All my activities are performed using efficient reporting to my clients (risk-based, lean), and sustained by appropriate follow-up.
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, and keep on top of your project/trial
- 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 R2 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’).
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.
1335 LD Almere,
M: +31 6 487 95 102