Built for What’s Next Redefining Clinical Site Design for Theragnostic Trials
Why Site Design Matters Now
Theragnostic trials are becoming an increasingly routine component of modern oncology development, reflecting broader trends in precision medicine. But while radiopharmaceutical innovation has accelerated, most clinical site infrastructure has not kept pace. Traditional trial environments, built around small molecule or immunotherapy paradigms, often lack the technical readiness, integrated workflows, and compliance measures required for radiolabeled therapeutic agents. The result? Logistical delays, missed imaging windows, radiation safety concerns, and stalled development timelines.
Theragnostic protocols place unique and simultaneous demands on radiopharmacy, imaging, oncology, and safety operations. As these programs scale, sponsors can no longer afford to retrofit underprepared sites or assume infrastructure adequacy. Trial-ready now means purpose-built.
Inside a Trial-Ready Theragnostic Site
Clinical site design for radiopharmaceutical trials must be engineered from the inside out. According to the Society for Clinical Research Sites, the infrastructure and coordination burden for radioligand therapy trials spans not only imaging and dosimetry, but also nuclear waste handling, isotope storage, staff radiation credentialing, and interdepartmental scheduling [1].
Future-ready sites should include:
• Designated radiopharmacy and isotope handling zones compliant with FDA/cGMP regulations
• Coordinated PET/SPECT and therapy suite scheduling systems
• Secure and shielded storage for radioactive materials
• Trained and cross-functional staff in nuclear medicine, oncology, and pharmacy
• Infrastructure that supports both outpatient and inpatient protocol flexibility
A 2024 MDPI report on radiopharmacy facility design reinforces that layout, air handling, containment systems, and workflow zoning are not just operational preferences. They are regulatory essentials [2]. For sponsors, trial success starts at the blueprint level.
Site Design as an Execution Strategy
Theragnostic readiness is not only about safety or compliance; it is about scalability. In a 2024 Wellcome Open Research review, experts noted that inadequate infrastructure was a consistent cause of trial failure across high-investment therapeutic areas [3]. When clinical environments are not designed to support protocol demands, study execution slows, costs increase, and patient access is delayed.
For example, a site may have appropriate imaging equipment, but if radiopharmacy workflows are not integrated, or if nuclear medicine staff are unavailable during administration windows, protocol adherence can break down. Sponsors often discover these gaps only after activation, by which point timelines and budgets are already at risk.
A 2025 Lancet Global Health editorial highlights the global infrastructure disparities in clinical trial delivery and underscores the importance of aligning site capabilities with therapeutic innovation [4]. In radiopharma, this alignment is a prerequisite, not an afterthought.
The Investment Case for Infrastructure
Investors are increasingly recognizing that trial site infrastructure is not just a cost center. It is a source of R&D efficiency and value protection. A 2023 ACCC paper emphasized the importance of early site capability assessments and infrastructure planning to accelerate oncology trial readiness [5]. The paper also notes that community sites are often overlooked despite their potential to increase geographic access and enrollment equity if adequately supported.
Readiness investments at the site level reduce the likelihood of mid-trial amendments, regulatory issues, and protocol deviations, all of which carry real financial implications. With more radiotherapeutics entering Phase I and II studies, infrastructure strategy is becoming a defining variable in asset valuation and partner confidence.
Infrastructure also influences clinical credibility. When sites demonstrate reliability in scheduling, workflow coordination, and patient throughput, sponsors gain confidence not only in the science but in the path to approval. This perceived reliability is critical during licensing discussions and investor evaluations, where predictability can influence both milestone funding and valuation models.
What Sponsors Should Do Now
1. Reassess What "Ready" Really Means - Move beyond credentialing checklists and evaluate actual operational capacity, infrastructure, and interdepartmental alignment.
2. Design with Integration in Mind - Ensure clinical sites are configured to support end-to-end theragnostic workflows, from radiopharmacy through patient monitoring.
3. Engage Early with Sites - Use site readiness frameworks during feasibility to identify infrastructure gaps and co-develop solutions before protocol activation.
4. Invest in the Ecosystem - Consider partnership models that include infrastructure support, training, or workflow optimization services.
Theragnostic Insight - Infrastructure isn’t background. It’s strategy.
At Theragnostic Insights, we help sponsors future-proof their trial execution plans. Our team assesses site infrastructure and workflow readiness to reduce risk and accelerate development from the ground up.
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
7. Speed as Strategy: How Site Scarcity Is Slowing Radiopharmaceutical Pipelines
8. One Roof, Many Bottlenecks: Why Fragmented Site Models Undermine RLT Trials
References:
[1] Society for Clinical Research Sites (SCRS), 2025. Preparing Clinical Sites for Radiopharmaceutical Trials: A Comprehensive Guide. SCRS
[2] Asor A., Metebi A., Smith K., Last K., Strauss E., Fan J., 2024. Design and Construction of a Radiochemistry Laboratory and cGMP-Compliant Radiopharmacy Facility. MDPI
[3] Merson L 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] ACCC, 2024. From Readiness to Research: Building Clinical Trial Capacity at Community Cancer Centers. ACCC Journals
