Future Assignments

NEWS on 17 July 2024:

I have room on my agenda to take on new assignments. Can this be your chance to work with me?

-> Please reach out to have a chat to look at opportunities. e.smeets@sic-est.nl

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I keep an eye on current ‘best practices’ and future developments.

Currently, the topics of my interest are

Risk Based Quality Management: how can Centralised Monitoring (more specifically Statistical Data Monitoring) be used to flag systemic issues that can be tackled in time so to avoid them becoming hazards/risks.
How will EMA’s CTIS portal work out?
What practical changes will revision 3 of ICH GCP E6 guideline bring about?
Using the open source eCRF software LibreClinica (LC) in my clients’ trials remains attractive. Not only for its rather low operational costs. Since a few years, I partner with an independent data manager / LC expert, so that LC can be offered in conjunction with monitoring services to any interested party.

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 'ZZP'. 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, 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 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, build or refresh your Quality Management System (issue Monitoring Plan, Data Management Plan, etc.)
Data Management activities / (extended) Central Monitoring
Employ ACTRIS (see elsewhere) to manage any issues / potential risks
Train or coach 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 guideline

Contact

On request, I can send you further information, such as a Curriculum Vitae, a recent copy of my training log, a publication list, or my ACRP credentials. Please contact me to have a chat, and to find out my current or future availability.

e.smeets@sic-est.nl