Future of Clinical Research
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What is eCOA? An overview of eCOA in Clinical Trials
What is eCOA?
As FDA Principal Deputy Commissioner Janet Woodcock said in a 2015 Clinical Outcome Assessment Public Workshop, “It turns out that what is really bothering the patient and what is really bothering the doctor can be radically different things...patients are true experts in their disease.”
Clinical outcome assessments (COAs) have been key to capturing a comprehensive picture of patient experiences and treatment outcomes in today’s research landscape for decades. Integrating COAs into trial protocols bolsters our treatments' scientific integrity and enhances our ability to understand the real impact of interventions on patients.
COAs (called eCOAs when captured electronically) are essential to understanding whether a drug reduces symptoms, improves patients’ quality of life, and improves their ability to perform activities they care about.
Since the mid-2010s, electronic clinical solutions, like eCOA, have rapidly replaced their paper counterparts. Electronic Clinical Outcome Assessments comprise systematized digital methods for capturing patient-centered outcomes in clinical trials. These systems utilize validated electronic interfaces to collect, store, and analyze patient-reported data, clinician observations, and performance metrics.
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DTRA 2024: GSK and Medable discuss change management and DCTs
On Friday, November 15, 2024, the Decentralized Trials & Research Alliance (DTRA) held a fireside chat between Brandon Maggio, GSK’s Global Head of Digital Operations & Process Optimization, and Alison Holland, Medable’s Chief Customer Officer. They were gathered to discuss the evolving landscape of decentralized and digital clinical trials and how best to drive change management in an era of continual changes within trial research. The following blog is a summary of their discussion.
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Leveraging eCOA to improve patient adherence in clinical trials
Discover how advanced eCOA platforms improve patient adherence, ensuring reliable data and faster trial completion. Explore real-world successes, including adherence rates exceeding 90% in diabetes and oncology studies, powered by Medable’s eCOA (electronic clinical outcomes assessment) solutions.
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How eCOA vendors drive innovation in clinical trials
Discover the transformative role of eCOA (electronic clinical outcomes assessment) vendors in modern clinical trials. From seamless integration and AI-driven analytics to patient-centric design, learn how leading platforms like Medable’s eCOA+ enhance efficiency, compliance, and data quality.
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The Future of decentralized clinical trials: Opportunities and adaptations for Medable
Traditionally, clinical trials have relied heavily on centralized sites and face-to-face interactions between researchers and participants. However, the limitations of this model have become increasingly apparent, especially during the COVID-19 pandemic, which prompted an unprecedented emergence of decentralized clinical trials (DCTs), whose characteristics of remote patient engagement, virtual assessments, and mobile health technologies allowed the healthcare industry to continue drug development (albeit at a slower pace). As the healthcare landscape continues to evolve, DCTs are emerging as a vital component of the clinical research ecosystem. By leveraging technology and data to streamline processes and the need to enroll a greater diverse patient population, DCTs promise enhanced patient engagement, improved data quality, and accelerated study timelines. As with everything in life, nothing is always that simple. In this blog, we will explore the future of decentralized clinical trials and look at the challenges faced by sponsors, sites, and patients when planning, implementing, and running a DCT. We will also discuss how Medable is continuously adapting its platform and software capabilities to reduce risks and provide solutions that allow the benefits of DCTs listed above to be fully realized.
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SaaS’ advancements unlock new possibilities in clinical research
The rise of SaaS has transformed industries, including life sciences, by enabling new possibilities. For instance, Salesforce revolutionized how organizations managed their customers and future clients with its cloud-based software, enhancing accessibility and collaboration. Similarly, Canva made graphic design tools accessible to all, empowering professionals and casual users alike.
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How platforms solved clinical trials’ disparate data problem across eCOA, eConsent, and more
Our world is drowning in data.
Humanity generates a staggering 402.74 million terabytes of information every day. From the countless videos we stream to the endless social media scrolling, our global digital footprint is growing exponentially. This data deluge is reshaping industries, influencing our lives, and posing unprecedented challenges.
Within clinical trials, rapidly evolving technologies are enabling researchers to capture new data points as trials grow more complex. However, this poses new challenges in managing clinical trial data.
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Rapid evolution: Clinical trials have gone digital
DCT and digital elementsare now the new normal. But what exactly does "digital" or "decentralized" mean in the context of clinical trials?
A panel of industry experts from Sanofi, Bayer, and the Clinical Trials Transformation Initiative (CTTI) recently came together to discuss the evolution of DCTs and share their experiences.
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Control and transparency: Solving sponsors’ key challenges in eCOA development and study launch with Studio
There’s no doubt that study launches come with extremely high stakes for sponsors requiring precise coordination over numerous critical activities across multiple stakeholders, including regulatory bodies, ethics committees, investigator sites, and internal teams. Now, sponsors can see exactly what’s happening live across assessments, instruments, translations, and more. This is true whether their internal teams handle launch activities or whether vendors handle them, a stark contrast to the traditional technology development process.
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What is SaaS, and how are life science companies using it today?
In today's digital age, Software as a Service (SaaS) has emerged as a cornerstone of cloud computing, transforming how businesses and individuals access and utilize software applications.
This cloud-based software deployment model has become increasingly popular due to its accessibility, cost-effectiveness, and scalability. Now, SaaS is making significant inroads in the pharmaceutical and life sciences industries, offering solutions to longstanding challenges and driving innovation.
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Evidence & Insights: A Data-Driven Exploration of Decentralized Elements and Digital Trial Technologies
In Medable’s first edition of Evidence and Insights, you’ll get an in-depth look at our research investments and collaborations exploring the effects of DCTs and clinical research technology. Through strategic partnerships and continued investment, we’ve spearheaded efforts that redefine industry standards and set a new precedent for the evidentiary basis of technology’s impact on drug development.
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Experts discuss AI’s future in pharma
In June of 2022, Open AI forever changed the world’s technological landscape with the release of ChatGPT 3.5. The explosion and proliferation of AI tools have become a focal point of interest and curiosity in almost every industry, with commentators in pharma wondering how AI can improve clinical research.
In January 2024, panelists from Syneos, Obvious Ventures, Sapphire Ventures, IDEA Pharma, and GSR Ventures joined Medable’s CEO, Dr. Michelle Longmire, to discuss the purpose, potential, and power this transformative technology offers.
Here’s what they had to say.
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2024 Predictions: Digital Advancements in eCOA and Clinical Trials
As we look ahead to 2024, the landscape of clinical development is poised for significant advancements in digital and artificial intelligence. As leaders in clinical outcome measurement and innovation, our team at Medable is mission driven to continue to accelerate clinical development timelines with transformation technology.