IN PARTNERSHIP The future of clinical supply management
Analysis by Aparna Seksaria, life sciences industry solution manager, and Markus Kelbel, business transformation consultant at SAP.
Market overview and unique clinical business requirements
The life sciences industry has been at the forefront in realising that only disruptive innovations are the key to the future of the health of a patient. With digital transformations catching up on commercial business models of pharma and medical devices, the clinical world and biologics, there is a compelling need to integrate patient enrolment all the way until the delivery of therapies. The COVID-19 pandemic has emphasised the fact that, besides accelerated innovations and smooth digital connectivity, adapting to aberrant supply and demand shifts is the need of the hour. Trends in precision medicine, gene therapy, gene editing, and other personalised therapies call for efficient integration of high-touch customer experiences, just-in-time orchestration of demand- driven manufacturing, and site shipment processes. These are significant steps that help organisations plan for the unforeseen. Manual hand-offs and transmission of information over dispersed systems adds complexity to data-staggered clinical businesses. The pressure for zero-tolerance execution only increases after adding the dimension of country- specific regulations. Hence, it is not a matter of if there is a need for building resilient systems, but a matter of when will clinical companies climb on board for this digital journey. In this context, SAP is launching the SAP Intelligent Clinical Supply Management solution, which will lay the foundation for unique and constantly evolving clinical business requirements.
Technology adoption in the clinical world Current clinical business architectures are characterised by a high level of solution diversity, complemented by spreadsheet workarounds. Fragmented systems and processes across the value chain – starting from the initiation of a clinical study to delivery of the kit – have put immense pressure on supply chain and procurement decisions. Lack of integration among clinical manufacturing systems and distribution networks challenge real-time
inventory traceability, which is critical to direct-to- patient (DtP) delivery. Frequent manual interventions between planning and manufacturing systems and interactive response technology (IRT) can result in delayed and erroneous transfer of critical information, such as subject enrolment and change of dosages. Over the past decade, the adoption of clinical trials has increased across the globe, paving the way for multiple contract research organisations (CROs), contract manufacturing organisations (CMOs), and trial execution systems catering to a specific country and region. Lack of drug product visibility at CROs, CMOs, and freight-forward companies can delink the chain of custody from the product manufacturer. With little or no oversight over kit distribution, execution of trials has become an expensive affair. With the advent of multiple partners and adoption of decentralised trials, the proliferation of data points emerging from the initiation of the trial until patient delivery calls for disproportionate emphasis on the adoption of global standards like GS1. Increased adoption of industry-sponsored clinical trials requires not only smooth integration of various IT systems, but also delivery of the drug product at substantially lower costs.
Collaboration and integration as the key To address the challenges mentioned above and help ensure the delivery of a state-of-the-art, globally accepted industry standard clinical solution, SAP has set up an industry consortium. The SAP Intelligent Clinical Supply Management solution has been developed in collaboration with industry thought leaders and more than 20 clinical supplies manufacturers. With inputs from clinical business leaders and their business partners, such as IRT vendors and CROs, the clinical trial supply solution has been created to address the challenges that the industry is currently facing. This customer engagement initiative is defining clinical supply chain management processes and capabilities and helping build an industry standard solution, along with a sizeable team of high-calibre experts from SAP’s life sciences industry business unit and the
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