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 ‘ZZP’. 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, 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 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 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 the Monitoring Plan, Data Management Plan, etc., assist with performing a Risk Assessment)
    • Employ ACTRIS (see elsewhere) to manage any issues / potential risks
    • Data Management activities  / (extended) Central Monitoring
    • Training/coaching 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 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 training logs, a publication list, my ACRP credentials, or my current or future availability.

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