Mayet Blog

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…

Part 2: Resource Optimisation Welcome back to our series on the strategic impact of vendor management and oversight in clinical trials. In part one, we discussed the importance of risk management. In this article, we explore how resource optimisation in vendor management and oversight impacts: Below is a list of some common methods that businesses…

Part 1 – Risk Management Clinical trial sponsors face numerous challenges in managing vendors and ensuring the success of their trials. Clinical trial sponsors must take a strategic approach to vendor management. This involves aligning vendor management with business strategy to ensure that vendors are selected, managed, and evaluated in a way that supports the…

Effective vendor management and oversight are critical to the success of a clinical trial. It’s not just about choosing the right vendors but also about efficiently managing and overseeing them throughout the trial. By integrating these key processes into your QMS, you’re creating a comprehensive system that aids in reducing risks, improving quality, and facilitating…

Clinical Trials are complex and even more so when multiple key deliverables are outsourced by Sponsors. It is critical for Sponsors to ensure regulatory compliance and patient safety and data integrity. The cost of non-compliance can be significant and anxiety-inducing to the most diligent clinical research professionals. Regulatory inspection findings can lead to increased scrutiny,…

The FDA guidance on quality risk management released in May (2023) offers principles and examples applicable to various pharmaceutical quality aspects. The principles of quality risk management in this guidance can be extended to clinical trial vendor risk management, covering different stages of a clinical trial. When applied to clinical trial vendor risk management, the…