Author: Daniela Duffett, Senior Solutions Consultant, Suvoda
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Good clinical trial operations are a critical part of running successful trials. However, the inherent complexities of clinical trials—from novel therapeutics, to hybrid trial designs, to overwhelmed sites and diverse participant groups—can pose challenges to sponsors’ operational standards.
For example, 69% of phase 3 studies underwent at least one substantial amendment in 2022, compared to 66% between 2013-2015.1 eCOA usage in clinical trials grew to 53% in the past two years and is expected to rise to 64% in the next two.2 There’s also a shift towards patient-reported outcomes (PROs), predicted to make up 51% of COAs in the next two years, highlighting the growing importance of patients’ feedback.3
These examples show growing sophistication within clinical trials. They also present an important opportunity for sponsors to harness complexity to advance treatment options for patients who may benefit. This blog shares two examples of how strengthening sponsor-vendor partnerships can improve clinical trial supply chains, data collection, and operations when built upon solid partnership principles.
Sanofi's deep-dive onboarding with Suvoda set a new benchmark for transparency in sponsor-vendor relationships. By fostering open communication from the start of the partnership, Sanofi gained an in-depth understanding of what Suvoda could offer—clarity on capabilities and limitations alike.
The open communication practice made it possible for Suvoda to create the custom integrations Sanofi needed for a seamless transition onto Suvoda IRT, and the collaborative approach meant Suvoda could act as a thought partner rather than just another vendor.
The result? Sanofi achieved ~25% reduction in labor costs during the distribution process.
Cara Therapeutics faced significant delays in previous electronic Clinical Outcome Assessments (eCOA) implementations, leading them to partner with Suvoda for their Phase Ib and Phase II/III chronic pruritis studies across ten countries.
With a focus on enhancing patient eCOA compliance and easing the burden on study teams, Cara Therapeutics required a solution that would not only streamline operations but also improve data visibility and ensure timely study submission.
Suvoda’s infrastructure delivered on all fronts, providing Cara Therapeutics with a more efficient, less burdensome, and easily implementable solution compared to past eCOA studies.
Success in clinical trial operations comes from a deep understanding of the complexities involved in novel therapeutics, hybrid trial designs, and global studies. At Suvoda, we’ve found that the following partnership principles best help us build strong relationships with our customers and other partners, strengthening trial outcomes.
1. Align on goals, vision, and values upfront
Understanding and synchronizing each team’s goals and principles is vital for partnership success. For example, Sanofi’s openness to have an in-depth onboarding with Suvoda enabled a solid alignment between both parties throughout the partnership.
2. Implement governance structures and foster open communication
Building trust through transparency, including the clear communication of capabilities and limitations, is essential for effective collaboration. Suvoda aims to be upfront and transparent about existing system capabilities, which allows clients to have clearer expectations and aids their overall trial planning.
3. Deliver with agility and trust
Reliability in execution and flexibility during unforeseen challenges are traits of a strong partnership. Cara Therapeutics, for example, had highlighted experiences with previous eCOA partners surrounding the lack of transparency on project timelines and execution. Suvoda worked as a single project team, which meant better communication and on-time delivery as everyone worked with the same goal in mind.
4. Adapt technology to fit study needs
Adopting a consultative approach to technology application helps create solutions that are tailored to meet the unique requirements of each study.
5. Reinforce commitment to patients
The ultimate goal is to improve patient outcomes. Effective partnerships not only enhance operational efficiency but also allow us to conduct more patient-friendly trials, potentially speeding up the drug development process and bringing new treatments to patients faster.
Sponsor-vendor collaborations built on a foundation of partnership can be an important first step in conducting a successful trial. This is crucial because as clinical trials become increasingly complex, sponsors need partners who can work with them to achieve their goals and help bring treatments to patients who need them most.
These strategic collaborations play a critical role in navigating operational challenges and accelerating the delivery of innovative treatments to patients. As trials become more sophisticated and patient-centric, the success of these partnerships will depend on shared commitment to innovation, agility, and mutual understanding of evolving healthcare needs.
Daniela Duffett
Senior Solutions Consultant, Suvoda
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