Karin van Dort

psiXchange is a system which can be used for the automated distribution of e.g. safety reports and clinical trial documents by connecting contact data, source documents and country regulations. Responsibilities include managing outsourced safety reporting via psiXchange, providing expertise in regulatory requirement for safety reporting (post-marketing and clinical trials), provide input for process and system improvement and maintaining customer relations

Team lead of the cross-functional team responsible for the distribution of safety information to ethical committees/IRBs and investigators in clinical trials. Responsibilities.

Responsible for the implementation of the Clinical Study Team tools to enable trial overview and the implementation of distribution of safety information to Data Monitoring Committees within the CESAR system. Responsible for project management for the implementation of a data management tool (Medidata Rave)

As Manager Safety Reporting, I was responsible for the development of an automatic system for reporting of safety information to investigators and ethics committees, including the processes around this new system. This system ensures automatic sending and tracking of all safety information. The development is done in co-operation with a vendor. With the implementation of this system, we have made a significant cost reduction and efficiency as well as gained transparency in the safety reporting compliance.

Responsible for the setup, collection and reporting of metrics and KPIs, enabling participation in benchmarking programs and KPI dashboards. Main achievements and responsibilities include: - Establishing Clinical Operations KPI dashboards - Establishing the Vendor Relationship metrics including a tool to obtain feedback on the relationship between sponsor and vendor - Participation in different benchmarking programs (CMR, KMR

Responsible for the review of processes within Clinical and the quality check of 2 major trials.

Coordination, site selection, initiation, monitoring and close-out activities of phase I-III clinical studies (local project management) including responsibility for budgets.

• Served in Bihar, India on behalf of the Institute of OneWorld Health (now merged with PATH, received grants from the Bill & Melinda Gates Foundation, based in San Francisco, USA) • Working together with hospitals to implement GCP guidelines in a different cultural and underdeveloped environment in preparation to a new study in visceral leishmaniasis