Ten of the world's largest drugs manufacturers, including Johnson & Johnson, Pfizer and AstraZeneca, are taking part in a TransCelerate-run project, which aims to create a secure supply chain for medicines used in clinical trials.
I have written in the past about why we need more truly comparative drug trials. This should be a major step in the right direction by easing some of the cost and availability issues.
The software allows companies to buy drugs directly from each other when they are needed for a trial. By cutting out distributors, the supply should be more predictable, secure and inexpensive.
The idea was initially tested over 18-months using Microsoft Outlook and Excel but it became clear that a more sophisticated solution was required – especially as the volume of transactions grew.
The new system is based on a BPM (business process management) technology from Pegasystems – partly because pharmaceutical companies were already using its technology to process their commercial and clinical data.
The system keeps an audit trail of transactions, so companies can go back and check the exact composition of a drug they were using in a particular test. It also allows the pharmaceutical companies to share documentation about the drugs they are using, and alert others when they need an urgent delivery of drugs.
As well as working to streamline the drug supply side of trials, TransCelerate strives to harmonise GCP training, by independently assessing currently available third-party courses.
Our ICH GCP training meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors.
Read more [here].
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