study development to execution, from data management and analyses to publications, and from innovation to implementation in patient care—further establishing Pitt and UPMC as the premier institutions shaping the future of medicine and health care. Together, we will create an environment where our faculty and researchers thrive and, ultimately, patients benefit.

We are committed to significantly increasing our clinical research awards and grants, while building an infrastructure that supports the delivery of impactful patient-centered solutions and products. With this initiative, we will define and streamline key workflows, optimize efficiency, and create a scalable model of clinical research capabilities for our region and beyond. Our approach will reinforce the Pitt-UPMC partnership’s reputation as a premier federally, foundation-, and corporate-sponsored clinical research collaborative that drives innovation and discovery.

These efforts will help to attract top-tier research talent, further establish Pitt and UPMC as leaders in the academic and research landscape, and foster long-term partnerships with sponsors and peers. By optimizing pre- and post-award processes and building a more innovative and unified approach to clinical research, we will ensure continued research excellence and develop new solutions to address medical needs, while advancing health equity.

Introducing the Clinical Trials Office (CTO)

We are excited to announce the establishment of the University of Pittsburgh’s Clinical Trials Office (CTO), which will formally open in January 2025. Specifically, the office will serve as a central hub for coordinating clinical trials activities, ensure compliance with regulatory standards, and provide administrative and operational support to researchers and clinical staff. Moreover, the office will centralize clinical trials activities, such as financial management and subject tracking, and foster dynamic and synergistic partnerships among clinicians, faculty, researchers and sponsors. A CTO website will launch in January.

Introducing the Clinical Research Operations (CRO)

The Clinical Research Operations (CRO) will provide a wide range of outsourced services for clinical research across multiple sites. The Pitt CRO has the capability to manage the entire clinical trial process or specific parts, such as protocol development, regulatory compliance, data management, and analysis. We are centralizing support for multiple site studies and expanding capacity.

OnCore Clinical Trials Management System 

To support clinical research, a new Clinical Trial Management System (CTMS) has been deployed and configured to support Pitt processes. This essential tool is designed to streamline and enhance the management of clinical research operations across our institution. OnCore streamlines clinical trial management by centralizing protocol administration, participant tracking, financial oversight, and regulatory compliance, thereby enhancing operational efficiency and data integrity.

If you would like to learn more about how the CTMS can make your research projects more efficient and compliant, please register for and attend introductory training on OnCore Essentials. This link will provide the training schedule and more information on what you will learn.

Research Personnel-Specific Training: Following the introductory session, formal training programs will begin, featuring specialized tracks and modules tailored to your specific roles and responsibilities in the system. This training will be available to your team as you are onboarding a new protocol. We will share more information about specialty training over the next months.