When a radiopharmaceutical expires within hours of manufacture, the drug’s chemistry, not the disease’s prevalence, decides where a trial can run. That constraint shaped every decision in a site identification project PSI CRO recently completed for a sponsor running an imaging study in Parkinsonian syndromes, and the sequencing the team used offers a replicable model for any short-lived investigational agent.
The product’s shelf-life, measured in hours from manufacture to patient dosing, meant site selection had to begin with contracted manufacturing organization locations rather than with patient populations. PSI mapped movement disorder clinics that fell within a viable geographic radius of each planned CMO site, then layered in investigator experience and enrollment feasibility. That order matters: reversing it, by identifying clinically ideal sites first, would have produced a list that looked strong on paper but couldn’t receive a viable dose. Parkinsonian syndromes present across a wide clinical spectrum, from idiopathic Parkinson’s disease to rarer atypical forms, and imaging studies in this category typically require centers with subspecialty movement disorder expertise rather than general neurology capacity, which already limits the qualifying pool before geography enters the calculation.
The radiopharmaceutical constraint is not unique to this program. FDA’s draft Q1 stability guidance, developed under ICH, addresses stability testing requirements for drug substances and products broadly, but short-lived radiopharmaceuticals face compounding operational pressure: each batch has a hard expiration window that cannot be extended by cold-chain optimization or alternative packaging. A site that is two hours outside the delivery radius on a slow logistics day is effectively unreachable. PSI’s approach of anchoring the site map to CMO coordinates first absorbs that hard constraint before any other variable enters the feasibility model.
For sponsors in this position, the practical consequence is a smaller but higher-confidence site list: fewer sites qualify by geography, but those that do can actually dose patients without a product loss event. The metric worth tracking in a study like this is not the number of sites activated but the proportion that successfully complete at least one dosing visit without a shelf-life failure, since that figure reflects whether the CMO-anchored strategy held under real operational conditions.
Source link: https://psi-cro.com/parkinsonian-syndrome-trial-site-strategy-cmo-geography/
Moe Alsumidaie, MBA, MSF, is founder and Chief Editor of Vanguard Publications, which publishes Clinical Trial Vanguard, Pharma Vanguard and BullScope, and Head of Research at CliniBiz. He has two decades in clinical trial operations and data science, with earlier roles at Genentech, Abbott Vascular and Stanford University Medical Center, and is a guest lecturer in clinical trial sciences at Rutgers University.
