Introduction

Dealing with Biotechnology dervided products and IMPs supplies for clinical trials and mastering different aspects of clinical pharmacy is a daily activity for our CRO .
This activity is conducted with complete adherence to guidelines and in observation to storage and cold chain management updated rules in addition to our customisation of products identification and taracking with adequate QR code technology.
We understand the need of a thorough care of the investigational medicinal products during all steps of the study and we implement an efficient way to track the lots of IMPs from manufacturing plant to patient’s use.
Security of the products is continuously ensured with innovative, user friendly identification methods and temperature tracked by state of the art temperature loggers, provided by our leading partners.
Cold chain management is an effective field or R&D and operations in our company and we have with our collaborators and a multidisciplinary team developed a “Biotherapies Pole” dedicated to, biotechnology derived products such as Biosimilars , where all up-to-date aspects of transport /logistics , tracking , identification , and administration recommendations are dealt with and kept at the highest standards.
Furthermore, we take in charge coding, labelling, blinding and un-blinding procedures for double blind controlled trials and ensure an adequate storage and accountability of the products is made.
Our flexible though reproducible way of doing , identifying critical points in the logistics/transport and storage process , permits us , in compliance with local pharmaceutical regulations, to achieve the same quality , everywhere we intervened.