Publications

I enjoy writing articles or presenting posters that cover developments in the clinical research field.

It goes without saying that I would never make public, any confidential information related to the projects or clients I work(ed) on/for.
Primarily, the developments come from the Dutch or EU clinical trials setting, and this explains why some of the articles are in Dutch..
These articles or posters are ‘Open Access’.
I welcome any comments or suggestions on the topics discussed.

Articles in English

  • 2015. EU Trial Review Changes from Reg 536/2014: The Netherlands. Applied Clinical Trials Online. download
  • 2014. First anniversary of the Dutch free e-learning module ‘Onderzoekswijs’. CRfocus. download
  • 2013. Free-to-Use eLearning Modules. Applied Clinical Trials Online. download
  • 2008. GCP training and certification of research professionals in The Netherlands. CRAdvisor. download
  • 2005. Implementing the EU Directive Update from the Netherlands. CRFocus. download

Poster Presentations in English

  • 2014. A Leaner and More Proportionate Approach to Reporting Risks in Clinical Trials. European Federation of Good Clinical Practice. download
  • 2009. ICRs eLearning Module ‘ICH GCP for Investigators’ – a pilot study. Institute of Clinical Research Conference and Exhibition. download
  • 2009. Training Dutch Academic Investigators – status update and future plans. Institute of Clinical Research Conference and Exhibition. download
  • 2008. Communicating A Negative Trial Outcome – A Dutch RCT Using Probiotics In Severe Acute Pancreatitis. Institute of Clinical Research Conference and Exhibition. download

Presentations about ACTRIS

  • 2020. What is ACTRIS? View the June 2020 presentation
  • a brief (9 minutes) YouTube movie, Edgar presenting ACTRIS from a virtual booth at the MAGI conference, June 2020
  • a brief (8 minutes) YouTube movie, Edgar presenting a walk-through of ACTRIS

Articles in Dutch

  • 2020. Veranderingen op komst door Europese Medische Hulpmiddelen Verordening – Meer klinisch bewijs over veiligheid en prestatie. link
  • 2015. Regeldruk bij patiëntgebonden onderzoek. Nederlands Tijdschrift voor Geneeskunde. download
  • 2013. Raakvlakken tussen Good Clinical Practice en kwaliteitsmanagement principes uit ISO 9001:2008, (h)erkenning kan voordelen bieden. Fiagnostiek. download
  • 2007. Meten is weten. Nederlands Tijdschrift voor Researchverpleegkundigen. download

About S.I.C.

Smeets Independent Consultant - SIC, is the full name of my/Edgar's company, established in 2003. I am a sole trader, in the Netherlands known as 'ZZP'. The company is registered with the Chamber of Commerce (KvK) number: 39.08.30.34, and is VAT registered. I partner with (bio)pharmaceutical companies, start-ups, Institutions, investigators, or CROs to consult on and assist with a variety of tasks within the clinical research field. All my activities are performed using efficient reporting to my clients (risk-based, lean), and sustained by appropriate follow-up. I have a few SOPs in place myself to cover the topics 'Physical and Digital Security', and 'GDPR; Preventive and Corrective Measures', in my home office. You are kindly invited to explore this website, and please DO contact me with any questions.

Services offered

In general I offer a rather straightforward, efficient set of services when setting up your research project/trial, and represent my client when following through during the execution of the trial(s). I always keep a lean, business-like approach in mind.
The tasks performed by me could be one of the following, by itself or combined:
  • Selecting sites for your research project, preparing each, setting up the logistics, contracts, and applying for regulatory approvals (EC and CA)
  • Central Monitoring, with on-site visits where needed (in line with Risk-based Monitoring approach) (Quality Control)
  • Quality Assurance when setting up your research project, build or refresh your Quality Management System (issue Monitoring Plan, Data Management Plan, etc.)
  • Data Management activities / (extended) Central Monitoring
  • Employ ACTRIS (see elsewhere) to manage any issues / potential risks
  • Train or coach other CRAs/monitors working on the same trial
  • Oversee Safety Reporting, provide follow-up if needed
  • Generally speaking, all the tasks described under item 5.18 of the E6 ICH-GCP guideline
    • In general, when submitting your trial to EudraCT, my name and details will get listed at section G5 of 'Annex 1 Clinical trial Application Form' (G5 sub items 1.9, 1.10, 1.11 and 1.13 answered 'yes').

Contact

On request, I can send you further information, such as a Curriculum Vitae, a recent copy of my training log, a publication list, or my ACRP credentials. Please contact me to have a chat, and to find out my current or future availability.

e.smeets@sic-est.nl
© 2024 Smeets Independent Consultant.