Investigator Initiated Studies and academic projects
Investigator Initiated Studies (IIS) and academic projects
We are able to provide various services for IIS or non-profit research institute projects, organized in a dedicated devision called Clinical Operations WCN (COW). Within our network, we pride ourselves on a high level of dedication as we share the goal of conducting the best quality in research. All services are provided in accordance with regulatory requirements and ICH-GCP.
Offering scientific expertise from protocol design to study publication. As physicians and experienced trialists, various members have ample experience seating in steering committees or advisory boards providing scientific expertise.
Effective project management is essential for successful study execution. Our project managers have extensive experience in clinical research and are committed to deliver study milestones.
Taking care of competent authority and ethics applications for both intervential (Dutch WMO act) and observational studies.
We practise risk-based trial management. Clinical monitoring is done in compliance with ICH-GCP guidelines, our SOP’s and local regulatory requirements to ensure subject safety, data quality and protocol adherence. Monitoring scope and frequency may vary based on study design.