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 'ZZPer'. 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 or CROs to consult on and assist with a variety of tasks within 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.
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 (issue Monitoring Plan, Data Management Plan, etc.
Data Management, nowadays this one could group under Central Monitoring
Train or coach other CRAs/monitors working on the same trial
Basically, 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').
On request, I can send you further information, such as a Curriculum Vitae, a recent copy of my training log, a publication list, my ACRP credentials, or my current or future availability.