Study Close-Out and Final Delivery
We complete each study through a precise and transparent close-out process, ensuring full traceability and audit-readiness in compliance with the highest quality standards, including ISO 9001, ICH-GCP, and ISO 14155. This guarantees that the study meets all ethical, safety, and quality regulations required for a successful close-out and submission to regulatory authorities.
Site Close-Out Visits
Conducting visits to participating sites to verify protocol compliance and ensure proper closure of trial activities.
Electronic Trial Master File (eTMF)
Organization and maintenance of the electronic trial master file, ensuring secure access and regulatory compliance.
Audit-Ready Documentation Delivery
Preparation and delivery of all relevant documentation, ensuring completeness and readiness for regulatory inspections or external audits.
Final Study Report Preparation
Drafting the final study report, summarizing results, key findings, and observations for official submission.
Formal Documentation Transfer
Formal handover of all study documentation to the relevant parties, ensuring traceability and proper custody.
Data Analysis and Statistical Plan
Analysis of collected data according to the approved statistical plan to generate robust and reliable scientific conclusions.
Do you have any questions?
Send us your message and we’ll get back to you as soon as possible.
