The realm of clinical research has been deeply changed, mainly the way we collect and manage data, with the surge of Electronic Data Capture (EDC). This system plays a pivotal role in unlocking real-world evidence (RWE) by making data collection…
The medical device field is always evolving and post-market clinical follow-up (PMCF) has become a critical area of focus for manufacturers. A PMCF Plan is a paramount technical document that highlights a method for conducting Post Marketing Clinical Follow Up…
Distinction between ePRO vs eCOA Electronic Clinical Outcome Assessments (eCOA) and Electronic Patient Reported Outcomes (ePRO) are two types of methods of data gathering in clinical trials. They appear similar, although there are crucial differences between them. eCOA is a…
The Healthcare landscape has been facing unprecedented evolution, and monitoring and evaluating the safety and effectiveness of medical products is pivotal. The FDA has long recognized the importance of collecting real-world data and evidence to inform regulatory decisions and improve…
For many types of medical devices – particularly those at the lower end of the risk scale, Direct Data Capture from subjects in their home setting (DDC, also often referred to as eSource) can provide more meaningful and comprehensive real-world…
Clinical research benefits immensely from the increased use of digital tools to enhance efficiency, and to enable decentralized clinical trials (DCTs) to happen. DCTs count on remote participation of patients, which can be very convenient, but it also means that researchers may…
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