Supply chain steadiness
By: Gary White, BSc, CA-AM | June 28, 2016
How an integrated supply chain management approach cuts time, saves money and makes for happy investigators and patients.
Clinical trial designs are becoming more complex, and there are increasing demands on clinical supply managers to move new therapies through the supply chain more efficiently and cost-effectively. But they can’t do that without an effective communication and collaboration strategy between all vendors and the sponsor.
It is not uncommon for a single site to have multiple vendors all delivering critical pieces of a treatment protocol –one vendor may supply the drug, while another supplies the IV bags or injection tools, and a third develops the placebo. If any one of these vendors fails to meet their deadlines or delivers the wrong version of their product, the entire trial is impacted. Patients miss treatments, sites miss deadlines and quality errors occur that could threaten the integrity of the research. Even when everything arrives on time, sites are often overwhelmed by the piles of boxes and packing material, and multiple, disparate databases make it frustrating to even figure what they have and what they still need.
To avoid such risks, sponsors may want to consider an integrated supply chain strategy where a single vendor or group of vendors takes responsibility for meeting all of a trial or site’s supply chain needs. At Quintiles, our integrated supply management team includes our own team of experts along with Thermo Fisher Scientific, a biotechnology product development company, and Cenduit, a clinical Interactive Response Technologies (IRT) provider. Together, we work collaboratively with sponsors from the beginning of every trial to define roles and responsibilities for all players, establish delivery deadlines and communication expectations, and identify and mitigate risks that might otherwise result in costly delays and errors.
That early and ongoing communication is key to the success of this process. For example, our team recently worked on a trial that required a blind comparator that looked exactly like the study material, including the packaging, specific coloring of the drug and the unique delivery mechanism. While still in the planning stages of the trial, our team recognized that the comparator would require significant design work, so we immediately brought on an engineer to craft the product in time to support ‘first patient in’ deadlines. If we had not been working together with the client from the outset, the time needed to achieve this goal might not have been identified until well into the trial design, which could have created a months-long delay. This is just one of the countless examples of how an integrated supply chain strategy can solve problems before they occur.
Having an integrated solution also makes life a lot easier for trial sites, which receive everything they need in a single box and can receive materials as needed rather than stockpiling them against every available wall. This just-in-time access is enabled by a centralized data sharing system where they can use a single database and log-in to determine exactly what they have in stock, what they need and how long it will take to get it. This single supply chain view makes sites more efficient and alleviates the need for investigators to utilize multiple systems using multiple passwords just to manage their purchasing needs. We know that administrative burden is heavy for investigators and site staff – with some 74% to 80% of sites around the world participating in just one clinical trial and never conducting another, these efficiencies are critical for alleviating some of that burden to encourage repeat site participation in clinical research.
While this Integrated Supply Management (ISM) solution is relatively new for Quintiles, we are already seeing positive trends in which trial sites experience fewer quality incidences when adopting an ISM approach. They also have happier investigators and satisfied patients who are able to complete their treatments on schedule and as quickly and easily as possible.