Posts by Author: Tom Lazenby

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 […]

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 […]

Marked by increasing intricacies and soaring costs, clinical trials are always changing. In this landscape, the selection and management of vendor services stand out as a key element in enhancing operational efficiency and controlling expenditures. This blog post is intended to unpack the financial implications of vendor contributions in clinical trials, highlighting the potential of […]

The evolution of clinical trials, characterised by increasingly complex trial designs and regulatory frameworks, requires a strategic approach to digital integration. As digital tools become more prevalent it is important for organisations to adopt technologies thoughtfully to enhance efficiency and remain competitive. Maximising Value through Strategic Investments A critical first step in digital integration is […]

A Surgical Approach to Efficiency and Compliance The objective when delivering a clinical trial is to not only reach the goal but to complete with surgical precision. Risk-Based Quality Management (RBQM) is an instrumental framework, often not considered in the processes of clinical trial vendor management. Adopting RBQM enables a broad-stroke strategy to a tailored […]