Parexel’s Clinical Logistical Services group distributes clinical trial supplies, lab services, and ancillary supplies worldwide.
The Singapore depot will provide services not offered by the division before, including secondary packaging and labelling services, which the company President told In-Pharmatechnologist.com would speed study times and first-in-patient milestones.
“From a labelling standpoint there are strict GMP regulations,” explained Mark Goldberg, President and Chief Operating Officer, Parexel. “Sometimes changes occur in a clinical trial, or there’s a change in the expiration date of a product. If our regional distribution centres have the capability to relabel, then we can relabel on site as opposed to having to resend the product to the manufacturer. There’s a real saving in cost and time.”
The company’s Clinical Logistical Services also offer risk evaluation and mitigation planning for investigational site supply, technology to track shipments and inventory, consulting on global import and export compliance, and expiry and update labeling services.
Getting specimens across borders
The company President said the latest depot was part of a network which simplified trials for clients by keeping up-to-date on regulations worldwide. The companies’ trial supply infrastructure extends to North America, Latin America, Europe, Africa and the Asia Pacific region.
“There are a lot of nuances in dealing with clinical trial supplies. Different regulations apply in more or less every country.
“There are many companies that play in the space of generic logistics – the big packaging companies – but they tend not to have the expertise on the regulatory side, for instance about import and export law relating to investigative products, or biological specimens that cross borders. We have a deep knowledge of the regulatory process.”
One change to a regional regulation could mean a product being stuck at a border and a trial patient not receiving medication, said Goldberg, unless a company stayed on top of the changing rules.
Predicting biologics supply
Goldberg told us the company coupled its physical logistics services, like distribution and inventory, with information from e-clinical systems obtained from its clinical trials.
The company’s randomisation informatics “allow us to know how many patients are involved on a site and how many are on what arm,” said Goldberg.
“Biologics are expensive. This way, we can know exactly what supplies are needed, and maintain the blind [study]. It allows for tighter inventory management – otherwise pharmaceutical partners would have to guess.”