Ensuring On-Time Start of a Multicenter Diagnostic Radiopharmaceutical Trial

1. sty 26, 2026

How Axcellant stabilized isotope supply, synchronized global imaging operations, and prevented a multi-month program delay.

At a Glance

• Study type: Multicenter diagnostic radiopharmaceutical trial (PET and/or SPECT)
• Key Challenge: Single-source isotope supply & incomplete Contract Manufacturing Organization (CMO) tech transfer
• Regions: Multinational (EU and US)
• Critical Requirement: Class 7–compliant global logistics
• Outcome: On-time First Patient In (FPI), stable study execution, and helped avoid a multi-month delay

Background & Context

The sponsor was preparing a multinational diagnostic radiopharmaceutical trial facing significant operational vulnerabilities:

• A single global isotope supplier creating a high dependency risk
• Pending technology transfer to newly selected CMOs
• Need for harmonized imaging protocols across PET/SPECT sites
• Requirements for Class 7–compliant transportation of highly time-sensitive isotopes
• Tight timelines linked to investor milestones and regulatory strategy.
  Any disruption in manufacturing or logistics would have pushed the program off its critical path.

The Challenge

The operational barriers were complex and interdependent:

Supply Chain & Manufacturing Constraints

• Only one qualified global isotope supplier
• Technology transfer to newly selected CMOs not yet completed → manufacturing uncertainty

Imaging & Logistics Complexity

• Short isotope half-life requiring precise enrollment + logistics synchronization
• Variable PET/SPECT equipment and acquisition protocols across sites
• Need for centralized Quality Control/Quality Assurance (QC/QA) and blinded image reads

Vendor & Timeline Pressure

• Multiple vendors needing coordination under compressed timelines
• Sponsor-imposed deadlines that could not shift without strategic consequences

Axcellant’s Integrated Approach

Axcellant deployed its Integrated CRO + Imaging Core Lab model, bringing together supply chain, imaging science, clinical operations, and regulatory oversight into one coordinated execution framework.

Supply Chain & CMO Acceleration

• Activated an emergency isotope supply chain through the original global supplier
• Supported CMOs and initiated accelerated tech transfer
• Stabilized manufacturing readiness ahead of FPI

Imaging & Operational Harmonization

• Developed and deployed Class 7–compliant logistics plans
• Synchronized isotope delivery with patient enrollment at every site
• Standardized imaging protocols across all PET/SPECT locations
• Enabled centralized image QA, blinded image reads, and KOL supervision

Continuous Senior-Level Oversight

• Daily multi-vendor coordination and proactive issue resolution
• Real-time operational dashboards for sponsor visibility
• Early escalation and mitigation of manufacturing, logistics, and imaging risks

The Outcome

Delivered What the Sponsor Needed Most: Time.

Axcellant’s senior-led, parallel execution strategy achieved:

• On-time FPI, despite global supply-chain constraints
• Stable execution pace maintained for the remainder of the study
• Fully activated PET/SPECT imaging network without quality drift
• Helped avoid a multi-month delay associated with the pending tech transfer
• Strengthened long-term manufacturing and operational readiness
  These results kept the sponsor on track for critical clinical, regulatory, and strategic milestones.

Why It Matters for Radiopharma Sponsors

Radiopharmaceutical trials fail or stall for three predictable reasons: supply chain fragility, manufacturing uncertainty, and imaging variability.

This case demonstrates how Axcellant eliminates these vulnerabilities through:

• A senior-led, boutique CRO model
• Integration of logistics, imaging, operations, and supply chain in one coordinated system
• A proven ability to deliver under pressure, where timing and precision are mission-critical

For PET, SPECT, theranostic, or diagnostic radiopharmaceutical developers, Axcellant provides executional confidence and partnership capable of stabilizing the most fragile elements of the trial.

Interested in accelerating your radiopharmaceutical program?

Speak with our Nuclear Medicine & Imaging Operations Team. Contact us to discuss your study needs.