Infrastructure as Investment Strategy: Clinical Site Access and Radiopharma ROI

The Capital Equation Behind Clinical Access

Investors don’t typically list “clinical site availability” as a line item in radiopharmaceutical diligence. But they should. Site access is increasingly recognized in peer-reviewed research as a structural determinant of trial success and investment risk [1][2][3][4].

Radiopharmaceutical programs depend on more than just promising compounds. They require imaging infrastructure, nuclear medicine expertise, radiation safety protocols, isotopes with tight half-lives, and multi-specialty coordination. When qualified trial sites are scarce, timelines slip and budgets bloat. That directly impacts return on investment.

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Why Infrastructure is the New Rate-Limiting Step

The radiopharma pipeline is expanding rapidly, but clinical infrastructure has not scaled proportionally, creating capacity bottlenecks documented in recent multi-institutional reviews [3][4]. According to recent investment analyses, site constraints are increasingly cited as a core reason for R&D delays and cost overruns. In markets with already stretched PET/CT capacity or limited radiopharmacy support, even a credentialed site may lack the real-world readiness needed to initiate radiopharmaceutical trials efficiently [1][2].

This mismatch is especially visible in Phase I and II trials. Sponsors may secure IND clearance but then spend a disproportionate amount of time struggling to find sites that can execute dosimetry, coordinate imaging, and manage therapy administration within protocol-defined timelines.

And that delay isn’t just operational, it’s financial.

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How Infrastructure Gaps Show Up in Practice

Take, for example, a trial involving a radioligand therapy requiring precise coordination between the radiopharmacy, nuclear medicine, and oncology departments. Even when a site had all the baseline certifications, the trial can encounter repeated delays due to incompatible scheduling systems, conflicting departmental workflows, and limited radiotracer storage. These issues, not commonly flagged during credential review, can result in multiple patient cancellations, protocol deviations, and a enrollment delays enrollment delay.

This is not just an example. Reports continue to show that even high-performing academic centers may struggle with cross-departmental coordination and radiopharmaceutical logistics [1][2]. Infrastructure gaps in staffing, radiation safety protocols, or isotope supply chain timing can derail timelines, often after capital has already been deployed.

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The ROI Risk of Bottlenecked Access

For venture-backed biotech or platform-based development, every quarter counts. The inability to activate trial sites directly slows data generation, value inflection, and follow-on financing.

For later-stage or big-pharma partnered assets, lack of site readiness inflates trial costs and compresses launch windows. When the lack of infrastructure limits patient access enrollment rates drop, timelines extend, and capital efficiency declines.

Infrastructure is no longer a “nice to have”, it’s a core driver of R&D ROI.

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Redefining Diligence: What Investors Should Ask

Investors assessing radiopharma programs must now evaluate site access risk alongside scientific merit. That includes:

• How many trial-ready sites are realistically available for this indication and agent type?

• What geographic disparities exist, and how might they impact enrollment?

• Has the sponsor built early alignment with nuclear medicine departments, imaging workflows, and isotope suppliers?

• Are there integrated networks or partnerships in place to support activation?

These questions aren’t traditionally part of biotech diligence; but for radiopharma, they should be.

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Infrastructure as a Regulatory Readiness Signal

Infrastructure also plays a central role in regulatory confidence. During pre-IND meetings or regulatory submissions, sponsors are increasingly expected to justify site selection strategies based on real operational capacity, not just credentialing. Regulatory bodies have flagged delays stemming from inadequate site activation planning and fragmented trial execution, factors directly linked to infrastructure readiness [2][5].

By incorporating site access strategy into early development planning, sponsors not only strengthen their clinical timelines but also reduce regulatory friction and risk of post-submission scrutiny.

At Theragnostic Insights, we help investors and sponsors assess clinical infrastructure as a strategic lever, not just a cost center. From evaluating site networks to modeling operational risk, we translate clinical complexity into capital clarity.

That clarity becomes a competitive edge for trial execution, valuation, timelines, and long-term portfolio performance.

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‍Stay tuned for more in this mini-series: Clinical Capacity Crisis: The Hidden Bottleneck in Radiopharma Development.
In the coming weeks, we’ll continue exploring the clinical capacity crisis holding back radiopharmaceutical innovation; from regional access gaps to operational gridlock and infrastructure blind spots. Don’t miss the next post as we map out the road to a truly trial-capable ecosystem.

1.     The Trial Site Gap: Why Radiopharmaceutical Innovation Is Hitting a Wall

2.     Geography Is Destiny: The Clinical Access Gaps in Radiopharmaceutical Research

3.     Operational Gridlock: Where Radiopharmaceutical Trials Break Down on Site

4.     Beyond the Badge: Rethinking What “Trial-Ready” Really Means in Radiopharma

5.     Infrastructure as Investment Strategy: Clinical Site Access and Radiopharma ROI

6.     Built for What’s Next: Redefining Clinical Site Design for Theragnostic Trials

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References:

[1] Society for Clinical Research Sites (SCRS), 2025. Preparing Clinical Sites for Radiopharmaceutical Trials: A Comprehensive Guide. SCRS

[2] Richesson RL et al., 2024. A Framework for Assessing Clinical Trial Site Readiness. Cambridge University Press

[3] Thorn JC et al., 2024. Infrastructure, Capabilities, and Capacities Required for Clinical Trials Design and Delivery: A Rapid Scoping Review. Wellcome Open Research

[4] Harris E et al., 2025. Improving the Clinical Trial Environment and Infrastructure: Moving from Global Resolution to Action. The Lancet Global Health

[5] Sedrak MS et al., 2023. Measuring What Matters in Trial Operations: Development and Validation of the Clinical Trial Site Performance Measure. Journal of Clinical Medicine

[6] Moffitt Cancer Center and ACCC, 2024. From Readiness to Research: Building Clinical Trial Capacity at Community Cancer Centers. ACCC Journals