Just ask us about our new client packages!
Just ask us about our new client packages!
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Our Regulatory Maintenance service is tailored to ensure your clinical research stays compliant from start to finish. We specialize in managing and maintaining all regulatory documents and files, ensuring they are current and in full alignment with evolving standards. Additionally, we handle sponsor and CRO affairs, including coordinating meetings and overseeing monitoring visits, so you can focus on advancing your research while we manage the compliance and administrative details.
Our Research Auditing service delivers a rigorous and detailed evaluation of your clinical studies to ensure adherence to ICH GCP and regulatory standards. We perform comprehensive audits of your site processes, documentation, and data, identifying areas for improvement and ensuring compliance. Our expert team provides detailed reports with actionable insights, preparing you thoroughly for FDA or sponsor audits. As your dedicated partner, we are committed to enhancing the quality and integrity of your research site.
Our Clinical Research Consulting service provides expert guidance to streamline your clinical trials and achieve optimal outcomes. We offer strategic advice on study design, regulatory compliance, and operational management. Our team supports research sites throughout the entire site start-up process, providing resources to effectively obtain studies. We also assist in achieving compliance with HIPAA, FDA, and OSHA regulations, ensuring that all aspects of your research operations meet the highest standards. With our comprehensive support, you can navigate challenges, enhance efficiency, and ensure a successful and compliant research journey.
Modeli Research Consultants
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