Could Study Rehearsals Create A New Standard For Site Readiness?
By Cole Eshbach, senior clinical trial manager, and Carrie Lewis, executive director, clinical program optimization, Keenova
A participant’s first visit should never serve as the first true test of a clinical trial’s systems. Rather, every clinical research site should be prepared and every study be operationally ready before the first participant arrives. Yet clinical research sites are being confronted with increasingly complex protocols and high staff turnover. Burnout harms expertise, and replacing a coordinator can reach tens of thousands of dollars.¹
At the same time, clinical trial sites also face operational challenges that directly affect the successful execution of sponsor protocols. For one, negative online perceptions of clinical trials can weaken potential participant’s trust, intensifying recruitment challenges. If patients do enroll, they may walk out of visits due to delays or system failures, which creates even more strain on sites. Study coordinators often juggle multiple protocols and sponsors, each requiring different systems and workflows. Growing protocol complexity and increasing site burden2 are linked to higher rates of deviations, amendments, extended timelines, and downstream corrections.3
To improve readiness, protocol adherence, and participant experience, let’s give sites the chance to rehearse a trial ahead of their initial study visits. These simulations would allow sites to practice study procedures, navigate protocol tasks, and learn the systems they are expected to master before the first participant walks through the door.
Lessons From Other Fields: They Rehearse
In aviation, pilots train extensively in simulators before carrying passengers. Fire departments drill before emergencies. Orchestras play together before the seats fill. Healthcare teams use structured practice to help reduce errors and improve safety.⁴
Yet in clinical research, where coordinators must navigate multiple digital systems and complex visit schedules, dosing windows, and documentation requirements, the first fully integrated run-through often happens with a real participant. We train, review slides, and complete system modules, but we rarely conduct a full visit across all systems before day one.
The Vision: Clinical Trial Rehearsals
Imagine a future in which investigative site teams can rehearse a study before the first participant is enrolled. This vision emerged from discussions at the Innovation Network Gathering (ING)—a collaborative industry forum focused on advancing innovation in clinical research. The simulation would provide site staff with a sandbox training environment that allows them to walk through each visit across systems such as eCOA/ePRO, EDC, IRT, using practice participants or fictional cases like “Patient Negative One” (Kaye Doiron introduced this term/concept in her 2025 ING Conference presentation titled “Rehearsals Matter! Have a Patient Negative One.”) These rehearsals would focus on the protocol elements that most often create confusion or errors.
An integrated walkthrough would give staff the chance to master system workflows and understand protocol tasks as they prepare for the study. It would also provide clarity on how long a visit will take, helping sites plan schedules and enabling participants to better plan their day with confidence. This could improve satisfaction and supports retention.
The goal of the rehearsal is simple: Build protocol fluency, strengthen staff confidence, reduce early-stage errors, promote efficiency, and create a more engaging participant experience from the very first visit.
Why Rehearsals Matter: Quality, Compliance, And Economic Impact
Rehearsals directly support the industry’s quality and compliance goals while also offering economic advantages.
Risk-based quality management principles encourage teams to identify and mitigate operational risks.⁵ Structured visit walk-throughs would give sites the opportunity to uncover workflow gaps, system issues, and documentation vulnerabilities early in the study life cycle. This proactive preparation could reduce preventable deviations, strengthen documentation, and improve inspection preparedness.
These early improvements could also translate into economic value. Each protocol deviation requires review, documentation, and corrective action. Data queries add rework. Early dissatisfaction among participants or site staff can drive attrition, slow enrollment, and disrupt continuity. Industry analyses consistently show that delays, data issues, and protocol changes create financial and operational strain, which underscores the importance of preventing avoidable errors early.⁶
Small intentional investments in site readiness may offset larger reactive costs. Even modest improvements in first‑visit execution can reduce data‑cleaning burden, lower rework, support retention, and help maintain enrollment momentum.
Clinical Research Stakeholders Weigh In
During discussions, sponsors and solution providers shared several comments and concerns:
- Budget Impact: Start-up and implementation costs would apply. However, the cost of early deviations, rework, and participant dissatisfaction (leaving the trial or exhibiting non-compliance) may already exceed the investment required to support rehearsal environments.
- Data Integrity: Data handling controls and clear sandbox segregation would be essential, like the safeguards already used in user acceptance training and training environments. By testing across multiple systems, it's possible to lower data risk by catching problems before actual data is produced.
- Vendor Engagement: Solution providers are key partners. Early adopters could differentiate themselves through improved usability, stronger site support, and a visible commitment to delivering innovations that help site teams use their platforms more effectively.
- Site Capacity: Sites consistently express a desire for smoother first visits and training that reflects actual workflow. This is especially important given high workload, staffing constraints, and frequent turnover.⁷
Successful implementation requires coordination across sponsors, vendors, and sites. Our industry needs to align development timelines to ensure sites have a sandbox environment early to practice visits across systems, which will minimize avoidable issues before the participant arrives.
How To Make Clinical Trial Rehearsals A Reality
Progress will come from intentional steps that we take together. We invite sponsors, solution providers, and sites to join us in the following actions:
- Form cross‑industry working groups or a consortium to define and share standards and best practices.
- Launch focused pilots with willing sponsors and sites to test impact, measure outcomes, and refine the approach.
- Partner with technology vendors and leverage current technology to begin multi‑system sandboxes and accelerate new solutions.
- Advance conference dialogue to refine and promote the model and to align the ecosystem around practical next steps.
The most valuable push will be from trial sponsors willing to lead. Just a handful of sponsors can catalyze the shift and help the entire ecosystem embrace innovation, collaboration, and a shared commitment to improving research and participant outcomes.
Toward A New Standard in Clinical Research
Implementing site rehearsals for clinical studies can improve data quality, enhance the experience of participants, site staff, and sponsors, and ultimately help bring new treatments to patients faster, which is the reason for all of this. It’s a win-win-win for participants, site staff, and sponsors.
An Early Mover: Keenova’s Next Steps
As an industry, we need to take steps beyond intention. Keenova aims to contribute to this effort by advancing practical actions that others can build on. We intend to:
- run a rehearsal with select trial sites using the eCOA/ePRO sandbox to preview patient visits before the first visit with our service provider, YPrime
- provide a sandbox EDC environment for site teams to demo the CRFs that will be used to enter the data with our service provider, Veeva
- implement the visit flow chart for upcoming Keenova studies to provide a picture of the steps/complexity of the visits
- share lessons and templates with potential collaborators and sponsors, which cross-industry working groups plan to discuss at industry conferences
- promote dialogue at conferences to build awareness⁸
- grow cross-industry working groups and cultivate a coalition committed to initiating rehearsals in trials.
- demo reconstitution procedure to ensure confidence in completing this procedure.
This journey requires vision, collaboration, and investment. We welcome other study sponsors and allies who share the goal of strengthening site readiness and improving participant experience. The impact will grow across the industry as we give sites the tools and preparation they need to be successful.
The first participant in a study should not be the first full test of the system. Let us work together toward a future where every site feels equipped, every study starts with confidence, and every participant benefits from research that is as prepared as the treatments it seeks to deliver.
Authors’ note: We recognize the collaborative nature of our work and wish to express our appreciation to Jeff Smith and the ING Innovation Network team. We participated in the ING Innovation Network Gathering, where initial iterations of these concepts were first developed. The encouragement and continued support from this group played a meaningful role in shaping the concept of clinical trial rehearsals and in sustaining the motivation and enthusiasm to advance this work forward. We also thank YPrime and Veeva for helping us make our sandbox environment a reality.
References:
- Association of Clinical Research Professionals (ACRP). Navigating workforce stability in clinical research. ACRP; 2025.
https://acrpnet.org/2025/07/30/navigating-workforce-stability-in-clinical-research - IQVIA. Assessing protocol complexity and its impact on trial outcomes. Durham (NC): IQVIA; 2026. https://www.iqvia.com/blogs/2026/01/assessing-protocol-complexity-and-its-impact-on-trial-outcomes
- Sharma K, et al. Impact of protocol deviations on the clinical study. J Clin Trials. 2023; article PMCID: PMC10267991. https://pmc.ncbi.nlm.nih.gov/articles/PMC10267991/
- Agency for Healthcare Research and Quality (AHRQ) PSNet. How does health care simulation affect patient care? AHRQ; 2023.
https://psnet.ahrq.gov/perspective/how-does-health-care-simulation-affect-patient-care - WCG Clinical. Elevate training to overcome site burden and reduce protocol deviations by 35–50%. WCG; 2025. https://www.wcgclinical.com/insights/elevate-training-to-overcome-site-burden-and-reduce-protocol-deviations-by-35-50/
- Clarivate / Clinical Trials Arena. Revealing the human and business cost of clinical trial inefficiencies for data managers and CRAs. Clarivate; 2025. https://www.clinicaltrialsarena.com/sponsored/revealing-the-human-and-business-cost-of-clinical-trial-inefficiencies-for-data-ma/
- Medix. The dangers of staff turnover in clinical trials and how to minimize it. Medix; 2024. https://www.medixteam.com/blog/the-dangers-of-staff-turnover-in-clinical-trials-and-how-to-minimize-it/
- The concept of Clinical Trial Rehearsals emerged and sharpened through dialogue at the Innovation Network Gathering (2025), inspired by Kaye Doiron’s Main Stage Talk
https://innovationgathering.network/main-stage-talks/v/kaye-doiron?categoryId=68ee9c4283a31912dc2ca08f
About The Authors:
Cole Eshbach is a senior clinical trial manager at Keenova with over a decade of experience across pharmaceutical and contract research organizations. He has supported clinical trials across a range of therapeutic areas, bringing a strong operational and site-focused perspective to trial execution. Cole holds a master’s degree in counseling and previously worked in behavioral therapy, where he focused on improving individual outcomes through practical, human centered approaches. He carries this same philosophy into clinical operations, with a particular emphasis on improving the research site experience, fostering collaboration, and driving sustainable growth within the clinical research industry.
