Site & Investigator Management
We manage communication with ophthalmology sites and research teams to ensure smooth study execution. We make sure each site is properly prepared, trained, and aligned with the specific requirements of the clinical trial, maximizing both study quality and effectiveness.
SITE INITIATION VISITS (SIV)
We verify that each center is fully prepared to start the study. We review the suitability of equipment, available infrastructure, and the correct implementation of procedures and the protocol. In addition, we provide the necessary training to the staff, ensuring a consistent and trouble-free startup.
Research Team Training
We train research teams on the protocol and applicable Good Clinical Practices (GCP), ensuring they fully understand trial procedures and requirements. This training ensures consistent execution in line with quality standards and project objectives.
MANAGEMENT AND MAINTENANCE OF THE INVESTIGATOR SITE FILE (ISF)
We organize and maintain the Investigator Site File in an up-to-date state, ensuring that all relevant documentation is complete, accessible, and compliant with applicable regulations. We continuously monitor its status to maintain traceability and compliance throughout the study.
Updating Site Regulatory Documentation
We periodically review and update each site’s regulatory documentation, ensuring it complies with current legal requirements and the specific demands of the study. This maintains documentary consistency and minimizes the risk of regulatory deviations.
ONGOING COMMUNICATION WITH THE PRINCIPAL INVESTIGATOR
We maintain constant communication with the Principal Investigator, coordinating operational and clinical aspects to ensure the proper conduct of the study. This interaction helps prevent issues, facilitates decision-making, and ensures that the trial is conducted efficiently and in accordance with the protocol.
PATIENT RECRUITMENT AND RETENTION SUPPORT
We provide support in patient recruitment and their follow-up throughout the study, helping to maintain their participation until completion and promoting the continuity of the process according to the established criteria.
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