A better look at your data
Build COAs, connect with sensors, and access all your data streams with an intuitive web-based platform for better decision making and submission-ready results.
Seamless, compliant, and timely study startup for sponsor and CRO study teams.
- Build eCOA both validated instruments and eDiaries to industry standard
- Store instruments, including translations, in your library for rapid deployment that scales across future studies
- Dashboards and reports to stay up-to-date with all study and participant activity
- Access and integrate a global library and marketplace of instruments, digital endpoints, and other trial tools
Connected and convenient
Make data collection a breeze with devices, diaries, and sensors designed to fit into participants’ everyday lives.
Remove manual entry and configuration time with intuitive and automated workflows for sites and study teams.
Get the complete picture
Stay closer to your trial and make quicker, more informed decisions with expanded data sources and an aggregated view of evidence generation.
See your trial’s progress at a glance with easy-to-use dashboards and reporting.
Global expertise and compliance
Rest assured, our standardized, pre-validated builds have undergone scientific review to meet eCOA best practices.
Available in 60+ countries and 120+ languages, Medable’s Data Collection from anywhere is designed to comply with all global regulations, including FDA 21 CFR Part 11, ICH E6 (R2), and GDPR.
“Our eCOAs are designed, built, and implemented with user experience at the forefront."
VP Therapeutic Area Solutions - Customer Value Team
Implementing Digital Solutions to Improve Oncology Trial Experience & Efficiency
Download our latest use case to read about how a top-10 pharmaceutical company implemented platform solutions to improve their oncology trial experience and efficiency.
Frequently asked questions
eCOA stands for electronic clinical outcome assessment and uses electronic devices like tablets, desktop computers, and phones to collect data from trial participants. Participants complete diaries, questionnaires, or other prompts to communicate how they are feeling or functioning during the course of a clinical trial. eCOAs are part of the decentralized clinical trial (DCT) methodology and are essential to understanding whether a drug is reducing symptoms and improving patients’ quality of life.
Medable’s eCOA offering is part of our broader evidence generation offering: Patient-First Data Collection. Medable’s tools allow teams to build eCOA instruments (both validated instruments and eDiaries) that meet industry standards. Data collected from this system can be used for primary endpoints in pivotal studies. Study teams can store instruments, including translations, in a library for rapid deployment in future studies. Dashboards keep teams informed of all startup activities along the way. Teams may also access their library of prebuilt, validated instruments to improve study startup.
Yes. Medable's platform is multimodal, meaning patients can access our interface through the Patient app or a web browser. A BYOD model allows patients to use their own smartphone or other device for data capture during a site visit or remotely. Participants using devices they are already familiar with may lead to better compliance and ultimately, a better clinical trial experience. However, since some participants may be hesitant to download an app on their own device, or may not own a device that meets the requirements, it’s important to anticipate a percentage of provisioned devices, even in trials adopting a BYOD strategy.
Yes, Medable has a partnership with Withings who offers a range of medical grade and compliant devices. Adding protocol complexities like connected sensors and wearables will effect the study build time.
Medable's scalable solutions provide pathways to collect and assess objective and subjective patient data in a comprehensive, compliant, and standard manner allowing sponsors to discover clinically meaningful insights in real-time. And our web-based patient application provides a more patient-centric experience via seamless in-app reminders and task notifications, decreasing the likelihood of dropouts, inconsistent and inaccurate data and missed patient visits.
The latest in eCOA
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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.