Introduction: In the fast-paced world of clinical trials, efficiency and innovation are paramount. As the industry continues to evolve, the need for more streamlined processes has become increasingly clear. Enter Medable Studio—a groundbreaking no-code platform designed to transform how clinical trials are built, tested, and launched. By offering a user-friendly interface and powerful tools for trial management, Medable Studio is not just changing the game; it’s setting a new standard. In this Q&A, Tim Smith, Co-Founder & Chief Technology Officer at Medable, shares insights on how Medable Studio is revolutionizing clinical trial execution, from reducing timelines and costs to enabling decentralized and hybrid trials.
Tim Smith, Co-Founder & CTO of Medable
Q: How do you see Medable Studio changing the traditional timeline for launching eCOA Plus in clinical trials?
Smith: Medable Studio revolutionizes trial timelines by shifting from a full-service to a self-service model, or a combination of both. This reduces stakeholder hand-offs and bottlenecks, allowing a single individual to build, test, and launch a study end to end. The platform’s reuse capabilities mean validation chains remain intact across studies, and the frictionless design eliminates manual steps, significantly reducing the timelines for eCOA builds and launches. We aim to eventually achieve a one-day study launch.
Q: What are the most significant advantages of a no-code suite like Medable Studio for biopharmaceutical companies, particularly in terms of time and cost efficiency?
Smith: Medable Studio simplifies the build-test-launch process, allowing smaller teams to operate at scale. The platform is user-friendly, requiring no coding or design knowledge, which gives control back to trial sponsors and enables CROs to build and launch studies without the bottlenecks of additional vendors. This speeds up the process, especially during protocol changes, which occur an average of 2.5 times per trial according to our research with Tufts CDCC. Studio’s reusable library and translation bench further save time and costs.
Q: Given the industry’s reliance on professional services for study builds, how does Medable Studio’s transparency and control benefit sponsors and trial teams?
Smith: Medable Studio offers live status and review of all study content and processes, providing unparalleled transparency. Study teams can easily track the build state of any instrument, test it live, and monitor the status of translations and other critical elements from a single view. This transparency ensures that trial builds are on track, giving teams confidence in their progress.
Q: Medable Studio is described as having an intuitive no-code interface that allows non-technical users to build and launch trials. How important is this feature for increasing accessibility in clinical trial management?
Smith: The no-code interface is crucial for increasing accessibility, as it allows non-technical users to build, test, and launch studies without needing extensive training. This accessibility empowers experts in patient and site experience to contribute directly to study builds, ensuring that designs are both protocol-fit and optimized for reducing burden and speeding development. The global scalability of this process is another significant benefit.
Q: Can you elaborate on the significance of the Point-and-Click Builder and Visual Schedule of Assessments Builder in simplifying the trial design process?
Smith: These tools make the complex trial design process intuitive. For example, Studio’s schedule of assessments builder allows for quick configuration of complex schedules and interactions between patients, sites, and their activities, with instant visual confirmation. This ensures that the trial design is both correct and complete, streamlining the overall process.
Q: How does the Translation Workbench in Medable Studio address common bottlenecks in global clinical trials, and what impact might this have on the overall trial timeline?
Smith: The Translation Workbench allows existing translations to be instantly available within a study and bundles new or modified strings for seamless sharing with translation vendors. The live preview capabilities enable early detection of potential issues, eliminating the need for additional rounds of translation or localization testing. This significantly reduces timelines and costs associated with translations.
Q: In what ways do you believe Medable Studio will set new benchmarks for clinical trial execution and contribute to the broader shift towards decentralized and hybrid trials?
Smith: Medable Studio enables rapid implementation of decentralized and hybrid trials, overcoming the bottlenecks traditionally associated with study design and implementation. By removing eCOA from the critical path and facilitating the integration of decentralized and hybrid elements, Studio improves ROI, shortens study completion timelines, and enhances participant diversity, setting new benchmarks for the industry.
Q: How might the scalability and efficiency gains provided by Medable Studio influence the future of evidence generation in clinical trials?
Smith: Medable Studio modernizes evidence generation by integrating cloud, AI, and real-world evidence collection technologies. This transformation accelerates timelines to submission and improves the quality of the evidence itself, ultimately speeding up drug development.
Q: What trends do you foresee emerging in clinical trials as platforms like Medable Studio become more widely adopted?
Smith: We anticipate a significant shift from manual efforts to technology-driven processes in clinical development. Currently, 90% of resources are deployed to manual efforts, but with the adoption of platforms like Medable Studio, this ratio could invert. The result would be a tremendous reduction in overall costs and a radical improvement in timelines.
Q: With impressive results like 200 percent faster enrollment and 50 percent cost reductions, how does Medable Studio compare to traditional methods in delivering ROI for Phase II and Phase III trials?
Smith: While we’re still gathering data, the early results are promising. Medable Studio enables study builds and launches in a single day, far exceeding traditional timelines. This technology reduces the friction and delays typically associated with launching trials, making it a non-factor in the process and enhancing ROI.
Q: How do you anticipate Medable Studio’s introduction will impact Medable’s market position and customer adoption rates moving forward?
Smith: Medable has always been seen as an innovator in the industry, and with Studio, we are scaling our innovation. The platform will allow most clinical trials to incorporate protocol-fit digital solutions, improving operations and reaching more diverse participant populations. This will likely boost our market position and customer adoption rates.
Q: What future enhancements or additional functionalities can we expect from Medable Studio, and how will these innovations continue to transform clinical trials?
Smith: We are continuously developing new Studio capabilities that leverage the latest technologies to accelerate the availability of effective therapies to patients. Expect ongoing innovations that will further streamline clinical development and contribute to our mission of increasing the number of drug approvals.
Q: What strategic steps is Medable taking to further advance its mission, as mentioned by Michelle Longmire in her social post?
Smith: Our current release of Studio reduces timelines to study start-up, and we will continue to innovate across the clinical development lifecycle. Our goal is to significantly increase the number of drug approvals each year by bending the time-cost curve and accelerating the journey to major improvements in human health.
Q: Medable will be showcasing Studio at the upcoming DPharm Conference. What specific features will you be highlighting during the live builder demonstration, and what feedback are you anticipating from industry professionals?
Smith: We’re excited to demo a live build on stage at DPHARM in just 10 minutes, showcasing Studio’s ease of use and user-friendly design. We’ve already received enthusiastic feedback from customers who have previewed Studio, and we expect to replicate that excitement with a broader audience at the conference.
Conclusion: Medable Studio is setting a new standard in how clinical trials are conducted. By making the process more accessible and efficient, it’s helping to bring new therapies to market faster. This platform isn’t just about technology—it’s about giving teams the tools they need to manage trials more effectively, reduce costs, and ultimately, improve patient outcomes. As Medable continues to grow and evolve, it’s clear that this is just the beginning of a major shift in the way clinical trials are run.
Thank you to everyone that contributed to this article:
- Tim Smith, Co-Founder & CTO at Medable
