Rethinking Clinical Trials: Tim Smith on Medable’s Approach to Speed and Efficiency

As the demand for decentralized and hybrid clinical trials rises, Medable Inc. is positioning itself at the forefront of this transformation. Known for its cloud-based platform, Medable has facilitated over 300 decentralized and hybrid clinical trials in 60 countries, serving more than one million patients and research participants. The company’s software-as-a-service (SaaS) model has demonstrated impressive results, with customers reporting 200% faster patient enrollment and a 50% reduction in trial costs. Now, with the launch of Medable Studio, a no-code platform that drastically reduces trial setup times from months to hours, the company is looking to further streamline the clinical trial process.

At the core of Medable's mission is addressing the inefficiencies that have long plagued traditional clinical trials—delays in site activations, complicated vendor hand-offs, and opaque timelines.

Tim Smith, Co-Founder and Chief Technology Officer at Medable, has been integral to this mission, leading the company’s efforts to empower sponsors with more control and transparency. In this interview, Tim sheds light on the challenges in clinical trials, the innovation behind Medable Studio, and the future potential of digital tools in accelerating the development of new therapies.

Andrii: From your perspective, what are the biggest pain points and inefficiencies in traditional clinical trial processes that have been hindering progress for decades? How do these issues impact both sponsors and patients?

Tim: From a technology perspective, even with all the advancements of platforms and digital tools creating decentralized clinical trials, we have still been seeing a lot of implementation bottlenecks and impediments to getting studies live. Traditionally, the process has been cumbersome with multiple roles, hand-offs, and vendors with different timelines. These complexities add risk to trials and can delay site/locale activation and first-patient in. 

Andrii: Medable Studio promises to reduce trial setup times from months to hours. Could you walk us through the specific technological innovations that enable this transformation? What makes Medable Studio stand out compared to other solutions in the market?

Tim: Medable Studio is the first true SaaS self-service platform for building, testing, and launching global studies at scale. While there are other builders on the market, Medable Studio is unique in that it offers everything in one place: eCOA builder, schedule of assessments builder, translation workbench, and cross-study library. These are all accessible in one intuitive interface that’s simple enough for one person to manage the entire process end-to-end. This means fewer stakeholders, hand-offs, and bottlenecks in the process. And where larger teams and partners are involved, Studio gives study teams visibility and control over the process to ensure it isn’t ambiguous or a black box. This allows for study teams to be confident in how their builds are progressing to get the trial launched.

And we are just getting started. Intelligence is baked into Studio’s core which enables important functionality. We have many exciting announcements to come soon on AI enhancements with exciting potential. 

Andrii: Medable Studio suite is described as a 'no-code' platform. How important is the accessibility of such tools for non-technical users in the clinical research field? What kind of feedback have you received from trial teams using these features?

Tim: Industry feedback has been exciting so far. Major pharmaceutical companies have said “Studio is exactly what we are looking for,” and “it’s very easy, simple – a form builder’s dream,” and “an impressive platform.” One customer said it’s a quantum leap in clinical trial technology! This feedback is an important testament to the potential of Studio to transform the landscape. 

It also underscores the importance of our no-code interface. Sponsors and study teams have lacked transparency and control – for instance, they hand off their protocol and wait for go-live, hoping that it’s on time. Studio provides unprecedented levels of accessibility. While some teams will prefer to have the additional control of building themselves, even if Medable is still building studies, teams can easily review the progress in real-time. It creates a much more collaborative and efficient process.  

Andrii: Looking ahead, what do you see as the most promising technological opportunities for improving clinical trials and accelerating the development of new therapies? How do you envision Medable's role in advancing these opportunities?

Tim: We are on the precipice of realizing all that technology can bring to clinical research. Other industries that have benefited from SaaS platform technology, such as Salesforce, which was initially a cloud-based CRM and is now an entire suite for analytics, sales, and marketing. Or even a consumer-based product like Canva, which completely democratized design. It opens the door to innovation and new opportunities. Medable is excited for that degree of progress in clinical research and ultimately to solve long standing bottlenecks towards getting effective and safe therapies approved faster for more people globally. 

Andrii: The healthcare industry is rapidly evolving with the integration of digital solutions. In your view, how will digital platforms like Medable influence the broader healthcare landscape over the next five to ten years? What shifts do you anticipate in patient care and research?

Tim: Digital platforms will be very influential in how biological targets and subsequent medicines are discovered, developed, distributed, manufactured, and delivered to patients. With digital platforms, such as Medable’s SaaS evidence generation platform, easy-to-implement and use interfaces will connect disparate data sources into one place. This translates into faster startup of projects, and faster, deeper analysis of data that will help drive the speed and quality to these insights. I am hopeful that these types of digital platforms will increase the speed of innovation for research and patient care, and that the standard of both will move beyond today’s status quo to let patients be much more of a partner in both research and care.

Andrii: As an entrepreneur in the clinical trial software and data solutions industry, what have been some of the most significant challenges you’ve faced in building and scaling Medable? What grand lessons have you learned about innovation, leadership, and navigating the complexities of the healthcare industry?

Tim: I've learned that staying true to the mission is the most important factor. It serves as the driving force behind solving challenges that often take much longer and are far more complex than anticipated. Secondly, achieving scale is crucial. Disruptive, category-defining technologies possess immense potential for impact, but without the ability to scale, that potential is never fully realized. When impact cannot be achieved at scale, customers can become disillusioned, and the promise of the technology remains unfulfilled. That's why innovations like Studio are vital—they enable us to deliver value at scale, ensuring the meaningful impact we aim for is truly realized.

Topics: Clinical Trials