In this interview, Tim Smith, CTO and co-founder of Medable, discusses the launch of Medable Studio, a no-code platform designed to streamline the process of launching eCOA solutions in clinical trials. The platform promises to reduce setup timelines from months to days, offering greater control, transparency, and efficiency for biopharmaceutical companies. Below, we delve into the features of Medable Studio and how it benefits sponsors.
Moe Alsumidaie: How does Medable Studio ensure data integrity and compliance when non-technical users build and launch trials?
Tim Smith: Medable Studio ensures data integrity and compliance by eliminating the need for custom code when launching a study. This reduces validation challenges and extended timelines. The platform’s inherent configuration capabilities maintain all technical safeguards and end-to-end data flows. Additionally, the visual interface allows users to incorporate quality checks in real-time, ensuring that the study is built correctly.
For example, traditional eCOA solutions often require bespoke development, which introduces code when the study is launched. This necessitates revalidation, extending timelines, and increasing complexity and risk. Medable Studio, on the other hand, eliminates this by providing a no-code environment where all configurations happen within the platform’s guardrails. This ensures that all technical safeguards are inherently maintained, and users can perform quality checks in real-time as they build their assessments, instruments, and workflows.
Moe Alsumidaie: What automation or intelligence features within Studio significantly contribute to time reduction?
Tim Smith: Studio incorporates automation at almost every step of the process. For example, the Schedule of Assessments feature allows users to configure complex workflows with a single click, significantly reducing manual input. The Translation Workbench automates the translation process, reducing bottlenecks. While AI capabilities are not yet exposed to end users, they are baked into the core of Studio and will be rolled out in future updates. These features ensure that expedited processes do not compromise quality or reliability.
Even without AI capabilities currently exposed to end users, the platform’s automation significantly reduces manual tasks. For instance, configuring a Schedule of Assessments in a traditional system might involve thousands of clicks, especially for complex DCT workflows. Medable Studio reduces this to just a few clicks, allowing users to create intricate workflows and interactions between sites and patients effortlessly. Additionally, the Translation Workbench streamlines the translation process, enabling users to manage translations seamlessly and reducing the need for multiple rounds of back-and-forth with vendors.
Moe Alsumidaie: Could you provide insights into these companies’ specific challenges with traditional eCOA solutions and how Studio addressed those issues?
Tim Smith: Traditional eCOA solutions frequently require outsourcing, which can lead to a significant loss of control and transparency for sponsors. This reliance on external vendors often extends timelines and adds complexity to project management, making it difficult for sponsors to maintain oversight and ensure timely progress. Medable Studio directly addresses these challenges by offering a self-service model that empowers non-technical users to manage the entire process end-to-end. Medable Studio allows sponsors to retain greater control and visibility throughout the study build process by reducing the need for constant back-and-forth communication and external project management. This streamlines operations and enhances transparency and efficiency, ensuring clinical trials stay on track and within scope.
Moe Alsumidaie: What measures are in place to ensure sponsors using the self-service model have the necessary support and expertise?
Tim Smith: Medable Studio includes built-in training, certification, and documentation to guide users. Our customer success teams and internal SMEs are available to provide best-practice services for those needing additional support. We anticipate some initial hand-holding but believe that our customers will quickly become proficient in using the platform.
Medable Studio is designed to be user-friendly, with built-in training, certification, and documentation to guide users through the process. Medable‘s customer success teams and internal SMEs are available to provide best-practice services for those needing additional support. This ensures sponsors using the self-service model have the necessary support and expertise to avoid potential pitfalls during the trial design and launch phases.
Moe Alsumidaie: Can you elaborate on how the Translation Workbench integrates with existing localization and translation workflows?
Tim Smith: The Translation Workbench centralizes the entire translation process, allowing users to manage multiple locales and languages from a single interface. It automates the bundling of translation files and provides live previews for quality checks. This reduces the need for multiple rounds of translations, significantly speeding up the process and ensuring cultural and linguistic accuracy. This ensures that translations are accurate and culturally appropriate, significantly speeding up the study setup and design process.
Moe Alsumidaie: How does Medable Studio integrate with other Medable tools like eConsent and Televisit?
Tim Smith: Medable Studio integrates with other Medable tools like eConsent and Televisit. For example, specifying that a visit is remote or televisit-enabled is straightforward and automatically triggers the appropriate functionalities in the patient and site apps. This integration ensures that all aspects of the trial are managed cohesively, improving efficiency and outcomes. While eConsent is not yet directly integrated into Studio, it will be in future updates, further streamlining the process.
Moe Alsumidaie is Chief Editor of The Clinical Trial Vanguard. Moe holds decades of experience in the clinical trials industry. Moe also serves as Head of Research at CliniBiz and Chief Data Scientist at Annex Clinical Corporation.
