Site Capabilities — The Hidden Drivers Of Clinical Trial Success
By Chintan Desai, CEO, Stryde Research
Back in 2019, I sat across from a frustrated pharmaceutical executive who had just terminated a promising Phase 3 trial. Despite the sponsor choosing sites with impressive technological capabilities and strong track records, its trial had failed to meet its enrollment targets. This was not an unusual occurrence. After all, according to the Tufts Center for the Study of Drug Development, this scenario affects nearly 20% of Phase 3 trials1. Sponsors have attempted to address this challenge by expanding their pre-study feasibility assessments to include more detailed questionnaires about staff experience, patient databases, and recruitment strategies, yet these enhanced evaluations still fail to capture the nuanced factors that truly drive successful enrollment. Sites, on the other hand, have focused on building technology capabilities to alleviate the problem. After spending 15 years advising pharmaceutical companies on their clinical operations solutions and more than two years as a site owner, I've learned that the success of trials at the site level often hinges on factors that rarely make it onto traditional feasibility capability checklists.
Let's be honest: We've overcomplicated site selection. While everyone talks about technological capabilities and patient databases, the real measures of a site’s likelihood of success are messier and more nuanced. As a part of consulting with a midsize biotech company, I discovered that their best-performing sites weren't necessarily the ones with the most advanced systems. Instead, they excelled at combining basic capabilities in sophisticated ways.
The Real Business Capabilities That Matter
Through dozens of site assessments and performance analyses, we identified several capabilities that truly drive trial success. These aren't the usual suspects you'll find in standard evaluation forms.
Adaptive Resource Management
The old model of dedicated study coordinators for each trial is dying. Smart sites are building cross-functional teams that can handle multiple protocols. One site director I worked with described it as "running a restaurant kitchen" — everyone has their specialty, but they can jump in wherever needed during busy periods.
This flexibility pays off. From my years working with research sites, I've consistently seen that those using this model can manage roughly 30% more trials with the same staff size while maintaining better quality metrics. It's not about having more resources; it's about using them more intelligently.
Financial Intelligence Beyond Budgeting
I recently analyzed the financial models of 20 high-performing studies. The standout finding? Success wasn't linked to higher budgets or better payment terms. Instead, the top performers excelled at understanding the true cost of running each protocol element, which made that study more efficient. Through detailed time-motion analysis of each protocol element, these sites gained insights that allowed them to streamline processes, properly staff activities, and reduce costly bottlenecks that typically go unnoticed.
One site manager shared an interesting approach: Their site tracks "protocol complexity scores" alongside traditional financial metrics. This helps them accurately forecast resource needs and negotiate realistic budgets. These scores are calculated by assessing multiple factors including the number and frequency of study visits, complexity of procedures at each visit, data entry requirements, and patient follow-up protocols. For example, a Phase 3 oncology trial with weekly biomarker sampling and complex eligibility criteria might score 8 out of 10, requiring 40% more coordinator time than a simpler Phase 4 study scoring 5 out of 10. Based on my experience, using similar methods at sites causes 80% fewer budget overruns compared to others.
Quality As A Business Strategy
Here's a controversial take: Most sites approach quality backward. They focus on avoiding audit findings rather than building quality into their operations. The best sites flip this model on its head.
A research director in Boston showed me how they've integrated quality checks into their daily workflows. For example, coordinators complete a real-time checklist during each patient visit to verify protocol compliance, while data entry staff run daily quality reports to catch potential issues before they become findings. Even front desk staff are trained to spot red flags, such as patients arriving outside their visit windows. Rather than treating quality as a separate function, they've made it part of everyone's job. The result? Their query resolution times dropped by half, and they haven't had a major protocol deviation in three years.
Technology: It's Not What You Have, It's How You Use It
After analyzing all the site-level capabilities, I’ve noticed a recurring pattern: Sites often invest in technology without fully understanding how to use it. When evaluating and selecting technology solutions, they usually focus on three core categories — source (data), regulatory (documents), and patient data — but often miss how these systems should interact to create a cohesive workflow. The most successful sites take a different approach.
Other categories bring more value to these core categories: technology integration and human support.
Making Existing Systems Talk Together
In today's digital research landscape, sites often face pressure to adopt the newest technology platforms. However, recent discussions with research site leaders reveal a compelling insight: Success lies not in acquiring new systems but in making existing ones work together seamlessly. "We don't need another system to learn," a veteran site director explained to me. "What we need is for our current systems to talk to each other intelligently."
This practical approach not only proves more cost-effective than purchasing new systems but also leverages the staff’s existing expertise, minimizing training needs and improving adoption rates. As one site director put it, "It's about working smarter, not harder. When our systems communicate effectively, our staff can focus on what really matters — our patients and our science."
The Human Side Of Technology
While cutting-edge technology promises to revolutionize clinical trials, experienced research sites are discovering that the most powerful solutions blend digital innovation with human connection. "Technology should enhance, not replace, the human element of clinical research," says Dipali Patel, MD, investigator and CMO, Stryde Research. Her approach combines in-person visits with personal virtual check-ins by dedicated “patient champions,” staff members specifically trained to build relationships with trial participants, address their concerns, and ensure they feel supported throughout their journey. These champions recognize that sometimes patients simply need a familiar voice asking how they're doing.
Moving Forward: 5 Practical Steps For Sponsors
Based on my experience working with both struggling and successful trials, here are some concrete recommendations:
- Stop treating capability assessments as checkbox exercises. Instead, spend time understanding how sites combine different capabilities to solve problems.
- Look for sites that show operational creativity. During site visits, ask about specific challenges they've faced and how they've solved them.
- Pay attention to how sites handle routine problems. Their approach to solving everyday issues often reveals more about their capabilities than their answers to formal assessment questions.
- Offer technology capabilities to sites but only if you understand how they will integrate with their existing technology capabilities and the human side of the operation.
- The distinction between business and technical capabilities will likely blur further. The winners won't be the sites with the most capabilities but those that best integrate their capabilities to deliver reliable results.
References:
- Tufts Center for the Study of Drug Development. (2023). "Impact Report: Clinical Trial Complexity." https://csdd.tufts.edu/impact-reports
- FDA. (2023). "Quality by Design in Clinical Trials." https://www.fda.gov/drugs/news-events-human-drugs/building-quality-design-and-conduct-clinical-studies-integrating-quality-design-qbd-and-risk-based
About The Expert:
Chintan Desai is the CEO of Stryde Research, where he champions a "process first, technology forward" approach to transforming clinical research operations. With over 15 years of experience in the industry, he has developed deep expertise in building integrated solutions that put sites and patients at the center of clinical research.
As both a strategic advisor and site owner, Chintan brings a unique perspective to clinical research operations, having experienced the challenges and opportunities from multiple angles. His hands-on experience has shaped his philosophy that successful clinical research requires the right blend of people, processes, and technology — with processes leading the way.
At Stryde Research, he focuses on developing practical solutions that enhance site performance while maintaining the human element that is crucial to successful clinical trials.