Short-lived isotopes and theranostic pairings leave no room for logistics gaps or calibration drift. Watch this on-demand session to learn the operational frameworks that protect data integrity and keep pivotal timelines intact.
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Operational gaps in pivotal radiopharm trials cost more than time
Radiopharmaceutical development has moved from oncology frontier to clinical standard, and pivotal trial execution has not kept pace. A 15-minute delay in isotope delivery or a single calibration error at a site does not produce a protocol deviation – it produces unusable patient data. For sponsors advancing theranostic programs into registrational studies, the difference between a successful submission and a costly timeline disruption is almost always operational, not scientific.
PSI currently runs over 40% of all industry pivotal radiopharmaceutical trials and has achieved a 97% last-patient-in on-time rate across complex global programs. That track record is built on end-to-end operational synchronization across radiopharmacy production, site qualification, dosimetry documentation, and regulatory-grade imaging workflows — coordinated by teams that stay on your program.
This on-demand session with Jason Vilardi, Therapeutic Area Director within PSI’s Specialized Study Support Services (4S) group, delivers the operational frameworks sponsors need before sites are activated, not after timelines slip.
What you can expect to learn
Jason draws on more than 15 years leading radiopharmaceutical, oncology, and cell therapy programs to address four areas where execution risk is highest:
Radiotracer supply chain alignment
How to synchronize radiopharmacy production schedules with patient injection windows to eliminate lost doses – a recurring failure mode that no protocol amendment can recover
Global site qualification standards
Practical qualification methods, from phantom imaging tests to specialized technologist training, that keep quantitative PET and SPECT data consistent across multiple regions and regulatory jurisdictions
Imaging-to-dosimetry workflow integration
How to structure CMC documentation and biodistribution data so imaging endpoints meet the increasingly specific expectations of FDA and EMA reviewers at submission
Automation and emerging modalities
Where AI-driven lesion segmentation and digital PET enhancements meaningfully reduce human error and accelerate quality control, and how to adopt alpha emitters and novel tracers without losing operational control
The people in the room
Jason Vilardi
Therapeutic Area Director,
Specialized Study Support Services
PSI
About the speaker
Jason brings over 15 years of experience advancing radiopharmaceutical, oncology, hematology, and cell therapy trials globally. He has built and led specialized imaging operations teams, designed predictive analytics infrastructure, and served as primary CRO contact across numerous global regulatory audits. His work spans protocol development, imaging biomarker integration, regulatory strategy, and audit readiness, with a consistent focus on translating scientific complexity into executable, inspection-ready study designs.
