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In today’s increasingly complex clinical research environment, sponsors must strike a careful balance between scientific rigor, regulatory readiness, and patient engagement. The goal is not simply to move faster—but to do so with greater efficiency, clarity, and care for the patient journey.
In a recent webinar, Veristat collaborated with patient recruitment partner, SubjectWell, to discuss timely perspectives on how to accelerate trials while maintaining integrity and maximizing impact.
Here are three essential takeaways from that discussion to guide sponsors in building more responsive, inclusive, and effective clinical trials.
1️⃣ Manage Trial Complexity with Proactive, Science-Based Planning
The clinical development landscape has changed dramatically. With the rise of novel therapeutics, rare disease indications, and precision medicine, trial designs have grown significantly more intricate—introducing new risks to timelines, budgets, and regulatory outcomes.
As Patrick Flanagan, CEO, Veristat observed, “The complexity driving today's trial challenges actually reflects our industry's success, as science now enables more targeted, personalized, and novel therapies than ever before. However, these advances demand more thoughtful and coordinated planning from the outset.”
Sponsors are advised to engage regulatory bodies early, leverage real-world data to validate assumptions, simplify eligibility criteria when feasible, and explore adaptive designs to maintain flexibility. These strategies help mitigate mid-study amendments and improve overall timeline predictability. Parallel workflows—for biostatistics, medical writing, and submission readiness—should be mapped during study startup to compress the final stages of development.
2️⃣ Design Protocols That Reflect Both Scientific Rigor and Patient Reality
While regulatory endpoints are essential, successful trial execution also depends on understanding and accommodating patient needs. Rigid protocols that impose excessive travel, time, or complexity often fail to enroll or retain the intended population.
Kim Boericke, COO, Veristat, highlighted this critical balance: “You have to balance the needs of the trial with the endpoints you're collecting. Patients have lives of their own. They have families, they work for a living, and they want to enjoy the benefits of being active in their community.”
A notable example shared during the webinar involved an ultra-rare pediatric disease trial with significant logistical challenges. Due to the condition’s severity and the limited number of global experts, the trial team restructured the study into two phases. The first gathered natural history data via home-based assessments, minimizing patient travel and burden. The second phase incorporated those insights into a more targeted, site-based protocol with flexible support models.
This hybrid design enabled rapid enrollment and over-recruitment in the observational phase, ultimately leading to a more efficient and successful pivotal trial. The case underscores how early collaboration with stakeholders—patients, advocacy groups, and clinical leaders—can help design trials that are both effective and humane.
3️⃣ Strengthen Recruitment and Retention Through Integrated Technology and Human Support
Despite innovation in clinical trial design, patient recruitment and retention remain significant barriers. Sponsors frequently encounter delays caused by outreach inefficiencies, limited site bandwidth, and lack of patient engagement tools.
Dr. Matthias Roos, Director of Scientific Affairs, SubjectWell offered four key strategies to tackle this issue:
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Purpose-built creative and messaging strategies
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Broad patient outreach through digital, database, and advocacy channels
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Companion support services offering live, personalized guidance
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Real-time technology platforms that monitor patient journeys and site performance
When executed in alignment, these components significantly improve recruitment outcomes. One program highlighted in the webinar showed that engaging patients within minutes of their inquiry—and assigning dedicated companions to guide them through the process—resulted in a sevenfold increase in referral-to-consent rates. These systems also enable real-time course correction, identifying and resolving gaps in communication or process before they lead to dropouts.
This level of integration is not only operationally efficient—it reflects a more patient-conscious model of clinical research.
➡️ Turning Insights into Action
Accelerating clinical trials is no longer a function of speed alone. It requires precise coordination, patient-informed design, and adaptive planning across every function—from protocol development to data submission. When sponsors apply science-based strategy, operational discipline, and patient empathy together, they can reduce cycle times, improve engagement, and bring therapies to market faster and more responsibly.
Watch the On-Demand Webinar
To explore these insights further - including the rare disease case study and specific implementation strategies - watch the on-demand webinar now.
Contact Veristat:
Fred Martin
Chief Executive Officer, SubjectWell
Fred Martin brings over 30 years of leadership experience in healthcare, with a passion for building strong cultures, high-performing teams, exceptional customer experiences and technology that meaningfully improves patients’ lives. As CEO of SubjectWell, Fred leads with purpose—driving innovation in clinical trial access and patient recruitment.
Outside of work, Fred is an avid adventurer and lifelong advocate for animal welfare and human rights. Whether skiing, scuba diving, surfing or hiking, he embraces every opportunity to explore the world alongside his husband and their beloved pets.
Outside of work, Fred is an avid adventurer and lifelong advocate for animal welfare and human rights. Whether skiing, scuba diving, surfing or hiking, he embraces every opportunity to explore the world alongside his husband and their beloved pets.
Patrick Flanagan
Chief Executive Officer, Veristat
Patrick Flanagan serves as Chief Executive Officer of Veristat, where he leads the company’s strategy, business operations and financial performance. With a distinguished career spanning consulting, healthcare and software sectors, Patrick has successfully driven commercial growth and international expansion while making significant contributions to global healthcare. Prior to joining Veristat in 2013, he held leadership positions at organizations including A.T. Kearney, Baxter International and Oracle.
Beyond his professional achievements, Patrick is a committed advocate for the rare disease community, having helped raise well over $500K for cancer research through Memorial Sloan Kettering’s Cycle for Survival. He holds a BS from Penn State University and an MBA from Northwestern University’s Kellogg School of Management.
Beyond his professional achievements, Patrick is a committed advocate for the rare disease community, having helped raise well over $500K for cancer research through Memorial Sloan Kettering’s Cycle for Survival. He holds a BS from Penn State University and an MBA from Northwestern University’s Kellogg School of Management.
Dr. Matthias Roos
Director of Scientific Affairs, SubjectWell
With a PhD in Biophysics (summa cum laude) and being a former postdoctoral fellow at MIT focused on virus surface proteins, Dr. Matthias Roos has authored over 15 scientific publications in soft-matter physics and biophysics, earning more than 650 citations and receiving the prestigious Ernst Award from the German Chemical Society. After a fellowship from the German National Academy of Sciences Leopoldina, he transitioned from academia to business with roles at McKinsey & Company and Climedo Health, a clinical trial technology startup, before he joined SubjectWell in 2025. Matthias now combines his scientific and business expertise to achieve lasting impact in the field of clinical trial patient recruitment.
Kim Boericke
Chief Operating Officer, Veristat
Kim Boericke serves as Chief Operating Officer at Veristat and is a member of the Executive Leadership Team, overseeing global operations for clinical trials, projects and programs. With 25 years of clinical research experience, she specializes in clinical trial design and decentralized clinical trial deployment across multiple therapeutic areas and regions. Before joining Veristat in 2024, Kim was COO at Thread and held executive positions at ICON, IQVIA, ClinTrials, INC Research, Duke Clinical Research Institute and i3 Research. A Duke University biology graduate and author of over 15 published articles, Kim actively mentors colleagues, participates in industry forums, advocates for patient centricity and promotes STEM education in her local North Carolina schools.