Effective vendor management through robust auditing strategies is imperative for success. In this blog post I have thought about the critical components and strategic requirements of risk-based and value-based audit strategies. These strategies are crucial for enhancing the efficiency, reliability, and outcome of clinical trials. Understanding how prioritising audit resources, aligning with broader business goals,…

Welcome back to the Mayet blog! As proud sponsors of this year’s Institute of Clinical Research Ethics and GCP Forum, we had the unique opportunity to engage directly incredible community at the forefront of clinical trials. A special thanks to the Institute for hosting us, to UCL for providing a fantastic venue, and to the…

The success of a clinical trial significantly depends on the careful selection and management of external vendors. Vendor qualification is critical to an outsourcing strategy, ensuring that every entity involved in a trial meets the standards required for a successful outcome. This blog post explores the role of vendor qualification in clinical trials, including its…

My perspective and ideas below are informed by my analysis of the EMA GCP Inspection Working Group Report 2022, which underscores the critical role of well-defined contractual agreements in the overarching framework of clinical trial management. The life cycle of a clinical trial is defined by the Protocol and what is required to be delivered,…

Choosing the right vendor is crucial for the success of clinical trials. This blog post serves as a practical guide for Clinical QA professionals, Outsourcing Leads, and Operating Managers embarking on the vendor assessment journey. I’ll cover the complex process of evaluating vendors, covering key areas such as their capabilities, delivery track record, compliance with…

Elevating Our Security Commitment: Mayet Achieves Cyber Essentials Plus Certification We’re proud to announce another significant stride in our ongoing journey towards unparalleled security and compliance: Mayet has been awarded the Cyber Essentials Plus certificate. This achievement not only elevates our security posture but also reaffirms our unwavering commitment to safeguarding the data that fuels…

The integration of digital solutions is critical for organisation success and efficiency, particularly with the growing number and variety of systems available. The prospect of onboarding new vendors and ensuring seamless, robust and compliant software integrations can often seem daunting to pharmaceutical companies. The fear of non-compliance with Good Clinical Practice (GxP) regulations, coupled with…

A Systematic Redirection Towards Proactive Management Integrating risk-based quality management, and identifying and managing critical to quality factors has become a core activity of successful trial delivery. If you’re part of a clinical trial team or a clinical trial Sponsor organisation, you’re likely aware of the challenges and problems that accompany the requirements of vendor…

Setting the Scene In the rapidly evolving landscape of computerised systems within regulated environments, the importance of rigorous Quality Assurance (QA) testing of GxP computerised systems cannot be overstated. As we navigate through the intricacies of Computer System Validation (CSV) and the emerging focus on Computer System Assurance (CSA), it’s crucial to understand the fundamental…

Accessibility is not a popular topic in technology, but it’s one of the most important if you want to ensure everyone can use your web app. Our goal with our first accessibility review and improvements was to fix the obvious issues (that are sometimes not that obvious) so that our app is, at the very…