Future Assignments

NEWS on 17 July 2024:

I have room on my agenda to take on new assignments. Can this be your chance to work with me?

-> Please reach out to have a chat to look at opportunities. e.smeets@sic-est.nl 

I keep an eye on current ‘best practices’ and future developments.

Currently, the topics of my interest are

  • Risk Based Quality Management: how can Centralised Monitoring (more specifically Statistical Data Monitoring) be used to flag systemic issues that can be tackled in time so to avoid them becoming hazards/risks.
  • How will EMA’s CTIS portal work out?
  • What practical changes will revision 3 of ICH GCP E6 guideline bring about?
  • Using the open source eCRF software LibreClinica (LC) in my clients’ trials remains attractive. Not only for its rather low operational costs. Since a few years, I partner with an independent data manager / LC expert, so that LC can be offered in conjunction with monitoring services to any interested party.