Amgen Sets High Bar For Clinical Trials

Clinical trials are essential to getting medical treatments from lab to market, but they're also complex. To simplify the process, Amgen, a global biotech company, decided to integrate key elements of its clinical trial material supply chain with its global ERP system so it could more easily manage inventory required for clinical trials. It launched the Clinical Drug Supply System Redeployment project to increase the efficiency of Amgen's planning and compliance, and provide visibility into every stage of the clinical material supply chain process.

Clinical trials generally randomly assign patients to one of two different courses of treatment: One group is on the Amgen product and the other either a comparison product or a placebo. The trials are blind, so no patients, Amgen staffers, or physicians know which treatment is being administered.

This is where Amgen's inventory management, distribution, and reconciliation systems come into play. Behind the scenes, biostatisticians develop randomization tables to ensure that there's no way for clinical personnel to determine which patient gets which treatment. Tracking codes are generated for each of the medication kits assigned to the patients, which contain the drugs assigned to each patient, along with vials, syringes, and other equipment needed to conduct the trial. The kits are sent to physicians conducting the trial, who may be located in hospitals or clinics all over the globe.

"Our computer systems track the patient kit that was given to patient X at site X on a certain day," says Diana McKenzie, Amgen's senior VP and CIO. When the trial is over, the team correlates results with the applicable course of treatment. "Was it an Amgen drug, a placebo, a comparative drug? Did they get better? Worse? If this data is not all maintained accurately, the trial results would be invalid," she says.

Clinical trials can take years and run into the millions of dollars, McKenzie says. And patient safety is critical, so the inventory system has to be exact.

There were several challenges with the integration project. "There has never been a single ERP instance developed to support an end-to-end process for both clinical and commercial supply chain management," McKenzie says. "Most software developers don't know how complex things become in a clinical trial."

The various groups involved in the project--including R&D, manufacturing operations, ERP administrators and developers, finance, and quality--had to be educated on the intricacies of integrating clinical requirements with supply chain operations. Amgen also had to be certain that adding the new modules wouldn't affect the performance of the existing global ERP system.

When decision day came, McKenzie says, "we had 22 people sitting around a table, and we went around one by one and said, 'Vote yes or no.' We made the decision to go."

Fortunately, the cutover had no impact on the ERP system. In all, the project took 30 months from start to finish, eight months longer than Amgen estimated at the outset.

So was it worth it? The company didn't calculate the project's ROI, but that doesn't mean the value isn't measurable. "If you ask any of the leaders who are responsible for our clinical trial supply chain whether they would do it again, they would say yes," McKenzie says. "We couldn't meet the clinical trial demands we're running today if we hadn't done this."