1. How to make mid-study changes as if you had an army of computer scientists but without having to program a single line of code.

    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.
  2. How to be sure to comply with IVDR(EU) when collecting clinical data

    The new In Vitro Diagnostic Regulation (IVDR) is mandatory as of May 26th, 2022.
  3. ePRO/eCOA in clinical trials: 3 keys to save a lot of time.

    The acronyms ePRO and eCOA define the tools used to collect data directly from the participants in clinical trials.
  4. Pseudonymisation in clinical trials: dissociation vs encryption

    Discover the advantages and inconveniences of these two pseudonymisation methods used in clinical research.
  5. Clinical trials and GDPR

    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?
  6. 3 Advantages of using a visual editor to create an eCRF

    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.
  7. The 3 keys to not fail when choosing an eCRF.

    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.
  8. How to comply with the MDR(EU) when capturing clinical data in an electronic format

    The new European Union Medical Device Regulation is mandatory as of May 26th, 2021.