The full name of Edgar’s/my company is Smeets Independent Consultant – SIC. It was established in 2003.

I am a sole trader, in the Netherlands known as ‘ZZP’.

The company is registered with the Dutch Chamber of Commerce (KvK) number:, and is VAT registered.

I operate a few basic SOPs in my office, on the topics ‘Physical and Digital Security’, and ‘GDPR; Preventive and Corrective Measures’.

Services Offered

I offer a fairly straightforward, efficient set of services when setting up your research project/trial, and represent you – my client – when following through during the execution of the trial(s).

I always keep a lean and business-like approach in mind, respecting the Plan-Do-Check-Act cycle. 
The tasks performed by me could be one or more of the following:

    • Selecting sites for your research project, preparing each, setting up logistics, contracts, and applying for regulatory approvals (EC and CA)
    • Central (Statistical) Monitoring, with on-site visits where needed (in line with Risk-based Monitoring approach) (Quality Control)
    • Quality Assurance when setting up your research project (e.g. issue the Monitoring Plan, Data Management Plan, etc., assist with performing a Risk Assessment), or (assisst with) building your Quality Management System (according to ISO 9001:2015)
    • Data Management activities  / Central (Statistical) Monitoring
    • Training/coaching other CRAs/monitors working on the same trial
    • Oversee Safety Reporting, provide follow-up if needed
    • Generally speaking: at least the tasks described under item 5.18 of the E6 ICH-GCP R2 guidelines


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

Zondaghof 58
1335 LD Almere
The Netherlands
E: e.smeets@sic-est.nl
M: +31 6 487 95 102