CSI was asked to support a client trial for sourcing of grass pollen allergen tests. There were 2 main concerns:
- – No product was licensed in all countries where the trial was running
- – Quantities required were considerable and the Sponsor was worried about the availability of the required quantity in the timelines to support the trial
The licensing aspect was clarified since the allergy test products were referred to as equivalent in the literature, the composition was essentially the same and use of the unlicensed products is common in many markets.
For consistency of study results, it was preferred to use the same test across all patients, which meant centralised supply and use of a product (even if unlicensed in a specific country) was justified. This was the basis for submission of the selected products to the country Regulators.
CSI’s solution for the large quantity and the sponsor’s concern was to obtain direct access not from just one but from two independent Manufacturers who agreed to supply the trial.
When it came the time to order, one of the Manufacturers indeed could not support the volume due to production changes and we worked with the backup source. The study ran to schedule and the client was satisfied.