Efficient regulatory management and structured study start-up are critical to achieving first-subject-in on time and ensuring full compliance throughout clinical development. CRS provides comprehensive regulatory and start-up support for early-phase and clinical development programs across the EU.

Our team manages the full regulatory pathway, from initial strategy through approvals and site activation. We support sponsors in preparing and submitting regulatory dossiers in accordance with applicable EU regulations, national requirements, and ethics committee expectations. This includes coordination of Clinical Trial Applications (CTA), ethics submissions, amendments, and regulatory correspondence throughout the study lifecycle.CRS provides hands-on support for the preparation, review, and quality control of essential documents, including study protocols, investigator brochures, informed consent forms, patient information sheets, and safety documentation.

All documents are reviewed to ensure regulatory compliance, consistency, and readiness for submission.During study start-up, we coordinate all operational activities required to activate sites efficiently. This includes site feasibility support, contract and budget coordination, investigator documentation collection, and readiness checks prior to study initiation. We work closely with sponsors, investigators, and third-party vendors to ensure alignment across all stakeholders.For early-phase and first-in-human studies,

CRS places particular emphasis on safety, risk mitigation, and regulatory readiness. We support dose escalation governance, safety committee coordination, and rapid implementation of protocol amendments when required.Our regulatory and start-up services are fully integrated with project management and clinical operations, enabling clear timelines, transparent communication, and proactive issue resolution. This integrated approach reduces delays, minimizes regulatory risk, and supports predictable study execution.CRS acts as a reliable regulatory partner, ensuring that clinical trials are initiated efficiently, compliantly, and with a strong foundation for successful execution.

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