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,…

Welcome to Part 2 of our three-part blog series, “Tools and Frameworks for Vendor Risk Management.” [Part 1] explored fundamental risk management methodologies, including flowcharts, check sheets, process mapping, cause and effect diagrams, and Failure Mode Effects Analysis (FMEA). In Part 2, you will learn about some more advanced risk management techniques, introducing: We will…

This is a three-part blog series, “Tools and Frameworks for Vendor Risk Management,” where you will learn or be reacquainted with various risk management methodologies that can be employed to manage and mitigate risks associated with vendors in clinical trials. The series is designed to help you understand What, Why, When, and How these methodologies…

Robust oversight of the delegated regulatory responsibilities in clinical trials is a challenge. Sponsors are outsourcing more of their clinical operations to vendors, the dynamics of responsibility and oversight becomes complex. When outsourced responsibilities are not managed properly, this process leads to a range of issues, from quality concerns and inspection findings to significant delays…

Sponsor oversight of vendor management is a critical aspect that requires attention, especially when dealing with subcontractors. For clinical trial Sponsor organisations, managing subcontractors used by the primary vendor can be complex and filled with challenges. This blog post aims to shed light on how to optimise this process from preparation to closeout. The Importance…

Faced with increased development costs, delays in studies, and a decrease in the quality of clinical trial outputs, the industry is experiencing an urgent call to transition from a reactive to a proactive mentality – this can also be achieved in vendor management and oversight. For instance, a study by the Tufts Center for the…

Part 3 – Communication This is the third instalment of our blog series on the strategic impact of vendor management and oversight in clinical trials. In this instalment, we will delve into the crucial role of communication in vendor management and oversight to achieve the strategic objectives clinical trial Sponsors. Clear and efficient communication practices…

Our New Team Member We’re excited to announce that Jo Burmester is joining our ranks as an Advisor. This collaboration is a critical step forward in our journey to elevate the clinical trials sector, bringing us unmatched support, knowledge, and guidance. Jo Burmester is an accomplished Clinical Research Training Consultant, boasting over three decades of…