eCOA
DCT Digital Week: Creating the Digital Foundation for Scale in Clinical Development
Learn how sponsors and CROs can improve their clinical trial conduct by developing new strategies that create sustainable, repeatable, and effective clinical conduct.
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.
Case study: Optimizing choice, flexibility and outcomes with Patient-First Data Collection for Oncology
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.
Enhancing oncology clinical trials through the use of digital technologies
In this webinar, VP of Digital Trial Solutions Musaddiq Khan, VP of Product Strategy Colin Weller, and Cancer Survivor Lindsey Matt discuss how Medable is supporting a patient-first approach in complex Oncology clinical trials
How to design patient-friendly and inclusive 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.