About

Smeets Independent Consultant – SIC, is the full name of Edgar’s/my company, established in 2003. I am a sole trader, in the Netherlands known as ‘ZZPer’. The company is registered with the Dutch Chamber of Commerce (KvK) number: 39.08.30.34, and is VAT registered.
I partner with (bio)pharmaceutical companies or CROs to consult on and assist with a variety of tasks within the clinical research field.
All my activities are performed with efficient reporting to my clients (risk-based, lean), and sustained by appropriate follow-up.
You are kindly invited to explore this website, and please DO contact me with any questions.

Services Offered

In general I offer a fairly 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 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 Monitoring, with on-site visits where needed (in line with Risk-based Monitoring approach) (Quality Control)
    • Quality Assurance when setting up your research project (issue Monitoring Plan, Data Management Plan, etc.)
    • Data Management, nowadays one could group this under ‘(extended) Central Monitoring’
    • Training or coaching other CRAs/monitors working on the same trial
    • Generally speaking: all the tasks described under item 5.18 of the E6 ICH-GCP guidelines

In general, when submitting your trial to EudraCT, my name and details will get listed in 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 my Curriculum Vitae, a recent copy of my training log, a publication list, my ACRP credentials, or my current or future availability.

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Address:
Zondaghof 58,
1335 LD Almere,
The Netherlands
E: e.smeets@sic-est.nl
T: +31 36 532 59 34
M: +31 6 487 95 102