To improve quality and efficiency, sponsors and CROs should provide visit guidance, integrated calculators, continuous trial-specific training, and centralized resources for site staff. These strategies help reduce protocol deviations, enhance compliance, and streamline trial operations, ultimately minimizing risks and improving overall trial outcomes.
Given that sites are already occupied with non-trial clinical patient care, maintaining awareness of regulatory and activation requirements becomes a formidable task. This eBook delves into site and protocol violations, offering insights on how to assist sites enhance their compliance without adding undue burdens.
This comprehensive step-by-step guide is designed to assist sponsors and clinical trial sites in effectively preparing for and navigating the different types of audits. From pre-trial readiness to post-trial reviews, the guide outlines key considerations, best practices, and actionable strategies to ensure compliance.
Technology and proactive oversight can significantly contribute to successful trial implementation and mitigate risks at the site level. Learn how research teams can better promote the smooth running of clinical trials and clear the way for medical advancements.
Advarra’s experts can work directly with your team to provide global consulting and evaluation services related to research, clinical quality assurance, regulatory compliance, and human research protection.
