Taking an average of around eight months, study start-up can be subject to a wide variety of delays that impact study costs and timelines. In effort to reduce this average, HCA Healthcare Research Institute, a site management organization with around 40 sites and 275 open trials, has a centralized approach to reducing start-up timelines.
“We pride ourselves on being a watchdog, for example, by making sure that operational elements of the protocol do not over-burden study participants and lead to withdrawal from the study,” says Jessi Klinedinst, Manager, Regulatory Affairs, at HCA Healthcare Research Institute. “Our team approach is central to success, involving expertise across clinical research disciplines. As a bridge between the sponsor/contract research organization (CRO) and sites, our use of proven quality improvement practices consistently reduces start-up timelines while maintaining quality and compliance.”
“Our focus at the Research Institute is to help our sites and investigators simplify and streamline start-up activities,” says Charita Braker, Manager, Clinical Research Education, at HCA Healthcare Research Institute. “We take a team approach to study start-up, working with the sponsor from the clinical trial lead phase through study activation. Many of our studies reach our target start-up time of 14 weeks. Outliers can typically be identified up-front due to factors such as U.S. Food and Drug Administration study approval delays or the fact that a protocol amendment is underway.”
“Our clinical education team plays a pioneering role in helping sites understand expectations throughout the trial, clarifying specific requirements and moving through challenges with the protocol,” adds Klinedinst. The clinical educator role requires clinical research experience and a high level of clinical knowledge, plus good time and project management skills. The role demands the ability to look at documents, including the protocol and informed consent forms, with a critical eye to ensure high quality, transparency, and continuity.
A Site Management Organization Approach to Study Start-Up
Join Charita and Jessi at ACRP 2025 [April 24-27; New Orleans, La.], where they will explore best practices using specific examples from real-world experiences, including technology use and templates covering communication, trial management, and study and site specifics. View complete schedule.
“The clinical education team acts as the glue between the various different departments,” adds Braker. “Activities include helping sites interpret budgets, providing a coverage analysis to appropriately assign billable items to payers, and offering clinical insights across the whole process. The team is actively involved throughout the study, helping to troubleshoot any issues that arise.”
“This is in addition to the typical start-up tasks involving roles focused on contracting and budgeting, clinical trial management system oversight, and regulatory compliance, where we take a standardized approach,” notes Braker. “Experience at the Research Institute has shown that that delineation of responsibilities helps improve site compliance, data quality, and sponsor/CRO satisfaction. This approach can also achieve benefits at smaller sites.”
Edited by Jill Dawson