At HSI CRO (Contract Research Organization), we provide comprehensive, integrated services that support your scientific research and clinical studies from concept to completion. Our service model ensures continuity, regulatory compliance, and operational excellence at every stage of development.
Regulatory compliance is at the core of every successful clinical trial. Our Regulatory Affairs team provides strategic guidance and hands-on support to navigate complex local and international requirements efficiently.
We handle all aspects of regulatory planning, dossier preparation, and submissions to national competent authorities and ethics committees. From authoring the initial protocol and Investigator’s Brochure to managing Clinical Trial Applications (CTAs), we ensure all documentation is accurate, GCP-compliant, and submitted in a timely manner.
Our team also supports:
We monitor changing regulations to ensure your study remains compliant throughout its lifecycle.
We know that time is critical. Our study start-up team accelerates site activation by combining deep local knowledge with efficient coordination. From feasibility through site initiation, we manage every step to reduce delays and ensure readiness.
Our services include:
Clinical operations is the backbone of trial execution. Our experienced Clinical Research Associates (CRAs) and Project Managers ensure your study is conducted according to protocol, on time, and within budget.
We offer full-service clinical monitoring, including both onsite and remote visits, risk-based monitoring, and issue resolution. Our clinical team works closely with sites to support enrollment, ensure protocol adherence, and maintain high-quality data collection.
Based on our international experience, we guarantee that your research will be conducted in accordance with the highest GCP and ISO standards.
