In a recent episode of RTSM Time, host Paul Hughes, Director of RTSM at Johnson & Johnson, sat down with Chuck Harris, Co-Founder and COO of Korio, to tackle a critical challenge facing the clinical trials industry: how do sponsors and RTSM software providers effectively collaborate on emerging requirements?
The Innovation Paradox: Balancing Stability with Progress
The fundamental tension in RTSM is clear: providers seek predictability to ensure quality and compliance, while sponsors need to innovate to advance clinical research. Whether it’s implementing adaptive trial designs, managing complex supply chains, or enabling decentralized trials, this push-pull between stability and innovation affects every clinical operations team.
Breaking Down the Sponsor-Provider Challenge
While standard RTSM functionalities like screening, randomization, and basic supply management are well-established, new requirements demand a different approach. As Hughes points out, sponsors often struggle to effectively partner with providers when implementing novel functionality. The natural tendency is to jump straight to solutions – a pathway that Harris warns against, emphasizing the need to understand requirements holistically before diving into implementation.
Real-World Lessons: DCT and Beyond
This challenge became particularly evident during the pandemic’s push for decentralized clinical trials (DCT). The rush to implement direct-to-patient shipments and decentralized solutions revealed how hasty implementation of new functionality can leave critical gaps in real-world scenarios. Harris and Hughes both emphasize a crucial principle: RTSM is not a “junk drawer” or a “Swiss army knife.” Success comes from understanding its core purpose and appropriate application, particularly when integrating with other systems or implementing new workflows for personalized medicine trials.
Form Follows Function: The Requirements-First Approach
The path forward? It starts with sponsors clearly understanding and articulating their processes and requirements. As Hughes emphasizes, successful implementations rarely come from simply purchasing off-the-shelf solutions. Instead, success stems from sponsors and providers walking through requirements together, ensuring solutions align with actual operational needs. “Form follows function” becomes the guiding principle – understand what you need before determining how to deliver it.
Practical Steps to Successful Implementation
Practically speaking, this means establishing a true partnership built on trust and open communication. Harris outlines a comprehensive approach that includes:
- User journey mapping to understand how sites, supply managers, and other stakeholders will interact with the system
- Detailed data flow analysis from entry point through various integrations
- Early identification of edge cases and potential operational challenges
- Workflow mockups and sandbox testing with actual end-users
- Early engagement with sites and CROs to ensure buy-in and usability
While this thorough approach might seem time-consuming, it actually accelerates implementation by preventing surprises during UAT and ensuring smooth site adoption. The key is building these steps into your process from the start.
The Bottom Line
The message is clear: successful implementation of new RTSM functionality isn’t just about technical capability – it’s about partnership. When sponsors clearly articulate their operational needs and providers feel empowered to ask questions and suggest alternatives, the result is solutions that truly serve their purpose while maintaining regulatory compliance and operational efficiency.
At Korio, we understand that implementing new RTSM functionality requires more than just technology – it demands a collaborative partnership focused on understanding your unique clinical trial needs. Our approach combines industry expertise with a commitment to working alongside sponsors to develop solutions that truly fit their operational requirements.
Schedule a demo and see how Korio gets you Ready for the Trials Ahead™.