Publications

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 '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.

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 (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').

Contact

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.