Climedo for Medical Device Manufacturers
Clinical Trials for Medical Devices and SaMD Made Easy
Climedo helps you to save time and costs, improve data quality, and easily conduct surveys for your medical device studies.
Climedo helps you to save time and costs, improve data quality, and easily conduct surveys for your medical device studies.
Climedo supports medical device manufacturers and software developers across the product life cycle, from clinical investigation to ongoing market surveillance. The platform is built around EU MDR and GDPR requirements.
Collect PMS and PMCF data continuously under EU MDR, using structured forms and automated reminders. Keep evidence on device performance and safety organized for your technical documentation.
Run real-world performance and follow-up studies with electronic data capture and patient-reported outcomes. Reach participants on any device, with all data processed to GDPR standards.
Support Software as a Medical Device, including digital health applications. Capture clinical evidence and patient-reported outcomes to back your performance and benefit claims.
The EU-MDR presents manufacturers with numerous new challenges. Experts believe that in Europe, 10% of medical technology companies are threatened in their existence due to the MDR and that around 30% of medical devices must be withdrawn from the market or cannot be recertified in time.
With Climedo you ensure the performance and safety of your medical devices over their entire life cycle. Benefit from a user-friendly and secure solution for your medical device studies, save time and money and increase your data quality at the same time. With our survey tool, you can carry out simple surveys that your product users can conveniently answer on the device of their choice (smartphone, tablet, computer). All data is processed in compliance with the highest data protection requirements.
ADC
At the center of everything
Everything else builds on it. ADC captures study data from documents, patients and HCPs with near-zero manual entry and feeds every module around it in real time.
See How ADC Works
EDC
Cost-efficient, automated and scalable: Capture data for your clinical studies and surveys electronically with our EDC system – all in one place.
Our EDC SystemeCOA & ePRO
Convenient, secure and fast: Digitally capture all data reported by your patients in the course of a clinical study – on any device and with no app.
Our ePRO SolutionsReal-Time Dashboards
Our interactive dashboards enable you to see real-time visualizations of your clinical trial data and compare patient cohorts across different sites.
Our Real-Time DashboardseConsent &
Televisits
Enrol participants wherever they are: they read and sign the consent on their own device and, when needed, meet the study doctor in a televisit.
Our eConsent & TelevisitsHybrid Trials
Patient-centered and flexible: Combine visits at the site with ePRO and televisits from home, so patients can take part wherever they are.
Our Hybrid Trial Solutions
We'll show you how to start a clinical trial or survey and address your specific needs and desires.
Climedo's intuitive user interface means you'll be onboarded in just a few hours, without the need for programming skills. Get started with your project right away.
Patient centricity and decentralized study designs accelerate your recruitment, with patient adherence above 90% in Climedo studies.
Predefined workflows with complex decision trees including automatic plausibility and validation checks improve the data quality from the time of input.
Achieve significant time savings of up to 49% thanks to reusable form templates and the possibility of decentralized study designs and remote monitoring.
Our cloud-based solution has been tested by state authorities and offers a granular roles and rights assignment for different system users.
Dashboards and smart filter views allow you to view all results in real time and thus anticipate potential problems. Data exports are possible in common formats.
Prof. Dr. Christoph Schmitz
Chief Medical Officer, Auto Tissue Berlin
Christiane Weis, M.Sc
Clinical Department, Gelita Medical
