Amaury Jeandrain
Collaboration between vendors is critical to the success of clinical trials. In a recent webinar, industry experts from Clinigen, N-SIDE, and Suvoda explored how effective partnerships between vendors can significantly enhance clinical supply chain management. They also addressed how sponsors and CROs can maximize the benefits of their vendor partnerships. This blog post highlights key insights from that discussion, revealing strategies to optimize clinical supply chains through strategic vendor collaboration, from the initial Request for Proposal (RFP) to the end of the trial.
The Evolving Clinical Trial Landscape
The clinical trial landscape has rapidly evolved over the past decade. As trial designs become more innovative, drug supply shortages continue, and patient recruitment grows more challenging, more complexities are being introduced into clinical studies.
Clinical supply chain management is more than just logistics; it involves a complex network of processes, from planning all supply chain activities to sourcing drugs and optimizing inventory levels. Moving trial drugs from point A to point B is a far more complex puzzle than it might seem.
Sponsors, CROs, Clinical Supply Chain Management Vendors, IRT/RTSM providers, and Planning & Optimization Solutions providers today are more interdependent than ever. The success of a clinical trial depends on the strength of the collaboration between these stakeholders. Through close collaboration, vendors can identify the most ideal supply chain strategy, maintain transparent communication with all stakeholders, streamline processes, and tackle unforeseen challenges effectively. This co-operative approach ultimately helps get the right medication to the right patient at the right time.
For such a collaboration to succeed, it needs to be handled efficiently from the first synopsis of the clinical trial design to the last patient's involvement in the trial.
In this article, we’ll discuss how a strong partnership can amplify the unique capabilities vendors offer to help manage clinical supplies more effectively. We'll share insights from Henk Dieteren, Clinical Supply Solutions Consultant at Suvoda; Amaury Jeandrain, Strategy Expert, Clinical Supply Chain at N-SIDE; and Stéphane Petit, Senior Director Business Development, Clinical Supplies Management at Clinigen, as they recall joint projects, challenges, and the exciting outcomes of their years of collaborating.
Vendor Selection
The foundation of a successful clinical trial generally begins with selecting fit-for-purpose vendors through an RFP process. This critical phase involves CROs and sponsors evaluating potential partners who best meet their specific trial needs. According to our experts, the key to an effective RFP process is transparency and communication.
Understanding Vendor Capabilities
During the RFP phase, our speakers highlighted three important considerations:
- Select the right capabilities: Each trial is unique and requires a specific set of vendor capabilities to run the supply chain as efficiently as possible. N-SIDE emphasized the importance of quantifying the impact of specific capabilities or decisions, which can easily be done through simulations.
- Set up the right integrations: Suvoda highlighted the importance of a vendor's technological capability to integrate data transfers seamlessly.
- Create the right processes: Each vendor has a defined role. Making sure that roles and responsibilities are clear, and that standard operating procedures are well-defined is crucial for efficient collaboration.
Vendors like N-SIDE, Clinigen, and Suvoda frequently collaborate, and thus have standardized integrations and collaboration processes. Through simulations, we have demonstrated the capacity to reduce the clinical supply chain costs by up to 40%.
Trial Design & Set-Up
Once vendors are selected, the next critical phase is trial design and setup. Involving vendors early in the process enhances their ability to optimize critical supply chain decisions.
Early Involvement for Maximum Impact
Involving vendors like Clinigen, N-SIDE, and Suvoda early in the trial design phase allows influence over key decisions, such as protocol design, country selection, and supply chain strategy. The webinar included examples from N-SIDE demonstrating that small protocol changes could reduce the clinical supply chain budgets by 40%. Vendors can also assist in selecting appropriate depots, other additional services like just-in-time packaging, and the effective configuration of IRT systems.
Optimizing the Supply Chain
Vendors can use their expertise to identify potential savings in supply chain management. For example, using IRT data to predict demand and manage stock levels accurately helps sponsors avoid shortages and overstock situations, reducing waste and costs.
In the webinar, Clinigen shared a case where planning in advance avoided drug shortages to their partner.
Vendors are not just service providers, but experts in their fields. Using them as advisors, sponsors and CROs can generate a lot of value for their clinical trials.
Ongoing Trials: Managing the Unexpected
Clinical trials seldom proceed exactly as planned. Even the best-designed supply chains may face unforeseen challenges. Effective risk management and the ability to adapt quickly are essential to keep trials on track.
Detecting Issues Early
One of the main benefits of collaboration between vendors is the ability to detect issues early and respond swiftly. Real-time data integration between IRT systems and planning software allows vendors to monitor the trial's progress closely.
By comparing forecasted demand with real-time data, any discrepancies can be identified immediately, allowing quick adjustments to supply strategies. This proactive approach enables planning systems to recommend updated supply chain strategies based on real-time events, which are then implemented by clinical supply management and IRT vendors.
Case Study: Managing a Drug Shortage
Strong collaboration allows for a rapid response when things go wrong. For example, in the event of a shortage, having direct access to each other without always involving the sponsor speeds up the resolution process.
During the webinar, the speakers shared how quick communication between Clinigen, N-SIDE, and Suvoda helped to swiftly navigate complex situations.
Another compelling example shared during the discussion involved an oncology trial where a critical drug was in shortage worldwide. Through close collaboration, the team identified a combination of solutions that avoided 400 missed patient visits while keeping the trial timelines and patients' treatments on track. Though N-SIDE optimized and simulated the risk mitigation strategy, they mentioned that optimization is only theoretical until partners such as Clinigen and Suvoda can actually make it happen.
What the Future Holds
The future of clinical trial management is likely to involve even greater automation and enhanced collaboration. Our experts foresee several key trends that will shape the industry.
Increased Automation and AI
Automation will play a crucial role in managing clinical trials more efficiently. Artificial Intelligence (AI) could help predict potential supply chain disruptions, optimize resource allocation, and reduce manual interventions. However, for AI to be reliable—and thus valuable—a significant amount of data is needed; Vendors must be prepared to handle and analyze large datasets securely and efficiently.
Easier Vendor Collaboration
There is a growing trend towards simplifying the process for sponsors to work with multiple vendors. Rather than relying on a single vendor approach, sponsors increasingly prefer engaging with vendors that are experts in their fields. Future collaborations could involve more flexible contracting arrangements that allow sponsors easy access to optimal vendors for each specific need, while minimizing the contractual burden.
Personalized Services and Continued Partnerships
Long-term partnerships between sponsors and vendors are likely to become more common. By collaborating on multiple trials, vendors provide more personalized services, leverage collective experience, and enhance trial outcomes. This continuity can reduce time-to-market, minimize costs, improve patient outcomes, and reduce the carbon footprint of clinical trials.
Unlocking the Potential of Strategic Vendor Partnerships
The clinical trial supply chain is a complex ecosystem requiring coordination among multiple stakeholders. Fostering strong partnerships, involving vendors early, valuing them as trusted advisors, and enhancing collaboration help maintain and improve clinical trials’ efficiency, cost-effectiveness, and success. The experiences shared by Clinigen, N-SIDE, and Suvoda in this webinar demonstrate that when each vendor is allowed to lead in their area of expertise, clinical supply chain performance improves significantly.
The secret to a successful clinical supply chain is seamless collaboration. As the clinical trial landscape continues to evolve, building strong, integrated partnerships will be more important than ever.
About the companies
Clinigen Clinical Services brings 25+ years of clinical supply expertise and industry-best cycle times to help accelerate your drug development journey with comprehensive solutions in clinical supplies management and biological sample management. Clinigen offers primary and secondary packaging and labelling, comparator drug sourcing, warehousing and global distribution, returns, reconciliations, destruction, QP Services, biorepository, and biological sample storage and logistics. For more information visit clinigengroup.com and follow Clinigen on LinkedIn.
N-SIDE is a deeptech company that empowers organizations in the life sciences and energy
sectors to make better decisions and optimize the use of critical resources. N-SIDE combines deep clinical supply chain expertise with advanced mathematics packaged into easy to use and cutting-edge solutions to streamline your clinical trials: accelerate plans, mitigate risks and curb drug waste. For more information and up-to-date news, you can visit n-side.com and follow the N-SIDE Life Sciences LinkedIn page.
Suvoda is a global clinical trial technology company specializing in complex, life-sustaining studies in therapeutic areas like oncology, central nervous system (CNS), and rare diseases. Founded in 2013 by experts in eClinical technologies, Suvoda empowers clinical trial professionals to manage the most urgent moments in the most urgent trials through advanced software solutions delivered on a single platform. Headquartered outside Philadelphia, Suvoda also maintains offices in Portland, OR, Barcelona, Spain, Bucharest and Iasi, Romania, and Tokyo, Japan. The company’s Net Promoter Score (NPS) consistently exceeds the technology industry average, contributing to the company being selected by trial sponsors and CROs to support more than 1,500 trials across 85 countries. To learn more, visit suvoda.com. Follow Suvoda on LinkedIn.
Co-authors
Henk Dieteren
As Clinical Supply Chain Solutions Consultant, Henk has been assisting Suvoda with his knowledge in various areas of clinical trial supply management since October 2020. Prior to joining Suvoda, Henk co-founded the clinical supply chain department at Grünenthal GmbH (Aachen - Germany) and served as Associate Director of this department for 10 years. At Grünenthal, Henk developed operational processes and promoted risk management procedures to establish the company as a clear market leader in the area of the clinical trial supply chain.
Following his time at Grünenthal, Henk moved to BioNTech S.E. (Mainz - Germany) where he assumed the role of Senior Investigational Medicinal Product Manager. At BioNTech, he streamlined data processing in the clinical supply chain for personalized oncology therapies.
Henk is an innovative expert in IRT, temperature excursion management and direct-to-patient logistics and a member of the DtP sub-team of the GCSG Regulatory e-Team.
Stéphane Petit
Stephane Petit has a Master in Business Management (HEC) from Liège University and a Post-Master (DES) from the European Management School in Swansea, Wales. From 1997 to 2007, he held various business development positions mainly in IT and Business Intelligence. In 2008, he had the opportunity to enter the Clinical Research area through an EDC company.
Since then, Stephane further developed his experience in the Clinical Research sector at companies specialized in clinical services such as CRO, Biobanking and ePRO/eCOA, ECG/Respiratory/Imaging. In 2012 he joined B&C Group, a Clinical Trial Supply company, as Business Development Director. In this position, he contributed to the rapid growth of B&C Group, which led to 2 acquisitions: CSM (2016) and Clinigen Group (2018) where he now has the role of Senior Business Development Director for Europe. Since 2017, Stephane is also a board member of BeCRO (Belgian CRO Association) and President since April 24. BeCRO empowers its members to foster Belgium as a leading country for clinical research through continuous innovation, advocacy, and networking.
