Posts by Author: Tom Lazenby

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 […]

Chris Shepherd on joining Mayet as an Advisor: “I am very excited to have been approached by Mayet to join as an advisor. Mayet has recognised a market need for an integrated software tool tailored to the biopharma industry. This tool will consolidate quality and performance KPIs, audits, risks, and various issues from multiple therapy […]

Vendor management and meticulous record-keeping are paramount for Sponsors, as they navigate through the web of regulatory compliance and ensure the seamless conduct of trials. Importance of Record Keeping in Vendor Management Clinical Trial Sponsors, tasked responsibility of overseeing successful, efficient and compliant clinical trials, need to implement a meticulous and centralised record-keeping system throughout […]

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 […]