Case Study

Just-In-Time Packaging And Shipping Supports Multiple, Complex Clinical Trials

Just-In-Time Packaging And Shipping Supports Multiple, Complex Clinical Trials

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.

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-intime (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.

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.

"I was impressed by how quickly they implemented JIT. It was above and beyond what I’ve seen from other vendors."

Senior Director, South Bay Therapeutics

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.

Clinical trials are complicated endeavors, in which multiple participants – drug companies, contract manufacturing organizations (CMOs), clinical sites and others – must collaborate closely to meet multiple goals. Inevitably, challenges must be overcome.

One of Sherpa’s defining values is flexibility. Quite often, this means going to great lengths to maintain timelines and have all clinical supplies ready for the sponsor company’s critical first-patient date. If a CMO does not deliver a drug product on schedule, Sherpa finds ways to accelerate the packaging and delivery process and keep the company on their timeline.

"The most important thing is flexibility. Sherpa provides so many fast solutions. We change quickly, add studies, etc. If I email that I need something out today, Sherpa will make that happen. Our studies get taken care of. Our timelines get taken care of."

Clinical Trial Materials Specialist, South Bay Therapeutics

This is particularly important for small drug companies, where meeting milestones is closely tied to funding. When South Bay Therapeutics needed to initiate a new clinical study within two weeks, Sherpa did what was necessary to accommodate that timetable.

"It all comes down to good management because you’re going to run into bumps no matter what. If you have a strong relationship with the project manager, you can handle anything."

Senior Director, South Bay Therapeutics

For South Bay Therapeutics, another issue was redundant labels placed on the vials by their CMO. Unfortunately, the adhesive was quite strong and removing the labels was a time-consuming process. Working closely with his counterparts at South Bay Therapeutics, Sherpa’s project manager devised a creative solution: print an opaque piece to cover the existing label. The solution met all the requirements for South Bay Therapeutics and accelerated the final packaging process.

When South Bay Therapeutics switched vial suppliers, Sherpa noticed that the vials were slightly shorter and quickly found new labels to match the new vials.

In addition, when South Bay Therapeutics made the decision to cease handling its own ancillary supplies, such as syringes, needles, vial transfer devices, etc., Sherpa stepped in quickly to handle this function. The change was managed without disrupting supplies for any trials.

"Ancillary supplies were rapidly brought into Sherpa. I’m not sure other vendors could have done that so quickly and maintained quality."

Clinical Trial Material Specialist, South Bay Therapeutics

With a projected 55 percent increase in Sherpa shipments in 2017, Sherpa continues to build a loyal client base built on trust, hard work and a solution-oriented approach.

We recognize that our work plays a critical role in successful clinical studies. This is nail-biting time for many small drug companies, who may succeed or fail based on the results of a single trial.

For these and many other reasons, Sherpa is laser-focused on meeting our customer’s needs. That means being fast, nimble and leveraging our staff’s vast experience to anticipate and overcome obstacles. It does not matter how big or small a client may be, or whether the trial is a Phase 1, 2 or 3. We are always going to provide fast, flexible and reliable service for all customers.

"It has been a pleasure working with Sherpa. They are always good about suggesting a path forward that we may not have thought of. They have incredibly strong project management and are solution-oriented and customer-focused."

Senior Director, South Bay Therapeutics

Sherpa’s business is built to guide customers through the complex world of clinical supply management. Our managerial and operational systems accommodate ever-changing clinical projects, generating fast turnaround times without sacrificing quality. Our experienced team leverages superior knowledge to identify and execute creative clinical supply solutions for all clients.

These are the values that drive everyone at Sherpa.

Founded in 2010, Sherpa Clinical Packaging is dedicated to helping biomedical companies successfully complete clinical trials around the world. Sherpa provides comprehensive clinical materials management – packaging, labeling, distribution, storage, returns/reconciliation – for pharmaceutical, biotechnology, medical device and dietary supplement companies.

Sherpa specializes in labeling and packaging, cold-chain logistics, and supplying trials throughout the U.S. and globally.