eCOA
Real-time clinical trials are here. Medable was built for them.
Real-time clinical trials are here. Medable's continuous trial management platform gives sponsors the evidence generation, agentic AI, and regulatory-ready infrastructure to run clinical programs at the speed the FDA now expects.
The Definitive Guide to Digital Evidence Generation
According to Grandview Research, the hybrid and decentralized clinical trial (DCT) market will be worth more than 12 billion dollars by 2030. Sparked by the COVID-19 pandemic of 2020, the rapid ascent of patient-centered technology and the digital and decentralized trials they’ve spawned has forever changed the landscape of clinical conduct. Sponsors are increasingly turning to DCT platforms in alignment with the rise of Life Science and Software-as-a-Service (SaaS) solutions. For those who haven't made the jump yet, there are many questions, including "What is a decentralized clinical trial?" Find out with this in-depth guide to decentralized clinical trials. Uncover how they work, their benefits, and how they transform clinical development.
eCOA Digital Week: An honest assessment of eCOAs from a site perspective
Joe Dustin, VP/GM of eCOA and Annie Hesslewood, Site & Patient adoption lead at Medable host an open discussion with a panel of sites and CRAs to provide a candid assessment of how upcoming changes in the eCOA landscape can reduce burden on participants and sites to maximize the chance of success in clinical trials.
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Medable perspective: Three points on FDA eCOA guidance
At the beginning of April 2023, the FDA published a draft of the fourth in a series of Guidance Documents entitled “Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments (COA) Into Endpoints For Regulatory Decision-Making”. Once finalized these four documents will be combined and will replace the 2009 Guidance, “Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims”. Part 3, which was released in draft in June 2022, provides advice around the development and validation of new COA (including the modification of existing COA).
Back to Basics: What is a decentralized clinical trial?
In a decentralized clinical trial, part or all of the protocol occurs away from the primary study site. Instead of patients traveling, often repeatedly, to a central site for enrollment, consent, data collection or symptom monitoring, they can participate in telehealth visits from their homes, often using familiar technologies, like smartphones, tablets and wearables to transmit pertinent information. Even medications and devices can increasingly be delivered directly to a patient’s home, and a home visit from a health care professional can be arranged if necessary.
Leverage novel options in oncology clinical trial design to reduce burden for patients and sites
Flo Mowlem, Senior Director, eCOA Science & Solutions shares insights on how electronic solutions, with a focus on patient-reported outcome (ePROs) can reduce burden on participants and sites to maximize the chance of success in oncology clinical trials.
Use case: Implementing digital solutions to improve oncology trial experience & efficiency
A top 10 pharmaceutical company looked to Medable to streamline participant burden and enhance site and team experience in oncology trials, while establishing a scalable template for future trials in oncology and other areas.
Deploying a patient-first framework to accelerate recruitment & reduce overall trial timelines
Learn how to utilize digital data-flow designs in clinical trials to improve patient diversity and inclusion, increase operational efficiencies, enhance patient enrollment, engagement, and retention, and realize financial value.
ePRO Case study: Better options and outcomes oncology trials.
Medable worked with a top 5 pharma company to increase the safety of patients as anti-cancer treatments may cause pulmonary toxicity, ranging from asymptomatic radiological changes to respiratory failure, and is considered a common side effect.
Actionable data: How to deploy & use patient-centric data collection to improve patient experiences & sharpen decision making
Medable's Gillian Livock, SVP/GM Digital Solutions and Sean Connelly, SVP, Product Management, join Antoine Pivron, Head of Health Solutions EMEA at Withings, to discuss the industry's move toward patient-first data collection, how to increase operational efficiencies, enhancing the patient experience in clinical trials using data, and how to use data insights to drive key decision-making.
Designing patient-friendly ePRO instruments
This blog explores why patient-centric ePRO instrument design is critical to driving study success, provides tips on how to make instruments more patient-centric, and offers resources for additional ePRO design guidance.
White paper: The foundations of decentralized clinical trials
Understand the benefits of web-enabled research tools and how they work.
Development of a mobile health app (TOGETHERCare) to reduce cancer care partner burden: Product design study
Research looking at mobile apps and how they may provide a meaningful access point for all stakeholders for symptom management.