Services phase I-IV studies

  • Feasibility
  • Site selection
  • Pre-study visits
  • Initiation visits
  • Organization of start-up meetings
  • Monitoring visits (remote and on-site)
  • Drug accountability
  • Close-out visits
  • Set up and maintenance of the study file
  • CA submission
  • Central and local METC submission
  • Contract negotiation with sites and/or vendors
  • Writing of (country specific) patient information and informed consent
  • Writing /review of standard operating procedures
  • Design Study specific forms
  • Development patient recruitment plans
  • Audit preparation
  • GCP training, including European clinical trial directive and Dutch legislation
  • SOP training
  • Coaching
  • Co-monitoring and training visits

About SCRC

In more than 20 years, I have collected a lot of knowledge of clinical operations. The processes, (e-) tools, people, teams, institutions, rules, regulations and  do’s and don’ts. In all my assignments I bring this knowledge with me and I am happy to share it and to learn more from others. I believe in development of organizations, teams and individuals. I also believe that this can happen when things are shared and discussed in a constructive way. I’m offering an active ingredient to knowledge sharing and development.

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Address: Verlengde Hoogeveensevaart 96, 7864 TC, Zwinderen. The Netherlands.

Phone: +31 615522608.|
KVK: 70814724
BTW nr: NL150840524B01