About

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: 39.08.30.34, 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

Contact