Knowledge Center

By Tim Smith, Co-Founder & CTO,Medable

In today’s rapidly evolving tech landscape, vibe coding is opening up exciting opportunities by blending human expertise with smart agents to give every engineer incredible leverage and productivity. This new approach invites us to embrace innovative tools that drive greater scale and impact. But it’s not enough to just pick up new practices—success demands a significant mental shift and a change in approach. Developers must move beyond their traditional roles as individual contributors and evolve into “agent managers.” This means blending deep technical expertise with the strategic oversight of a manager, actively coaching intelligent agents so that each interaction builds on the last and contributes to a cohesive, scalable solution.

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When talking to customers conducting their first multi-country trial, we sometimes liken clinical trials to spider webs. Just as a garden spider’s web differs from a black widow’s, clinical trials follow unique patterns in every region. Each country comes with its own set of rules, ethical standards, approval processes, and data privacy laws. Cultural factors also play a crucial role in how patients are recruited and understand Clinical trials, requiring sensitive communication and a deep respect for participants’ needs.

In Japan, these regulatory and cultural intricacies form a complex ‘web,’ with anchor points and structural requirements that, when understood and implemented correctly, create a framework for success. However, conducting Clinical trials in Japan has historically posed challenges for Sponsors and Contract Research Organizations (CROs). When we first entered the region, one Sponsor consistently cited issues with eCOA solutions and site and patient support, not fully adapting to Japan’s unique requirements. This feedback, combined with our own experiences on the ground, revealed a clear need for improvement.

Today, we can proudly say that the solutions we put in place have transformed Japan’s Clinical trial landscape, and what was once a challenge has now become the “gold standard” for supporting Clinical trials in the region.

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Electronic Clinical Outcome Assessments (eCOA) have revolutionized data collection in clinical trials, offering convenience and real-time insights that traditional methods cannot match. 

However, the effectiveness of these digital tools hinges on the quality of the daily experience they offer participants. Read below to see direct feedback from patients and caregivers across multiple conditions in our Patient Champion Network (PCN), as we identify ten critical factors that can improve the eCOA experience.

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A top-10 global pharmaceutical company partnered with Medable for their pivotal Phase III diabetes study in the highly competitive market. Recognizing the inefficiencies in traditional study delivery and closeout processes, the company leveraged Medable’s expertise to accelerate timelines, enhance operational efficiency, and achieve a faster time to market for this high-profile therapy.

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When OpenAI unveiled ChatGPT in November 2022, it ignited unprecedented interest in artificial intelligence. Three years later, generative AI and machine learning have caused seismic shifts in industries worldwide. The pharmaceutical industry is not left out of this shift, with Roots Analysis reporting that they expect AI within clinical trials to grow at a compound annual growth rate of 16% through 2035. This growth is driven by belief in AI’s unique ability to process and analyze massive datasets at groundbreaking speeds, identifying patterns and generating insights that would be impossible to discover through traditional methods. By leveraging these capabilities, pharmaceutical companies hope to fundamentally reimagine core aspects of clinical trials, from initial design through final data analysis.

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A top-10 global pharmaceutical company aimed to address eCOA adherence and patient enrollment challenges faced by clinical trial sites and participants in Japan.

Recognizing Japan’s distinct regulatory, cultural, and logistical landscape, the company partnered with Medable todevelop an initiative to enhance the region’s patient and site experience.

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Deployment of remote and virtual clinical trial methods and technologies, referred to collectively as decentralized clinical trials (DCTs), represents a profound shift in clinical trial practice. To our knowledge, a comprehensive assessment of the financial net benefits of DCTs has not been conducted

Research looking at mobile apps and how they may provide a meaningful access point for all stakeholders for symptom management.

Electronic clinical outcome assessments (eCOA) have become essential for modern clinical trials, offering numerous advantages over traditional paper-based methods. However, the benefits of eCOA can only be fully realized if the data collected is of the highest quality. Ensuring data quality in eCOA clinical trials requires a multifaceted approach, encompassing platform design, patient engagement strategies, robust data validation procedures, and strict adherence to regulatory guidelines. This blog post explores key strategies for achieving and maintaining data quality throughout the eCOA process.

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In the rapidly evolving landscape of oncology clinical trials, the integration of electronic Clinical Outcome Assessments (eCOA) and wearable technologies is revolutionizing how data is collected and patient experiences are monitored. These technologies offer unprecedented opportunities to enhance data quality, improve patient engagement, and enable real-time tracking of treatment efficacy and side effects. This blog post delves into the pivotal roles that eCOA and wearables play in modern oncology clinical trials, highlighting their impact on patient-centric research and the advancement of cancer care.

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Explore the prevalent challenges encountered in eCOA clinical trials, from technical issues and patient adherence to data security and regulatory adherence, and discover strategies for mitigation.