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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Get In Touch
Address: Verlengde Hoogeveensevaart 96, 7864 TC, Zwinderen. The Netherlands.
Phone: +31 615522608.|
Email: gracielle@schutjens.com
Website: www.schutjens.com
KVK: 70814724
BTW nr: NL150840524B01