For one global biopharmaceutical company, the ability to access vital data when and where it’s needed can affect more than just performance — it can impact the ability to save lives. This industry leader develops, manufactures and distributes breakthrough medical therapies to treat patients with serious and life-threatening medical conditions. The company conducts clinical trials to better understand the effectiveness of pharmaceutical and medical treatments.
Managing clinical trials and the supply of medications can be complex, particularly when several trials are occurring simultaneously. The company tracks multiple variables from disparate systems, including which medications are being tested, how many sites are conducting clinical trials, which patients need to be placed in or removed from a trial, and how much of a medication needs to be manufactured at a given time. The company also monitors shipments between distribution centers and whether medications need to be destroyed because they are near expiration or were compromised during shipping or in the warehouse.
Loss of visibility into data at any point in the clinical trials process can have a serious impact on the outcome of a trial and can even invalidate a trial if a patient misses a dose. The company uses several systems to track variables, gain insights and manage the process, including a clinical trial management system, SAP ECC® (Enterprise Central Component), SAP S/4HANA®, SAP BW on HANA®, and multiple Interactive Response Technology (IRT) systems.
The company partnered with Protiviti to improve its data management and analytics processes. It wanted to reduce unnecessary manual effort and gain traceability and a comprehensive view of critical data. It also wanted to integrate data from its disparate systems and produce visual reports showing the end-to-end clinical trials supply process, including planned vs. actual enrollments, supplies, and production of medication, as well as traceability of data between systems and financial data to comply with the Physician Payment Sunshine Act.
With easy access to data, integration of its multiple systems, and on-demand reporting, the company can focus on its most important mission — developing and delivering innovative medical therapies to improve and save lives.
Because the company was already using SAP HANA’s in-memory database, Protiviti proposed modeling the data in a virtual layer on HANA. This would eliminate the need to duplicate or store data, reducing storage costs and creating speed and efficiency in reporting, while allowing for quicker development time and easier maintenance than conventional or older analytics methodologies.
The project team, using its in-depth SAP technology expertise and strong understanding of clinical trial methodology and structure, enabled the organization’s leadership to evaluate and refine difficult requirements to better align with the company’s processes.
The new data management, analytics and reporting solution gives the company better visibility into its inventory throughout the clinical trials cycle. Clinical trial managers can know when and where a medication is in the pipeline, see stock levels at a clinical trial site, and know if a medication is nearing its expiration date and needs to be replaced. The solution makes it easier for the company to enter and track data needed to comply with regulatory reporting requirements, creating transparency and eliminating tedious and time-consuming processes. And the system’s design allows it to evolve as the company’s needs change, to provide access to even more information. The improved visibility into the company’s clinical trial supply process directly impacts patient safety, providing the company with better tracking and less waste of clinical trial medications and a more efficient clinical trial process overall.