EU: EMA supports digital health technologies in clinical trials
Digital health technologies are becoming increasingly relevant for the conduct of clinical trials. As a demonstration, the European Medicine Agency (EMA) recently established an Innovation Task Force, “a multidisciplinary group that includes scientific, regulatory and legal competences […] to provide a forum for early dialogue with applicants on innovative aspects in medicines development.”
Some examples of technologies deployed in clinical trials include patient monitoring for clinical parameters, digital/remote monitoring of drug intake, electronic signatures on consent forms, and direct data entry by clinicians into caserecord forms.
Meditrial understands the industry and how to make the most of advanced technologies. For this reason, we offer innovative digital solutions to empower your clinical trials:
To manage and control your study, Meditrial’s innovative team brought you cloud-based complete data management system Catchtrial. All in one CRF, Data Validator, Report Builder, Core Lab images and Safety Adjudicator to build your global trials.
Catchtrial is ready to support worldwide medical research by capturing clinical trial data and images with instant, advance and on-the fly translation cloud-based platform for every stakeholder associated with your study. Catchtrial is free for COVID-19 studies.
Meditirial’s Catchtrial ePRO is compliant, secure and intuitive solution to track complete patient data. It includes user-friendly Forms builder interface with easy data saving options. Catchtrial ePro is fully integrated with eDiary for automated daily, weekly and monthly patient data capture and with EDC for a real-time desktop access of the patient-reported data.
Meditrial’s Catchtrial electronic Patient-Reported Outcomes (ePRO) app facilitates better interaction between the patient, investigator and Sponsor by analyzing the status of patient’s health directly received from patient.
Find out more about our digital solutions!
Read more about the EMA regulatory perspective on digital health technologies for clinical trials.
Contact Meditrial for immediate assistance in Europe or the US.
Free Helpline +1-800-901-4286
Table of Contents
Getting a CE mark for medical devices: a step-by-step guide
Practical guidance on the CE mark for medical devices under EU MDR, from classification and evidence to conformity assessment and EUDAMED
A Practical RBQM Framework for Medical Device Trials
Risk-based quality management for medical device trials, with practical actions for risk assessment, monitoring, data review, and trial oversight
EU Breakthrough Medical Devices Under MDCG 2025-9 (BtX)
EU breakthrough medical devices gain a clearer regulatory pathway under MDCG 2025-9, with early advice and lifecycle evidence planning
What Swissmedic Fast-Track Means for Clinical Trial Sponsors
Swissmedic swissethics Fast-Track Pilot Project accelerates eligible trial reviews and makes coordinated regulatory preparation increasingly important.
FDA Breakthrough Device Acceleration
How innovative MedTech companies can accelerate FDA approval, secure Medicare coverage, and reach patients faster—starting with Breakthrough Device Designation.
The contribution of patient associations in clinical trials
Historically, patient organizations have had the primary purpose of supporting the communities they represented. Today, this remains a crucial function, but modes have changed, as has the role that associations and patients themselves take on [...]
This article provides general information and does not constitute regulatory or legal advice. Requirements should be confirmed for the specific study, applicable regulatory framework, and markets concerned.
