Function: Clinical trials

What requirements must pharmaceutical secondary packaging fulfil in clinical trials? What criteria are relevant for product protection, look, feel, information presentation? We’ll be happy to advise you to develop solutions with you for these – often extremely complex – packaging concepts.

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Clinical trials

New medications are tested in clinical trials. Objectives include finding answers to scientific research questions and improving the medical treatment of future patients. The studies are divided into four phases:
Phase I: test on healthy participants, above all with regard to active profile, dose-effect relationship and mode of action
Phase II: tests on ill participants with a specific clinical picture
Phase III: tests with many ill participants distributed over various countries
Phase IV: already approved medications in the approved indication

In phases II, III and IV, packaging is almost always required – often with sophisticated packaging solutions with compliance-boosting components. For legal reasons, the relevant information must be printed onto the primary product or directly onto the packaging (often multi-page label or folding cartons). Special constructions with internal protection to protect against breakage, labels for temperature monitoring, wallets for tablets or capsules and multi-chamber boxes for the additional housing of containers, application materials or similar are just a few examples of possible solutions.

As a system supplier, we naturally also offer you services such as blinding or the prepacking of your clinical trials or similar in addition to secondary packaging at our PharmaServiceCenter Packaging Services department in Großbeeren.

Compliance

improvement in compliance

Circle
More room

for information

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Full-service

provision thanks to system solution

Integrated folding carton solutions

These are folding cartons with numerous inner chambers and platforms for various investigational products and application materials (ampoules, vials, cannulas, bags), which should all be on one level. In the re-packaging made from cardboard (for the purposes of stability), there is an additional, integrated folding carton that allows the preparations to be stored compactly in a fridge. The products are thus prevented from touching, to prevent damage and to assist with the correct ingestion by separating the products clearly.

Wallet with Compliance Features

Wallet for blister pack with compliance-boosting printing for the correct taking or administering of the investigational product.

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