Rewriting the Rules: What the 2025 SyncUp Summit Signals for Clinical Development
Explore key insights from the 2025 SyncUp Summit from Syneos Health, including protocol design trends, enrollment strategy, AI integration and leadership development shaping clinical trial performance.
BOSTON, MA—Clinical development is under measurable strain—from protocol inflation and enrollment volatility to workforce pressure and capital discipline. At the 2025 SyncUp Summit, leaders across the clinical ecosystem gathered to move beyond diagnosis and toward accountability.
“When it gets hard, take a minute,” said David Burnham, Senior Vice President and Managing Director of Global Client Services at Syneos Health. “You won’t hear silence—you’ll hear the voices of patients and families saying, ‘don’t give up. What you’re doing matters.’”
That charge framed three days of practical dialogue focused on execution discipline, patient-centered design and the structural drivers of delay.
Join the leaders shaping what comes next at the 2026 SyncUp Summit.
Day 1 | Listening and Learning From Those Who Matter Most: Patients, Caregivers and Sites
Patient Voices Matter: Song, Story and the Power of Representation
Caregivers and patient advocates highlighted the continued disconnect between protocol structure and patient lived experience. Transportation, caregiver burden, financial impact and health literacy remain material considerations. Musician and advocate James Ian, who lives with spinal muscular atrophy, emphasized the importance of recognizing patients as individuals beyond their participation status. The discussion reinforced the need to incorporate patient context earlier in study planning.
Caregiver Voices Matter: A Rare Disease Journey That Sparked a Movement
Caregiver advocacy is increasingly influencing how rare disease trials are designed and executed. Jordana Holovach highlighted how sustained engagement between patient communities, sponsors and regulators can shape protocol decisions, accelerate alignment and improve trial feasibility. In ultrarare indications, where enrollment pools are small and timelines are critical, early partnership with advocacy organizations strengthens trust, reduces friction and keeps development anchored to real-world need.
Site Panel: What Sites Wish Sponsors Knew
Site leaders described ongoing strain caused by lengthy feasibility questionnaires, overlapping technology platforms and unclear escalation pathways. Sponsors were encouraged to simplify systems and strengthen engagement with study coordinators alongside principal investigators. Execution constraints at the site level remain a determinant of enrollment and retention performance.
Rethinking Traditional Trials: Empowering Patients and Accelerating Research Through Synthetic Control Arms and AI
Nasha Fitter, founder of Citizen Health and co-founder of the FOXG1 Research Foundation, challenged traditional assumptions about how clinical data is collected, owned and operationalized. Drawing from her experience as both a caregiver and a rare disease trial sponsor, she highlighted the inefficiencies of repeatedly burdening small patient populations with surveys and duplicative data requests when rich clinical information already exists within medical records.
Day 2 | Forces Shaping the Present: Cost, Investment, Regulation and Policy
Turning Insight into Action: How Leaders Are Cutting Costs, Accelerating Timelines and Easing Burden
Kenneth Getz, Executive Director and Professor at the Tufts Center for the Study of Drug Development, presented updated benchmarking data showing continued growth in protocol procedures, endpoints and eligibility criteria. According to Getz, efficiency metrics continue to decline, with longer activation timelines, recruitment delays and higher screen failure rates.
Post-session workshop discussions focused on drivers of complexity, including conservative risk assumptions, siloed planning and limited early site input. Attendees evaluated approaches to:
- Align procedural burden with scientific value
- Use historical performance data to test feasibility assumptions
- Engage sites earlier in protocol development
- Clarify cross-functional decision ownership
- The discussion centered on improving protocol discipline to reduce avoidable operational risk.
The Investment Landscape: Who’s Feeding and Who’s Cautious?
Capital markets are rewarding operational discipline over ambition without proof. For emerging biotechs in particular, clarity of execution strategy is now central to funding conversations.
The key themes shaping 2025 and 2026 underscore why operational rigor is becoming a financial signal.
Behind the Curtain of Clinical Outsourcing
Sponsors are demanding greater transparency and outcome-based governance in CRO relationships. As Michael Brooks, Chief Operating Officer at Syneos Health, noted, “We bid to deliver, not to win. If success isn’t mutual, it’s not sustainable.” Execution credibility is becoming a differentiator.
Real-World Data vs. Real-World Evidence: Bridging Science, Strategy and Speed
Real-world data is shifting from retrospective validation to proactive design input. Holly Henderson, Executive Vice President of Real World/Late Phase at Syneos Health, described it as “a shift from collecting information to creating connection.” Used strategically, real world evidence exposes hidden barriers, refines inclusion criteria and strengthens protocol feasibility. Paired with clinical judgment, it transforms volume into value.
ICH E6(R3): From Rules to Reality—What Clinical Operations Leaders Need to Know Now
Sessions exploring ICH E6(R3) reframed the guidance as an opportunity, not a compliance burden. Fit-for-purpose quality, proportionality and risk-based planning provide a structure for disciplined decision-making. Case examples demonstrated how applying R3 principles reduced unnecessary procedures, clarified endpoints and improved sponsor–CRO–site collaboration.
Political & Policy Impact on Drug Development: Navigating the Shifting Landscape
Regulatory modernization, AI governance, pricing pressures and geopolitical instability are influencing timelines and adoption patterns. Clinical development does not operate in isolation. Public trust, legislative priorities and media narratives increasingly shape feasibility, diversity and innovation uptake.
Day 3 | Looking Ahead: Innovation, Technology and the Voice and Future of Clinical Operations
Back to Basics vs. Shiny New Tech: The Art (Not Science) of Enrollment Projections
Despite technological advances, nearly 80% of trials still miss enrollment timelines. Root causes persist including feasibility inflation, unrealistic projections and outdated site selection models. Leaders called for deeper integration of real-world data, patient journey mapping and tighter alignment between protocol design and site operations. Optimism is not a strategy.
Agile Science: AI Muscle for Small Biotech Hustle
The role of generative AI in regulatory documentation and clinical reporting in growing. For small biotechs operating with limited resources, AI-enabled platforms are beginning to accelerate drafting of protocols, clinical study reports and patient narratives—reducing manual burden while maintaining human oversight. When applied thoughtfully, generative AI can improve internal consistency, compress timelines and allow lean teams to redirect effort toward strategic execution rather than documentation management.
Fail Fast, Win Faster: Data-Driven Pathways for Biotechs
In a capital-constrained market, assumptions are expensive. Divergent CRO bids, inflated feasibility projections and shifting competitive dynamics require sponsors to validate strategy before execution begins. Leaders stressed the need to interrogate country selection, site mix and enrollment forecasts using integrated trial, real-world and competitive data. Early pressure-testing reduces downstream amendments, protects budgets and strengthens board confidence.
Managing the C-Suite: Who Represents Clinical Ops at the Top?
Clinical operations remains underrepresented at the executive and board level. Panelists argued that those accountable for execution must be embedded earlier in strategic decision-making. Operational risk should not react to strategy but inform it.
Next-Gen Clinical Ops and Development Leaders—DNA of the Future
The closing session focused on talent pipelines and leadership development—from structured mentorship to cross-disciplinary recruitment. Building resilient clinical organizations requires investing in people as intentionally as platforms.
The 2025 SyncUp Summit made one theme unmistakable: execution discipline is no longer optional.
Across sessions, leaders examined the structural drivers of delay, cost and variability—and challenged one another to confront feasibility inflation, fragmented ownership and avoidable complexity head-on.
Clinical development will not be reshaped by optimism alone. It will be reshaped by accountability, earlier patient integration and decisions grounded in operational reality.
Join the leaders shaping what comes next at the 2026 SyncUp Summit.
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