Clinical study start-up is a complex process, involving many moving parts, which can sometimes feel overwhelming. Using strong project management skills to follow a clear road-map, with well-defined workflows, can make the difference between costly delays and success. These skills can enable timely study initiation by enabling sites to handle complexities and minimize delays.
“A lot can go wrong during study start-up,” says Jessica Propps, ACRP-CP, Clinical Operations Manager – Regulatory, at Merck, known as MSD outside the U.S. and Canada. “It’s important to understand how to control for these elements, using lessons learned from earlier studies to help avoid future pitfalls.”
“Skills such as time management, risk assessment, and effective communication are vital to study start-up,” states Tamika Harris, Clinical Operations Manager – Regulatory, at Merck. “These project management skills can enable clinical research professionals to implement robust project plans, manage resources efficiently, stay on track with regulatory requirements, and mitigate risks.”
“Sites should pay particularly close attention to the various study-related deadlines they agree to,” adds Harris. “These should take account of predictable sources of delay, such as national holidays and potential staffing fluctuations, to ensure that agreed deadlines are realistic. Back-up plans to mitigate predictable issues can help, along with involving all stakeholders as part of a collaborative study management team. Strategic project management throughout the study timeline can help identify pitfalls and avoid last-minute issues.”
Project Management Skills for Accelerating Study Start-Up
Join Jessica and Tamika at ACRP 2025 [April 24-27; New Orleans, La.], where they will help attendees learn how project management techniques can streamline the clinical study start-up process and provide practical tools to improve efficiency. View complete schedule.
“Having a thorough understanding of the nuances of institutional rules is also important in identifying potential problems and resolving them,” notes Propps. “This can help avoid predictable delays due to elements such as investigator conflicts of interest. Analyzing a site’s historical study timelines can help with goal-setting and prediction of future timelines. Various tools are also available to optimize sharing of documents between stakeholders, including dashboards and centralized platforms.”
“For study materials, it is important not to keep reinventing the wheel,” according to Harris. “It is more efficient to use templates as the basis for the site information pack, and to take advantage of previously-negotiated language for budgets, contracts, and informed consent forms. Finally, active communication between all stakeholders is essential, with an ultimate goal of streamlining operations so that sites can focus on patient care.”
Edited by Jill Dawson