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

Intro

In many corners of the clinical research world, a credential or checklist often signals readiness. But when it comes to radiopharmaceutical trials, paperwork doesn't always reflect operational capability. A site may meet certification requirements, yet still be unprepared to handle the realities of theragnostic protocol execution, especially when multiple departments, radiation handling, and time-sensitive logistics are involved.

This post explores why standard certifications, like SNMMI Centers of Excellence or GCP compliance, are necessary but insufficient when evaluating true readiness for radiopharmaceutical research. As detailed in recent frameworks for clinical site assessment, readiness should be evaluated across infrastructure, operational workflows, study management capacity, and regulatory coordination, not just credentials [1].

Why Credentialing Falls Short

Credentialing is designed to standardize baseline competence. But in practice, it doesn’t assess whether a site can handle the procedural and logistical demands of an actual RLT protocol. For example, the presence of PET/CT equipment or nuclear medicine staff doesn’t guarantee coordination with pharmacy or dosimetry workflows.

According to a 2025 report from SCRS, radiopharmaceutical readiness requires significant resource planning, often across departments that don’t regularly collaborate [2]. It also depends on how flexibly a site can adapt to therapy-specific handling, imaging, safety, and monitoring requirements.

Readiness In Action

True trial readiness includes:

• Active coordination between radiopharmacy, imaging, oncology, and safety teams

• Availability of trained staff familiar with radiolabeled drug workflows

• Licensing and storage capabilities for novel isotopes

• The ability to integrate protocol-specific demands into existing operations

These criteria aren’t captured in most checklists. A 2024 peer-reviewed framework emphasized that trial readiness should not be assessed by infrastructure alone. Instead, it identified six key domains that reflect a site’s real operational fitness: research team experience, physical infrastructure, study and data management, ethics and safety oversight, and broader organizational support systems [1]. These dimensions help distinguish between surface-level preparedness and functional execution capacity.

What Sponsors Should Look For

Sponsors often evaluate trial readiness through feasibility surveys and credential verification. But operational alignment is harder to assess. A 2025 white paper recommends embedding site readiness evaluations into early feasibility stages and aligning protocol design with site capacity, not the other way around [3].

Trial success hinges not just on scientific merit but on a site’s ability to execute under real-world conditions. Industry reports, including analyses from SCRS and Worldwide Clinical Trials, continue to show that credentialed sites may still struggle with day-to-day delivery due to unresolved operational barriers [2][3]. Misaligned radiopharmacy hours, unclear communication protocols, or gaps in scheduling coordination frequently lead to protocol deviations.

These issues are rarely visible in pre-activation profiles. Yet they have material consequences: enrollment delays, costly amendments, and increased regulatory scrutiny. That’s why static checklists must be supplemented with dynamic, trial-specific readiness evaluations.

For radiopharmaceutical trials, operational fragility is a known variable. Protocol success depends on synchronized workflows across departments that often operate independently. Radiopharmacy, imaging, oncology, and safety need to function as an integrated unit, not isolated silos.

Sponsors who rely on credentialing alone risk overlooking execution risk. Theragnostic protocols magnify this exposure, requiring precise alignment of logistics, safety, and staff capacity before the first patient is ever dosed.

Regulatory Considerations

Regulators increasingly expect evidence that sites can perform protocol-specific tasks with precision and reliability, especially when investigational products involve radiation safety and advanced imaging. During pre-IND and end-of-phase meetings, sponsors may be asked to justify their site selection rationale. Demonstrating proactive readiness assessments can strengthen regulatory confidence and de-risk review timelines.

Readiness Impacts Trial Timelines

When sites are not functionally ready, the consequences often become apparent once the first patient has been enrolled, at which point it's already too late. Missed administration windows, staff shortages, or coordination lapses between departments can introduce protocol deviations or require costly amendments. This slows timelines, complicates data integrity, and ultimately delays patient access to potentially life-saving therapies.

Sponsors who invest early in operational site assessments can anticipate and mitigate these risks. By viewing readiness as a dynamic, trial-specific capability rather than a binary status, sponsors can align execution strategy with the real constraints and capacity of their trial network.

Theragnostic Insight: Trial readiness is not a checkbox. It’s an operational commitment.

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At Theragnostic Insights, we help sponsors distinguish between certified and capable. We evaluate radiopharma site readiness with a lens that includes infrastructure, training, workflow integration, and regulatory fit, so trials start smart and stay on track.

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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] Richesson RL et al., 2024. A Framework for Assessing Clinical Trial Site Readiness. Journal of Clinical and Translational Science

[2] Society for Clinical Research Sites (SCRS), 2025. Preparing Clinical Sites for Radiopharmaceutical Trials. SCRS

[3] Worldwide Clinical Trials, 2025. Radiopharmaceuticals — Operational Implications in Strategic Program Design. Worldwide