The objective of monitoring clinical research is to ensure that:
- the rights and well-being of the subjects are protected
- the data from the research that is reported are accurate and verifiable in source documents
- the execution of the study is in accordance with the applicable protocol, Standard Operating Procedures (SOPs), ICH-GCP E6(R3), European Clinical Trial Regulation (EU CTR), General Data Protection Regulation (GDPR), The Medical Research Involving Human Subjects Act (Wet medisch-wetenschappelijk onderzoek met mensen, WMO), ISO14155 and with the relevant legal requirements
PhaseUp supports the study starting with the selection of institutions and the submission of the study. This is followed by initiation of the institutions and support during the study. This also includes all interim monitor visits with the associated reporting, up to and including the close out of the study.