Cyntegrity reposted this
With the upcoming ICH E6(R3) guidelines, the role of #MedicalMonitors in clinical trials is expanding, introducing new responsibilities that bring fresh challenges. This article highlights key changes in medical monitoring and explores ways to address these demands effectively. Medical monitors are central to trial safety, data accuracy, and compliance with regulatory standards. Under E6(R3), their responsibilities deepen in critical areas: 🔹 Expanded Safety Oversight: Medical monitors now have heightened roles in risk management, emphasizing consistent, centralized, and remote safety monitoring. 🔹 Strengthened Data Quality and Security: New standards call for stringent data handling practices, requiring medical monitors to ensure accuracy, confidentiality, and adherence to compliance guidelines. 🔹 Optimized Workflows: Balancing these requirements means monitors must access, review, and interpret multi-source data more efficiently to support fast, informed decision-making. This article explores practical approaches and advanced technologies to support these evolving demands, offering ways to simplify data management, enable real-time risk detection, and provide unified access to critical participant information: https://lnkd.in/dEZhZbWz #ClinicalTrials #Pharmacovigilance #ClinicalResearch #ICHGuidelines #ClinicalData #DrugSafety #PatientProfiles #CRO #Biotech #Pharma
