What are some of the challenges with database builds for medical device studies, given the current regulatory requirements? What are the important items to be aware of? In this post, we will look at these and other questions, with a focus on data management and...
Automation and the Future of Clinical Data Management
Automation in clinical data management (CDM) is becoming increasingly popular due to the increasing volume and complexity of data being generated by clinical trials, as well as the need to improve the efficiency and accuracy of CDM processes. Check out the infographic...
Centralized Risk Reporting, Escalation, and Governance (CRREG) Platform
According to the most recent draft of the International Council on Harmonisation (ICH) Guideline for Good Clinical Practice (GCP) E6(R3), “The aim of monitoring is to ensure the participants’ rights, safety and well-being and the reliability of trial results as the...
Clinical Data Management (CDM) Can Make or Break a Study’s Success
EU MDR: Compliance Requirements From a Vigilance Perspective
Companies attempting to comply with Medical Device Regulation (EU) 2017/745 (MDR), introduced in May 2021 for medical device certification in the EU are challenged by the complexity and scope of the requirements. It is important for medical device companies to...