Frequently asked questions
Decentralized clinical trials (DCTs) refer to clinical trials that use digital technology to facilitate the remote conduct of several aspects of a clinical trial, such as patient recruitment and consent, data collection, monitoring, and more.
DCTs can involve the use of various technologies, including mobile devices, wearables, telemedicine, and electronic data capture, to enable participants to take part in the trial from their homes or other non-traditional settings. DCTs offer several benefits, including increased patient participation, reduced costs, and improved data quality.
Our product is a cloud-based, API-agnostic platform that includes a patient app, site app, study builder, and data warehouse. We have many offerings across therapeutic areas and digital capabilities including eConsent, TeleVisit, eCOA/ePRO, and remote monitoring. What is unique about Medable is our tools are not just point solutions, but connect to form a larger, unified platform, that can work within your clinical trial ecosystem. In fact, the Medable platform can become part of your tech stack, to easily scale up to add additional capabilities, studies, or TAs when you are ready.
We also have an extensive partner network to enhance your study with additional capabilities such as tokenization and connected sensors, all supported by our change management partners. To learn more or ask about a specific project or portfolio implementation, please request a demo.
Pricing varies largely depending on the scope and complexity of your study, its capabilities, its locations, and how many studies you’d like to enable on our platform. Customers find the most efficiency and future value by working with us on multiple studies across your portfolio. To inquire about pricing please book a demo with our team.
The timeline for setting up a study can vary depending on its scope and scale. However, the simplest study can be launched within just 5 weeks. Since the timeline is protocol- and study-dependent, if you have any specific questions, we recommend speaking with one of our SMEs. Our experts will be happy to answer any questions you might have.
We offer a variety of capabilities including eConsent, featuring wet and digital signature support, ePRO diaries, eCOA libraries, a fully-integrated TeleVisit, a top-rated participant app, a study manager tool with reporting & dashboards, and the ability to connect to validated sensors and wearables. Visit our specific offerings for more information or request a demo with our platform experts.
Yes. Medable’s products are designed to conform to FDA 21 CFR Part 11, HIPAA, and GDPR requirements.
To date, our product has been deployed in 115 languages across 60+ countries. We also have capabilities such as wet-ink and digital signatures to accommodate different countries’country’s signature requirements.
While a mobile app is not required, our top-rated participant app is available on both iPhone and Android and provides added convenience for participants. For example, particpants can access their trial information and remotely fill out diaries throughout the trial as long as they have an internet connection.
The Medable platform is also web-enabled and available on any browser.
This means that sites can set up televisits with participants, as well as send notifications and reminders whiles tudy teams can see compliance and participation in real-time while having complete oversight into their study progress from one dashboard.
Data collected from multiple sources, devices, and systems is housed and stored in CDISC or similar data format* so it is ready to be put into CSR and TFLs for submission to FDA and other agencies.
Yes, the Medable platform is designed to be interoperable and seamlessly integrates with hundreds of external services and workflows across IRT, EDC, CTMS, EMR, Labs, EDW, and Custom Systems to deliver a singular system that stewards data and streamlines clinical trial development.
Sponsors, sites, and study teams each use tools within the platform, like eCOA and eConsent to complete core trial tasks.
We offer a 24/7 support network for both participants and sites.
We also have a team of clinical trial experts to help shape your protocol to best practices and a full delivery and site support team dedicated to ensuring your trial runs smoothly.
Medable offers customers full-service assistance in study design, implementation, and study management.
Additionally, our Patient Success team offers reviews of trial conduct, protocol, sensors, wearables, and more to help ensure your participants receive the best experience possible.
Medable has a one-of-a-kind patient caregiver network– the first team of its kind. Our PCN improves the experience of patients and caregivers by facilitating equitable, inclusive, and diverse clinical trials that elevates the experience of study participants. Most importantly, they work with clinical trial participants and caregivers for user feedback to help shape the products Medable creates.