Close-out visits
Close-out visits represent the final phase of a clinical trial, During these crucial visits, our experienced clinical monitors conduct a comprehensive evaluation of trial documentation, data integrity, and regulatory compliance.
Our Approach:
Data Integrity: We ensure the accuracy and completeness of trial data, conducting final checks to confirm its reliability for analysis.
Regulatory Compliance: Our close-out activities strictly adhere to Good Clinical Practice (GCP) guidelines and regulatory requirements, ensuring a fully compliant trial.
Documentation Excellence: We review all trial documentation, ensuring that it is in order and ready for submission to regulatory authorities.
Patient Safety: We conduct a final assessment of patient safety and adverse event reporting, leaving no safety concern unaddressed.
Timely Issue Resolution: We work closely with site staff and investigators to address any pending issues promptly, ensuring that all matters are resolved before trial closure.
Transparent Communication: Open and transparent communication is maintained throughout the close-out process to keep stakeholders informed.
Let’s keep in touch!
Get the latest news about GCT and the projects we support in a monthly email. View the mailing archive