Offer a rich network of qualified research sites meeting the specific needs of the trials for our sponsors. We offer a complete solution of site management, including contracting and budgeting with clinical investigators and IRB approvals.
Develop and implement effective patient recruitment strategies involving collaborating with patient advocacy groups, utilizing online platforms, and conducting targeted advertising campaigns. We also manage the informed consent process, ensuring that potential participants fully understand the risks and benefits of participating in the study. Also, provide ongoing support to participants, address their concerns, and maintain clear communication channels thus ensuring patient retention and minimizing patient drop out rates.
Ensure research sites adhere to the protocol’s data collection procedures by implementing electronic data capture (EDC) systems to streamline data entry, minimize errors, and facilitate real-time data monitoring. Establish quality control procedures to ensure data completeness and consistency across all participating sites. Facilitate communication between the research site and the sponsor to address any data queries or discrepancies that may arise.
Maintain comprehensive regulatory documentation, including informed consent forms, investigator brochures, and regulatory binders. We also manage communication with regulatory agencies, address any questions/ concerns, and prepare and submit required reports.
Assist with site initiation visits, involving training research staff on the study protocol and data collection procedures. Regularly conduct ongoing site monitoring visits to ensure continued adherence to the protocol and data quality standards.
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