Emerging trends in clinical trials: Improving clinical operations with an efficient industry standard software
During the last decades, modern medicine has made many advances, and delivered a wide variety of treatments to help patients overcome disease and achieve a better quality of life. However, every new treatment (medication, vaccine, device, or procedure) developed and brought to the market must be assessed for its effectiveness, safety profile including side-effects, and superiority compared to current treatments. This assessment is performed through a clinical trial where a potential treatment is tested with a group of human volunteers in order for the treatment to be approved for wider use in the general population. A clinical trial can be complex, take a considerable amount of time (up to 7 years), and must follow various rules and regulations to ensure compliance with ethical standards or standards that are imposed by regulatory institutions.
Unsurprisingly, this comes with high costs. Studies estimate that costs can be between $48 million and $2 billion to bring a new treatment to market and latest trends in study design considering personalized medicine increase costs even further. While the number of trials is increasing, trials are becoming smaller but with a complex trial design and with more competitive patient enrollment. Adding to that, the COVID-19 pandemic led to increased and shifting demands which drastically affected clinical supply processes, mainly by accelerating and magnifying already existing problems such as missing visibility, resilience and digitization of supply chains.
With the need for better supply chains having been illustrated in such a rigorous way, life science companies should now seize the opportunity to evaluate more robust technology solutions.
In addition, several industry trends are impacting the future of clinical trials:
- new types of clinical trials e.g., cell & gene therapies (vein-to-vein, batch size “1”, cold chain monitoring)
- decentralized and virtual clinical trials with remote patient monitoring
- direct-to-patient deliveries
- emerging technologies, such as smart packaging, electronic labelling
- collaborative innovation and integrated supply chain networks
Overall, the life science industry is facing various challenges and will need to reimagine the clinical trials process to evolve their business models to keep up with these market dynamics and trends. The current IT landscape for clinical trials is fragmented and includes multiple small, customized solutions. Apart from long implementation times and rising maintenance costs for these custom solutions, their incompatibility with other systems in the clinical trial supply chain adds manual steps, loss of efficiency, and additional costs.
For software providers, this is an opportunity to reimagine the clinical trial supply process and take full advantage of emerging technologies to address some of the challenges highlighted above. Key questions include how a software solution can help to
- improve the trial process for patients, companies, and clinicians while at the same time improving its outcomes.
- ensure sufficient supplies while reducing inventory overages.
- design and deploy a next generation clinical trial management solution that allows quick and flexible responses to future trends, while at the same time reducing TCO and overall costs.
- work with partners with industry-leading solutions to complement the software solution to further support the life science customers’ clinical trial goals.
As an answer to these questions, SAP and Tenthpin, together with an industry consortium led by Roche and 30+ customers have developed a new industry standard software solution: SAP Intelligent Clinical Supply Management. This solution leverages the power of SAP S/4HANA with a dedicated industry cloud technology to address the market needs of life sciences organizations for flexible, integrated, and efficient clinical trial supply management. It helps life sciences companies gain end-to-end visibility of clinical supplies, from planning to production to patient. By addressing the above-mentioned industry trends with new technologies, this new SAP solution enables innovation that will help reduce cycle times, optimize inventory levels, and adapt faster to the changing needs of patients and trials.
SAP Intelligent Clinical Supply Management consists of several modules covering the whole clinical supply chain: From study management, to planning and forecasting, manufacturing & packaging, distribution and dispensing of the medication to the study subject.
To give a full insight into the capabilities and the key differentiators of SAP Intelligent Clinical Supply Management, we will publish a blog series covering each of the single modules of SAP Intelligent Clinical Supply Management in the next weeks.
If you are interested in learning more about SAP Intelligent Clinical Supply Management, please be invited to follow the new tag “SAP Intelligent Clinical Supply Management”. We are also happy to receive your feedback, questions or thoughts about SAP Intelligent Clinical Supply Management in a comment.
Stay tuned for new blog posts about SAP Intelligent Clinical Supply Management in the next weeks!