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 the closure of all trial activities and confirm they have been completed correctly and in accordance with established procedures. During this stage, the general status of the study at each site is reviewed, the resolution of pending tasks is verified, and the correct management of materials, documentation, and clinical records is evaluated.
eTMF Electronic Archive
Administration of the electronic Trial Master File (eTMF) using an organized, secure documentary structure aligned with international regulatory standards. We handle the classification, updates, and control of essential study documentation to ensure availability and traceability at all times.
Delivery of audit-ready documentation
Preparation and delivery of all relevant study documentation to ensure it is fully ready for external audits, regulatory inspections, or internal quality reviews. Our approach enables a swift and structured response to review requests, minimizing risks and facilitating regulatory evaluation and quality control processes.
Final Report Preparation
We prepare the project’s final report, integrating the obtained results, most relevant findings, and key observations during its development in a clear and orderly manner. Each report presents an interpretive analysis of the results, conclusions, methodological aspects, and any other relevant information that facilitates its review, interpretation, and presentation to the scientific community.
Formal Documentation Transfer
We perform the official delivery of all documentation generated during the study to the corresponding parties, maintaining proper organization, integrity, and accessibility of the files. This process includes traceability mechanisms, documentary control, and appropriate custody, supporting compliance with regulatory requirements and secure information preservation.
Data Analysis and Statistical Plan
We process, review, and analyze the data obtained during the study following the previously approved statistical analysis plan. This activity allows us to generate consistent and verifiable results, facilitating the drawing of solid, reliable scientific conclusions fully aligned with the project’s objectives and methodological criteria.
Do you have any questions?
Send us your message and we’ll get back to you as soon as possible.