Selecting appropriate clinical packaging and shipping strategies can be the difference between an efficient clinical supply chain, or an expensive fiasco. This case study details how Sherpa Clinical Packaging partnered with South Bay Therapeutics* to craft the best clinical supply management strategies for their multiple, complex clinical trials.
MULTIPLE TRIALS, DYNAMIC SOLUTION
South Bay Therapeutics, a Southern California pharmaceutical business, was conducting as many as five studies simultaneously for the same drug, which led to supply challenges. South Bay Therapeutics’ drug product is a viscous injectable delivered in vials or pre-filled syringes. Because the inventory needs for each site changed frequently, packages had to be reworked often to meet new clinical demands, a time-consuming and costly process.
In addition, some sites handled multiple studies with differing protocols. Each package had to be labeled clearly, to avoid errors, and delivered quickly to the appropriate site.
“We chose Sherpa because we were looking for someone who could quickly adapt to a fast-changing environment and had the right quality systems and a nice facility.”
–Senior Director, South Bay Therapeutics
South Bay Therapeutics selected Sherpa Clinical Packaging to manage its labeling, packaging, storage and distribution activities. Sherpa’s commitment to quality, responsiveness and ability to flex to ever-changing clinical requirements made them the obvious choice. Sherpa’s initial role was labeling South Bay Therapeutics’ vials and re-pouching them with a desiccant.
To streamline the clinical supply preparation process, maximize efficiency and reduce costs, Sherpa’s project manager proposed just-in-time (JIT) pouch labeling. Rather than pre-labeling study-dedicated packages with information that might be changed – and subsequently reworked – Sherpa stored larger quantities at its San Diego facility (at 2-8° C), performing all necessary preparations but not confining product to a specific study or location.
As orders came in, Sherpa applied study labels and shipped drug product to the appropriate sites. Sherpa also recommended and sourced colored labels to differentiate studies, particularly useful at sites handling more than one trial.
THE BENEFITS OF SHERPA’S APPROACH
Sherpa’s JIT solution benefited South Bay Therapeutics in several ways. By reliably storing larger quantities of their drug, Sherpa always provided timely delivery. Eliminating the need to relabel product as trial needs shifted saved time, money, stress and frustration. In addition, Sherpa’s robust cold-chain logistics ensured end-to-end temperature control from storage facility to trial site.
Sherpa initiated just-in-time packaging in a matter of weeks, saving South Bay Therapeutics significant resources and ensuring the product arrived at all clinical sites exactly when it was needed.
“I was impressed by how quickly they implemented JIT. It was above and beyond what I’ve seen from other vendors.”