Services //

Full Lifecycle Clinical Trials Services

The mission of the Clinical Trials Office (CTO) at the University of Pittsburgh is to provide centralized support for Principal Investigators and study teams engaged in clinical trials. By providing a specialized workforce and key resources, the goal of the CTO is to improve efficiency, quality, and the cycle time for activation of clinical trials across Pitt and UPMC.

As a central resource, the CTO has the ability to work directly with a diverse range of sponsors, including industry, federal, and foundational organizations to ensure tailored and efficient support that meets the unique requirements of each trial.

Pre-Award Support

Our support will be during the pre-award phase facilitating access to multiple offices across Pitt and UPMC, serving as a liaison with sponsors and providing investigators with guidance and specialized resources to navigate complex regulatory and operational processes.

CTO Study Management

OnCore CTMS will be used for all studies managed by the Pitt CTO.

Current Services Provided

Budget Development, Service Provider Coordination, and Coverage Analysis

A specialized group of staff from the CTO will centrally support investigators with the process of activation of clinical trials. As part of this initial assessment, the CTO is able to support with all tasks or some of them “as needed”. Please contact the CTO at CTOHelp@pitt.edu for more information and to better understand what type of support you might need it.

The CTO team responsible for budget development, service provider coordination, and coverage analysis is a dedicated group of staff responsible for ensuring study calendars and budgets are developed with accuracy and aligned with the clinical protocol and payment terms, and to support study teams with maintaining financial accuracy and transparency in the management of expenses associated with the studies.

This service is focused on developing and evaluating comprehensive budgets that capture the full scope of trial costs, including potential expenditures and revenues. The team works with service providers across Pitt-UPMC service facilities, core labs and service facilities, conducts detailed coverage analyses to distinguish costs billable to insurance from those covered by sponsors, ensuring compliance with regulatory and contractual requirements.

In addition to crafting and refining budget templates and financial models tailored to individual trials, the team oversees budget performance throughout the trial lifecycle. By addressing variances proactively, configuring and generating reports to support research teams, they ensure alignment with financial goals. Their work provides a robust foundation for informed decision-making and effective resource allocation during the life of the trial.

If you have any questions regarding budget development or coverage analysis, or need support with your study, please reach out to CTOCA@pitt.edu.

Sponsor Budget Negotiations

The Sponsor Negotiations service available for investigators ensures seamless coordination with study teams by managing study budget negotiations directly with sponsors on behalf of Investigators to secure terms that support favorable financial and operational objectives, aligning with both institutional policies and sponsor agreements.

For more information about our sponsor negotiation support, please contact us at CTOBudg@pitt.edu.

Study Expense, Enrollment Tracking, Invoicing Support

The Study Expense, Enrollment Tracking, and Invoicing Support team is responsible for managing the financial transactions of clinical trials, ensuring accurate participant enrollment tracking, and supporting invoicing and financial documentation processes. They provide real-time monitoring and reporting of study expenses to ensure transparency and alignment with trial budgets.

The team supports study coordinators with the process of systematically tracking patient enrollment, ensuring data accuracy and alignment with study projected visits and expenses. Additionally, they facilitate timely and precise billing by offering centralized training and support for the invoicing process, ensuring smooth financial operations throughout the lifecycle of clinical trials.

For more information about our study expense management, enrollment tracking, or invoicing support, please contact at CTOFin@pitt.edu.

Research Finance Billing & Compliance

The Research Finance Billing & Compliance team is dedicated to safeguarding the financial integrity of clinical trials by ensuring all financial processes strictly comply with institutional policies, Medicare rules and federal regulations. Through proactive oversight and meticulous compliance monitoring, the team minimizes fiscal risks and upholds the highest standards of accountability.

Key responsibilities include conducting regular compliance assessments to verify that clinical trial billing adheres to applicable guidelines and managing financial audits with efficiency and precision to maintain fiscal transparency and integrity.

For more information about our research finance billing and compliance services, please contact at CTOFin@pitt.edu.

CTMS Support & Training

The Clinical Trial Management System (CTMS) Support & Training team is committed to ensuring the proficient use of the CTMS, maximizing its utility across all clinical trials. Through ongoing training and responsive technical support, the team enables seamless operations and enhances user confidence in navigating the system.

Key responsibilities include conducting regular training sessions to improve user competency and familiarity with CTMS functionalities. The team also provides prompt technical support in collaboration with Pitt Health Sciences IT to resolve system-related issues efficiently, ensuring optimal performance and minimizing operational disruptions across trials.

For more information about CTMS support and training services, please contact CTOHelp@pitt.edu.