Clinical trial budgeting faces pressure to modernize

Author: Katie Rothstein, Director, Data Delivery, Suvoda

Using current fair market value benchmarking data can cut costly delays

Clinical trial budgeting continues to be one of the most persistent challenges for sites and sponsors undertaking clinical research. While technology and processes have advanced in other areas, budgeting for clinical trials often remains fragmented and inefficient. Investigator grant negotiations, in particular, can be slowed by outdated financial source data and disparate processes. This leads to prolonged budget negotiations resulting in delays and strained relationships between sites and sponsors.

The consequences can be significant. Every day a trial is delayed comes at a cost—financially, operationally, and for patients awaiting new therapies. Delays in study startup are frustrating, undermine trial productivity, and contribute to missed milestones, including first patient in (FPI). Tufts Center for the Study of Drug Development (CSDD) estimates that delayed Phase II/III trials can lose about $40,000 per day in lost revenue, underscoring one impact of stalled negotiations.¹

This raises a critical question: How can clinical trial budgeting evolve to accelerate study startup and better serve sponsors, sites, and patients?

The challenges impacting investigator grant budgeting

Several long-standing budgeting barriers continue to delay study starts:

• Outdated or inconsistent data
  Budgets are often built on historical costs or generic benchmarks that don’t necessarily reflect current market realities. As a result, sponsors may underbudget while sites struggle to justify actual costs.
  
  
• Misaligned expectations
  Sponsors and sites want to manage costs and activate trials quickly while maintaining financial viability. Without establishing a strong financial baseline, negotiations can lag, eroding trust, and impeding activation.
  
  
• Disconnected manual workflows
  When budgeting tasks rely on email threads, spreadsheets, and one-off processes, errors can accumulate and handoffs slow down, adding avoidable time to the negotiation cycle.
  
  
• Lack of clear ROI measurement
  Many small and mid-sized sponsors and sites lack the tools to effectively evaluate their budgeting practices, creating conditions for inefficiency and avoidable delays.
  
  

4 Reasons why real-time benchmarking streamlines trial operations

One of the most significant advancements in clinical trial budgeting is the use of real-time fair market value (FMV) benchmarking site cost data. When sponsors and sites use real-time benchmarking data drawn from recent site costs across geographies, therapeutic areas, and study phases—it creates a foundation for site payments grounded in real-world conditions, not guesswork.

FMV benchmarking has clear benefits:

1. Faster study startup
   When sponsors and sites begin with realistic, data-backed benchmarks, they eliminate much of the back-and-forth that has historically slowed budget negotiations. The 2025 SCRS Landscape Survey found that 21% of sites have declined a trial outright due to budget disagreements—a costly outcome that better starting benchmarks can help prevent, ultimately accelerating FPI.²
   
   
2. Stronger site-sponsor relationships
   Rather than hypothetical rates or outdated “standard” costs, market-based benchmarks reflect what’s currently being agreed to across the industry. Both sponsors and sites benefit from this transparency. Sponsors have a stronger forecasting analysis to more closely align with what they planned—and what they will pay for—while sites receive fair, evidence-based compensation, which reduces friction during contract negotiations.
   
   
3. Greater financial predictability
   With budgets anchored in current market conditions, sponsors and sites can plan more effectively, gain financial clarity, and reduce the likelihood of unexpected delays during site initiation.
   
   
4. More agile studies
   Granular, real-time benchmarking data make it easier to adjust to protocol amendments, regional pricing differences, and evolving study feasibility concerns.³

Ultimately, real-time FMV benchmarking is not simply a tool for negotiation. It is a mechanism for building a more agile, transparent, and collaborative budgeting process. This accelerates study startup, improves operational efficiency, and primes trials for long-term success.

Beyond speed: real-time benchmarking benefits sponsors, sites, and patients

When budgeting starts with realistic, current market data, everyone wins:

Sponsors
Using up-to-date benchmarking data aligns expectations right from the start. A Tufts CSDD survey highlights persistent struggles with budgets and contracts as core site challenges postpandemic.⁴ By presenting data-backed proposals, sponsors minimize negotiation cycle times, reduce administrative burden and gain credibility, ultimately speeding trial activation while reinforcing trust with site teams.

Sites
Investigative sites routinely report challenges with initial budget proposals: 96% rarely or never accept the first offer, often because key items are missing or hidden costs aren’t addressed.⁴ This misalignment increases the site workload and negotiation duration. By using real-time benchmarking, sponsors can present budgets that more accurately reflect actual site effort and costs, reducing the need for extensive revisions and allowing sites to concentrate on research instead of protracted disputes.

Patients
Every week saved in budget negotiations translates into timelier trial activation and earlier patient access to potentially lifesaving treatments. While harder to quantify, the downstream impact is clear: Patients benefit when financial negotiations no longer stall trial timelines.

Data-driven startups drive more efficient trials

Clinical trial budgeting has long been viewed as a necessary but inefficient administrative task. But with compressed trial timelines, strained site resources, and increased competition  for patients, the budgeting process is playing a greater role in trial effectiveness.

Benchmarking, powered by real-time FMV data, changes trial budgeting from an adversarial process into a collaborative one—built on fairness, transparency, and shared goals. This shift doesn’t just accelerate first patient in; it helps create a more sustainable clinical research ecosystem where sponsors, sites, and patients all benefit from improved speed, clarity, and operational excellence.

For stakeholders across the industry, the message is clear: The time to rethink clinical trial budgeting isn’t coming, it’s here. Those who embrace smarter, data-driven strategies today will be best positioned to unlock faster, more efficient trials tomorrow.

References

1. Smith, Z.P., DiMasi, J.A., & Getz, K.A. New Estimates on the Cost of a Delay Day in Drug Development. Therapeutic Innovation & Regulatory Science. Published 2024 May.
2. Society for Clinical Research Sites. 2025 SCRS Landscape Survey Report. SCRS; 2025.
3. Harper, B., Dirks, A., & Getz, K. Assessing Investigative Site Outlook and Operating Experience Post-Pandemic. Applied Clinical Trials. Published 2023 March.
4. Goldfarb, N.M. Take Control of Site Costs with Clinical Research Terminology Codes. Applied Clinical Trials. Published 2024 September.

Authors

Katie Rothstein
Director, Data Delivery, Suvoda