Clinical Packaging
Clinical Packaging
At QCS, we recognise the challenges sponsors face to get the product through development into a clinical packaged form. Utilising a wealth of experience within our team, we partner with you to manage the complexities of clinical trial packaging from early phase 1 and investigator-initiated studies to larger complex phase II and Phase III randomised studies. Our meticulous approach guarantees GxP Quality compliance and QP certification of assembled patient kits ready for use in the clinic.
At QCS we have procedures to blind the IMPs and placebo in accordance with the protocol and study design requirements. Our packaging and labelling experts set up blinding strategies that include matching physical attributes, aligning colour and print style, using the same packaging materials including cartons tamper seals.
Randomisation is fundamental for any clinical trial involving treatment comparison. It mitigates selection bias, promotes similarity of treatment groups and, contributes to the validity of statistical tests.
Our qualified statistician works with you to set up strategies for Randomised Controlled Trials, including generating validated randomisation schedules based on the study design.
We also work with IRT interface that supports patient enrolment, randomisation, inventory management, and study drug dispensing.
We provide a full range of bespoke packaging services based on the clinical trial sponsor’s protocol and the global trial regulations; we offer:
- Secondary packaging for all dosage forms and devices
- On demand and direct patient packaging
- Analytical testing , stability packaging
- Blinding strategies
- Extension of expiry date
- Patient kit labelling and assembly
- NIMP over labelling
- Cost effective and subject compliance
- Seperate gowning , packaging and storage areas.
If the investigational medicinal product is due to expire,we can work with the sponsors to perform additional labelling for expiry date extension
under full GMP conditions.
We can also set up the Primary packaging supply chain at our partner companies.
To discuss your Clinical Packaging requirements, contact our dedicated team today.🌟