Posts Category: General

Risk identification in clinical trials is a proactive and ongoing process of systematically detecting, documenting, and assessing potential threats that could hinder the progress, integrity, or outcomes of a trial, setting the foundation for subsequent risk management activities. For clinical trial managers and clinical quality assurance managers, risk management is not just an optional add-on […]

This blog post explores the meaning of data integrity governed by the stringent ALCOA++ principles, and how this is maintained through robust vendor oversight practices and achieves regulatory compliance. From the initial vendor qualification process to data collection, processing, and reporting, each step is dissected to provide a clear understanding of the importance of setting […]

Understanding all the requirement of clinical trials necessitates a strong knowledge of the Good Clinical Practice (GCP) principles as laid out in the International Council for Harmonisation’s (ICH) E6 guidelines. These principles are the bedrock of ethical and efficient clinical trial management. When it comes to vendor management, aligning specific GCP sections with corresponding vendor […]

Good Clinical Practice (GCP) non-compliance in vendor management is an area that requires strict attention from sponsors and trial managers. This blog post will guide you through: The GCP guidelines are upheld in law and by regulatory bodies such as: Non-compliance with GCP can occur in various aspects of vendor management, ranging from inadequate record […]

Clinical Trial Vendor Management presents challenges that are complex, at the core of this, data emerges, offering clarity and direction. As we continue into the final segment of our Fire Triangle blog post series, it’s time to dive into the role data plays in robust vendor management strategies. Every decision, strategy and every outcome hinges […]

In Clinical Trial Vendor Management, communication is the oxygen, facilitating every process and enabling a seamless flow of data. Diving into the Fire Triangle’s second pillar, let’s explore the importance of effective Communication, focusing on its three primary components: Escalation, Expectations, and change management. Escalation Escalation management acts is a safety net within the clinical […]

The intricacies of Clinical Trial Vendor Management are woven into a series of processes, these processes are managed and delivered by different people within the organisation and are often performed simultaneously in multi-disciplinary teams, so how do we ensure consistency and quality in delivery of the process? Errors in conduct of these processes throughout the […]

Managing vendors in clinical trials is a fine balance of several critical elements. For many in the industry, understanding these elements’ significance and interplay can be complex. That’s where the analogy of the Fire Triangle comes in handy. Just as fire needs oxygen, heat, and fuel to ignite, robust vendor management in clinical trials depends […]

Clinical trials, come with their own unique set of regulatory challenges. This is a technical challenge when navigating vendor management and oversight. As with many challenges with moving parts, the devil is often in the details. In this blog post we’ll hit on four of these challenges and offer insight into how clinical quality, clinical […]

Welcome back to the concluding part of our three-part series, “Risk Management Frameworks for Vendor Risk Management.” In [Part 1] we introduced you to fundamental risk management methodologies like flowcharts, check sheets, process mapping, cause and effect diagrams, and Failure Mode Effects Analysis (FMEA). [Part 2] delved into more advanced techniques such as Failure Mode, […]