Sponsors have specific requirements, depending on their clinical protocol.
Part of our job is to find the right products, sourced from the required countries, in the appropriate quantity, and with an expiry date that fits with the duration of the clinical trial.
Our broad supplier network enables us to meet these challenges.
Regular audits and follow-up of our suppliers ensure a secure supply chain.
In the case of clinical trials in Europe with comparator drugs from a third country, our QPs provide the EU certification for clinical use.
As well as sourcing comparators, we also manage the blinding of solid dosage forms (tablets or capsules) by over-encapsulation.
For clinical studies with a placebo arm, we fulfil our clients’ needs by manufacturing placebo capsules.
Our processes are designed and implemented to avoid cross-contamination: one dedicated manufacturing suite per treatment arm; control of each manufacturing step by a barcode scanning system; and a final quality control step after reconciliation of all the treatment arms.
Secure comparator supply chain
Flexible capabilities: manual or semi-automatic over-encapsulation, depending on the batch size
Verification of blinded product by visual inspection and analytical identification