The clinical supply chain is unique to itself, distributing to hundreds of study sites, often world-wide. The rapid growth of biological based pharmaceuticals is apparent in clinical trials today, creating even greater demands on clinical logistics practitioners handling biological specimens such as DNA and RNA. Cold Chain IQ provides industry insights exploring how the efficient supply of clinical materials and IMPs is the lynchpin to ensuring patients are dosed on time and clinical trials run efficiently.
Pharma Logistics IQ brings you a rundown of the latest updates and newsworthy developments involving the pharmaceutical logistics around the globe. Updates include new regulations, discoveries and reports of non compliance with GDP. Seafreight Weight Regulations come into effectNew regulations regarding container weight declarations (Veri Full Article »
A round up from the attendees and partners on site at the 13th Annual GDP & Temperature Management Logistics Global Forum 2015, including the FDA. Full Video »
Mary Foster is the chair of the USP's committee on Packaging, Storage and Distribution. In this podcast, she discusses the regulatory challenges of transporting and distributing clinical trial materials and biologics, and also her position with Athena Pharma Solutions. Have Your SayRate this feature and give us your feedback in the comments Full Podcast »
Clinical trial material (CTM) or investigational medicinal products (IMP) are an important part of the early stages of the life science supply chain. As trials are being run on a global scale, in markets with less than ideal infrastructure, there is a dire need for companies to work with specialized cold chain experts to engineer and design innovative distribution processes. Cold chain failure may lead to: the patient being administered an unsafe product; liability based on compliance infractions; inconsistent data results; or an entire shipment’s product integrity could be rejected by the quality department, resulting in costly delays. Full Column »
In striving to secure the smooth supply of clinical trials, professionals will need a thorough awareness of the chain’s stumbling blocks as well as the respective strategies to best navigate them. With this in mind, Pharma IQ examines the clinical trial supply pain points and the responding technologies and tactics which have the potential to optimise current clinical trial supply practises. Full Whitepaper »