Tag: issue management

Governance Forums to Review and Decide on Critical Issues Understanding Governance Forums in Clinical Trials The governance structure of clinical trials is essential for ensuring adherence to regulatory requirements and maintaining trial integrity. Governance forums offer a collaborative framework for clinical operations, regulatory affairs, and medical affairs professionals to assess and address critical issues arising…

Read More “Governance Forums to Review and Decide on Critical Issues” »

Designing Escalation Paths for Site, Data and Vendor Issues Designing Escalation Paths for Site, Data and Vendor Issues In the highly regulated field of clinical trials, effective issue management is paramount. Within clinical research organization companies, the process of identifying, escalating, and resolving issues is critical to ensuring trial integrity and compliance. This comprehensive guide…

Read More “Designing Escalation Paths for Site, Data and Vendor Issues” »

Integrated Issue Management Across CTMS, eTMF and Quality Systems Integrated Issue Management Across CTMS, eTMF and Quality Systems Integrated issue management is critical for the success of clinical trials, particularly in the evolving landscape of biosimilar clinical trials, til therapy clinical trials, and others like the donanemab clinical trial or Sanofi clinical trials. This tutorial…

Read More “Integrated Issue Management Across CTMS, eTMF and Quality Systems” »

Issue Management in RBM: From Signal to Actionable Resolution Risk-Based Monitoring (RBM) in clinical trials offers considerable advantages in ensuring the safety and efficacy of treatments while optimizing resource use. Effective issue management is crucial within this framework, necessitating a structured approach that allows clinical operations, regulatory affairs, and medical affairs professionals to identify, evaluate,…

Read More “Issue Management in RBM: From Signal to Actionable Resolution” »