The Cost Of Transactional Thinking In Clinical Research

By Denise N. Bronner, Ph.D., fractional chief strategist, Empactful Ventures

SCOPE Summit just wrapped up and what stood out the most this year wasn’t the latest AI-enabled promise. It was what I heard in the hallways around the resort: The drive to do meaningful research is still there from the sites and vendors, but they are tired of running into the wall.

That wall is the power dynamic in clinical trials.

See, sponsors hold the money and their capital determines which assets move forward, which programs scale, and which partners are selected. But trials do not function on capital alone. Operations require sites to execute, vendors to support, and patients to provide the data. Somewhere along the way, financial control became the absolute operational authority, and that misalignment is straining the entire ecosystem. Remove sites, vendors, or patients, and the whole model collapses.

RFPs, Optionality, And Internal Politics

Many sponsors structure RFPs primarily around competitive bids, creating environments where vendors are effectively fighting to be selected. These processes are designed to preserve optionality, encourage price competition, and demonstrate due diligence, but too often they fail to surface the real operational challenges sponsors are trying to solve.

In some cases, RFPs are executed simply to check a box, an internal requirement or window shopping rather than a genuine effort to identify the right strategic partner. Vendors invest significant time and resources responding to these bids, interpreting incomplete signals, navigating shifting priorities, and attempting to anticipate needs that are not clearly articulated. What is often missing is a transparent problem statement that outlines where sponsors actually need support, what success looks like operationally, and how partners will be measured once selected.

Compounding this is inconsistency in when competitive bids are required and when they are not. Some proposals move through formal procurement processes, while others are influenced by existing relationships or internal politics. Vendors quickly learn that even strong proposals can be sidelined by factors unrelated to capability or performance, leaving them operating within decision-making structures that are not always predictable or transparent.

What Sites Are Actually Carrying

Sites carry clinical risk, patient trust, and regulatory accountability, yet they often have the least influence over study design and execution strategy. While sponsors focus on asset timelines and portfolio priorities, sites are managing the operational realities that ultimately determine whether trials succeed or stall.

Most sites are balancing multiple protocols with competing priorities, frequent amendments, and increasing regulatory complexity — all amid staffing shortages. Contract negotiations routinely extend for months. Budget approvals stall. Payments are delayed. Yet enrollment targets and performance expectations rarely adjust to reflect these constraints.

Compounding these pressures is the fragmentation of site engagement. A single study can involve outreach from sponsor teams, CRO representatives, feasibility vendors, recruitment vendors, and technology partners often requesting overlapping information through different systems. Feasibility questionnaires are completed repeatedly for similar therapeutic areas, with little visibility into how responses are used or whether they influence study planning in any meaningful way. Data becomes outdated almost as soon as it is submitted, and sites rarely receive feedback on why they were or were not selected.

What sponsors often experience as necessary process, sites experience as operational noise.

Feasibility And Technology Fatigue

Feasibility was designed to reduce risk. In practice, it has become one of the most burdensome and least effective parts of the clinical trial process.

Sites are routinely asked to complete lengthy feasibility questionnaires, often repeating for the same therapeutic areas. There is limited insight into how their responses will ultimately inform study design, site selection, or enrollment strategy. These requests arrive from multiple sponsors and partners simultaneously, requiring sites to repeatedly estimate enrollment potential, staffing capacity, and patient availability while already operating at or beyond bandwidth.

Rather than functioning as a collaborative planning tool, feasibility has increasingly become a transactional exercise. Sponsors believe they are validating assumptions. Sites experience the process as extractive, duplicative, and disconnected from real-world capacity. Responses are frequently rushed due to volume, and data becomes outdated almost as soon as it is submitted.

This disconnect is amplified by technology. Separate portals for feasibility. Separate dashboards for recruitment. Separate systems for EDC, reporting, and vendor communications. Each new platform introduces another login, another workflow, and another demand on site staff already juggling multiple protocols. What may feel like incremental tools from a sponsor perspective quickly compounds into operational drag for sites, forcing constant context switching and increasing the risk of errors or delays.

Technology was meant to streamline clinical research. Instead, it has often redistributed complexity downstream, placing additional administrative burden on sites without meaningfully improving coordination or decision-making upstream.

Vendors Are Treated Like Commodities, Expected To Act Like Partners

Vendors operate within a system that routinely asks them to function as strategic partners while contracting them as interchangeable service providers. Expectations continue to expand: compressed timelines, evolving scope, and increasing pressure to innovate. And yet, these demands are rarely matched with corresponding adjustments in budget, authority, or visibility into upstream decision-making.

Increasingly, vendors are brought into studies only after foundational challenges have already surfaced. They are asked to accelerate recruitment on protocols with high screen failure rates, to stabilize enrollment after inclusion and exclusion criteria prove unrealistic, or to support sites that are already stretched thin. In these scenarios, vendors are expected to deliver results on studies they did not help design, populations they did not help define, and timelines that were set without their operational input.

Without early involvement, vendors lack visibility into eligibility assumptions, real-world site capacity, and historical screening performance. As a result, they are often placed in reactive positions, tasked with solving downstream execution problems that were created upstream during protocol development and feasibility planning.

Compounding this challenge is limited transparency once studies are underway. Vendors are frequently asked to drive recruitment without access to real-time screening or randomization data, making it difficult to identify bottlenecks in the funnel or adjust strategies proactively. At the same time, they remain accountable for performance metrics that do not account for delayed sponsor decisions, shifting priorities, or protocol amendments.

The result is a familiar pattern: Vendors absorb operational risk without shared authority, while sponsors retain decision control without equivalent accountability. Over time, this dynamic reinforces a system where execution partners carry responsibility for outcomes shaped by decisions they had little opportunity to influence.

What Sponsors Should Do

If sponsors truly want faster trials and better outcomes, optimization must start with how partners are engaged.

For Sites

Create a single site concierge model. Instead of allowing multiple internal teams and vendors to contact sites independently, sponsors should designate a single point of coordination — a site concierge who triages incoming requests and routes them internally to the appropriate teams. This dramatically reduces confusion, duplicate outreach, and operational disruption.

Consolidate data through a unified site-facing platform. Rather than layering additional portals, sponsors should move toward a single platform that pulls feasibility, recruitment, operational metrics, and study updates together in one place for sites. This reduces login fatigue, minimizes redundant data entry, and allows sites to engage with studies through a unified workflow.

Bring sites upstream as strategic operators. Sites should be involved earlier in protocol development and feasibility planning. That means engaging site leadership during study design, pressure-testing assumptions with real workload data, and building enrollment projections grounded in site-specific capacity.

For Vendors

Bring vendors in early. Vendors should be involved before protocols and timelines are finalized so operational realities can inform study design, recruitment strategies, and execution planning from the start.

Be transparent about recruitment performance. Sponsors should share real-time screening and randomization data so vendors understand what they are up against and can adjust strategy proactively rather than reactively.

Standardize contracting and decision timelines. Sponsors need consistent procurement and contracting processes with clear timelines and escalation paths, reducing delays driven by internal politics and enabling vendors to staff and deliver with confidence.

Rebalancing Power For Sustainable Execution

Capital will always shape clinical research. Sponsors assume financial risk, carry portfolio responsibility, and answer to investors and boards. That reality is not in dispute. What is in dispute is the assumption that financial control alone is sufficient to drive operational success. When those partners are engaged late, managed transactionally, or measured asymmetrically, the impact shows up quickly: slower enrollment, higher screen failure rates, mounting amendments, and avoidable delays.

The future of clinical research will be shaped less by those who think transactionally and more by those who build operating models that allow sites, vendors, and sponsors to succeed together.

About The Author:

Denise N. Bronner, Ph.D., has roughly 15 years of organizational thought leadership experience within the global healthcare space and has held various roles in academia, consulting, pharma, and venture capital. During her career, she has specialized in health equity, data-driven global therapy program strategy development, pitch and storytelling refinement, and identifying business opportunities within pharma. Beyond her professional endeavors, she’s passionate about enhancing diversity in STEM fields, serving on advisory boards, participating as a judge in pitch/business competitions, and mentoring young professionals. She holds a bachelor’s degree in biological sciences from Wayne State University, a Ph.D. in microbiology and immunology from the University of Michigan - Ann Arbor, and certification from the Venture Capital Executive Program from UC Berkeley Haas School of Business. She is the founder of Empactful Ventures, which currently consults healthcare-focused startups and venture funds, and she is a member of the Clinical Leader editorial board.