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Case studies · Clinical trial sponsor, biotech company

Comparator sourced, labelled and released

An authorised medicinal product was to serve as a comparator in a clinical trial. We oversaw its GMP-compliant sourcing and labelling and released the product.

How it went

Starting point, approach, outcome.

Told plainly, in the order it actually happened.

Anonymised. Confidentiality is part of our business; we only name clients with their consent.

Starting point

What the client came to us with.

An authorised medicinal product was to be used as a comparator in a clinical trial. For this, it had to be packaged and labelled for the specific trial in compliance with GMP. The sponsor needed a partner to release the comparator for the trial.

Approach

What we actually did.

We oversaw the GMP-compliant sourcing of the authorised medicinal product and its manufacture as a comparator (in this case, labelling). We then released the comparator for use in the clinical trial.

Outcome

The outcome.

The clinical trial went ahead. GMP oversight and batch release came from a single provider, and manufacture was carried out together with a partner.

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