According to a survey done by Tufts Center for the Study of Drug Development among 194 corporations involved in clinical trials, changes mid-study are the largest headache for these organizations. Every single change takes an average of 30 days to be performed and there is usually an average of 4 planned and 4 unplanned changes in a study.
- The new In Vitro Diagnostic Regulation (IVDR) is mandatory as of May 26th, 2022.
- The acronyms ePRO and eCOA define the tools used to collect data directly from the participants in clinical trials.
- Discover the advantages and inconveniences of these two pseudonymisation methods used in clinical research.
- In clinical trials and studies a large number of data on the participants is required to be stored and managed. Is that clinical data subject to compliance with the GDPR?
- If you need to create an eCRF for your clinical study, let me give you a piece of advice: use an eCRF that allows you to design and configure it through a visual editor.
- If you have decided to use an EDC or an electronic CRF (eCRF) to collect data in your clinical trial, it is important to know what are some of the most important characteristics that you should keep in mind when choosing one.
- The new European Union Medical Device Regulation is mandatory as of May 26th, 2021.