The solution to persistent startup bottlenecks? Refocusing on site centricity

26 January 2026

Study startup, and specifically, feasibility, site selection and activation, remains one of the most critical yet challenging early phases of clinical trial delivery. Despite technological and operational advances, startup can often be a bottleneck, resulting in delaying the point at which the first participant can be enrolled. These delays can have significant consequences for trial momentum and overall timelines.

While process innovation and digital tools have advanced rapidly, the causes of delay are often rooted not in technology but in human factors. Misalignment, uncertainty and administrative burden at the site level can stall progress just when momentum is most needed. As trials grow in scale and complexity, sites face increasing workload pressures and higher dropout rates. Supporting sites through early, consistent engagement and a robust site-centric infrastructure is now essential for achieving faster, more predictable startup.

Survey says: It’s tough

Recent data reinforces how persistent these challenges are. ICON’s 2025 survey of more than 100 experienced site personnel revealed that startup continues to be one of the most time- and resource-intensive stages of clinical development. It also shows that sites perceive these issues to be worsening under the added pressure of multiple clinical trials with more complicated protocols.

One third of sites reported that time from selection to activation is between two to four months, while 55% indicated timelines of five months or longer. 39% reported longer activation timelines than just two years ago. A staggering 92% cite the contract and budget negotiation phase as the top pain point that delays activation.

Despite operational improvements across sponsors and CROs, these system efficiencies don’t always cross the threshold into sites’ real-world experiences. This gap contributes to both lost momentum and higher attrition, with current attrition rates around 16% in large pharma and 23% in biotech sponsored trials. The rate of sites declining participation pre-selection has also increased, rising from 35% in 2021 to 47% in 2023. Prolonged negotiations, protocol changes after site commitment, and unrealistic enrolment targets are among the most common causes of site withdrawal. Each of these issues reflects a lack of early alignment and effective communication.

Engage early, communicate clearly

Early engagement is one of the most effective strategies for preventing these delays. When sites are involved before final protocols or budgets are locked in, they can provide valuable input that helps reduce rework, improve feasibility, and strengthen commitment. This early collaboration supports mutual understanding and smoother transitions through startup.

Early feedback on protocols can help identify potential operational or feasibility barriers before they escalate and allows for better alignment on resources and capacity planning. The site-level protocol review can also minimise the potential for costly downstream amendments and revisions.

Sites consistently report that clear, two-way communication and streamlined contracting are the most important enablers of efficient startup. Clear communication with sites enables greater transparency and realistic expectation-setting. Yet while 53% of surveyed sites rate sponsor and CRO communication positively, only 5% describe it as excellent. This suggests that even modest improvements in communication quality could have a significant impact on site experience, reducing uncertainty and supporting faster, more efficient activation.

Site support systems and repeat relationships

A site-centric approach to startup goes beyond better communication, requiring smarter systems of support that reduce burden and empower sites to perform effectively. Within well-established site networks, startup is accelerated through consistent operational support and the reduction of administrative burden. Sites under the umbrella of a network benefit from pre-negotiated agreements and standardised templates that significantly shorten contract cycles, while centralised technology platforms enhance visibility and tracking throughout the process. Dedicated liaisons or startup specialists provide continuity, maintaining regular contact and guiding sites through activation with clarity and consistency.

The benefits of structured repeat relationships are measurable. Previously engaged sites typically complete initiation around 9.9 weeks faster on average according to Tufts Impact Report¹ data, while ICON’s Accellacare Site Network, for example, achieves site initiation visits 58% faster than non-Accellacare sites, meaning participant recruitment can start earlier. By investing in long-term site relationships and the infrastructure that sustains them, sponsors and CROs create a stronger foundation for future studies. This approach not only mitigates delays but also helps maintain site engagement and performance in an increasingly competitive and complex clinical environment.

Reframing site centricity as a system-wide advantage

Placing sites at the centre of the trial process delivers benefits that extend far beyond operational timelines. Site satisfaction directly influences participant satisfaction, enrolment, and retention, making site engagement a prerequisite for true participant centricity.

Evidence consistently shows that sites with strong CRO and sponsor relationships enrol participants more quickly and retain them for longer. Prioritising site experience generates positive ripple effects across the entire trial ecosystem: faster activation, reduced attrition, steadier recruitment and higher data quality.

When sites are engaged, informed and supported, their ability to deliver on both operational and participant-focused objectives improves markedly.

Embedding site centricity into startup operations

To transform startup from a bottleneck into a launchpad, site support must be designed into operational processes from the outset. The most successful site-centric frameworks are built on three core enablers:

Alignment and planning: Engage sites during protocol design to ensure feasibility, readiness and realistic expectations.
Data and technology enablement: Use integrated tools to provide transparent, real-time progress tracking and document management.
Dedicated expertise: Maintain ongoing site relationship teams—such as site engagement leads (SELs) and clinical trial liaisons (CTLs)—who bridge operational and strategic functions to provide continuity and accountability.

By embedding these elements within feasibility and startup operations, sponsors and CROs can deliver greater clarity and consistency for sites, reducing uncertainty and improving overall trial efficiency.

Engagement as a strategic differentiator

Sites are the operational heart of clinical trials. Their experience, capacity and involvement determine how effectively participants can be recruited, enrolled and retained. For this reason, site engagement is emerging as a measurable strategic discipline, not a soft skill.

A site-centric approach transforms startup and activation efficiency by replacing bottlenecks with collaboration, transparency and trust. The solutions that make the greatest impact are those that balance innovation with empathy, and systems with relationships.

Sustainable success in clinical trial delivery depends on listening to all stakeholders, including sponsors, sites and participants, and designing processes that serve each of them. Organisations that invest in site partnership position themselves for faster startup, smoother execution and stronger, longer-term collaboration that supports the lifecycle of the current clinical trial as well as future research opportunities.

In a landscape where every day counts, empowering sites through early engagement and consistent support is the most effective route to progress.