Preparing for the European Medical Device Regulation (EU MDR)
Understand how the European MDR (EU MDR) will impact medical device manufacturers and what you can do to prepare.
Put participants first with electronic consent tools that help explain and illustrate what participation means for them. You can use eConsent to reach patients where they are, in whatever way they prefer, on their favorite devices.
Welcome to the future of patient consent. Paper-based informed consent forms (ICFs) aren’t effective. Your clinical trials need an electronic consent solution that will enhance your recruitment efforts and support retention – they need Medrio eConsent.
It was very easy to use Medrio’s system. In less than two weeks, and after just a couple of calls with the Medrio implementation manager, I felt comfortable creating and deploying eConsent on my own.”
Lucia Cesnakova, DiMe Program Lead
Electronic consent does more than eliminate the need for paper forms. It lets you meet trial participants where they are. Remote consent capabilities give patients the space to absorb and ask questions, while multimedia features help them learn what a clinical trial has to offer and what risks they are taking.
It has been fantastic, and so far the best solution I have seen from any eConsent vendor...Overall, it's been fairly easy for sites and patients to use. It adds a lot of value to our studies, and it takes away barriers.”
Study Lead, global clinical genetic testing company
Easily create and modify electronic ICFs for better patient understanding than paper-based consent forms. Our eConsent lets you pick what works best for your participants.
Images, video content, quizzes, and FAQ sections engage patients, boost comprehension, and support retention of information.
ICF version tracking and oversight expedites sharing of revised ICFs and participant re-consenting.
Have confidence in regulatory submission with EU-compatible and 21 CFR Part 11-compliant eConsent.
Capture paper or electronic ICFs at the same time, in the same study, using the same workflows.
Adding multimedia, remote-capable eConsent will help your trial participants fully understand what participation will mean for them, leading to higher rates of patient engagement and retention later on.
Understand how the European MDR (EU MDR) will impact medical device manufacturers and what you can do to prepare.
Discover how the EU MDR is already impacting companies and learn what you can do to prepare for its full release.
Discover how Medrio CDMS/EDC, eCOA/ePRO, and eConsent supported Swing Therapeutics in securing FDA clearance.
Informed consent is a journey – for patients and their caregivers as well as study teams – rather than a mundane procedure of simply gathering signatures. A robust eConsent platform can be built to address participant concerns and answer questions while being extremely cost-effective.”
Tina Caruana, MSc, MBA, Medrio Subject Matter Expert – eClinical Solutions
Keep track of compliance trends and adverse events without waiting for an electronic assessment to be fully completed.
Using our integrated system, we are able to capture and securely store your clinical trial’s electronic source (eSource) data.
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