Blog
Insights on clinical QA, vendor oversight, and the technology shaping pharma and biotech.
Articles
5 Common Pitfalls in Risk Identification and How to Avoid Them
Five mistakes that undermine risk identification in clinical trial vendor management, from subjective bias to overlooking emerging threats.
Tom Lazenby Vendor Oversight and Data Integrity
How ALCOA++ principles govern data integrity in clinical trials, and why robust vendor oversight is essential to maintaining it throughout the trial lifecycle.
Tom Lazenby GCP Principles and Vendor Management
Mapping ICH E6 GCP principles to specific vendor management activities, from quality systems and CRO oversight to data handling and audit requirements.
Tom Lazenby GCP Non-Compliance in Vendor Management
What GCP non-compliance in vendor management looks like, its regulatory implications, and how sponsors can mitigate these risks effectively.
Tom Lazenby The Fire Triangle: Part 3 – Data Applications in Vendor Management
Part 3 of the Fire Triangle series on how data, KPIs, and real-time analytics transform vendor management from reactive guesswork to predictive oversight.
Tom Lazenby The Fire Triangle: Part 2 Expert Communication
Part 2 of the Fire Triangle series exploring communication as the oxygen of vendor management — covering escalation, expectations, and change management.
Tom Lazenby Fire Triangle: Part 1 Process Playbook
Part 1 of the Fire Triangle series covering the eight core vendor management processes, from selection and qualification to performance management and closeout.
Tom Lazenby Introduction to the Fire Triangle of Clinical Trial Vendor Management
Introducing the Fire Triangle of clinical trial vendor management — the three elements every sponsor needs: communication, processes, and data.
Tom Lazenby 4 Common Regulatory Challenges in Clinical Trials Vendor Management and Oversight
Four regulatory challenges sponsors face in clinical trial vendor management, from keeping up with multi-region requirements to demonstrating adequate oversight.
Tom Lazenby Risk Management Frameworks for Vendor Risk Management - Part 3
Part 3 of the risk management frameworks series covering HAZOP, Preliminary Hazard Analysis, and Risk Ranking and Filtering for vendor management.
Tom Lazenby Tools and Frameworks for Vendor Risk Management - Part 2
Part 2 of the risk management series covering advanced techniques: FMECA, Fault Tree Analysis, and Hazard Analysis and Critical Control Points.
Tom Lazenby Tools and Frameworks for Vendor Risk Management - Part 1
Part 1 of a three-part series introducing fundamental risk management tools for vendor oversight: flowcharts, check sheets, process mapping, and FMEA.
Tom Lazenby 5 Pitfalls in Transfer of Regulatory Responsibilities in Clinical Trials and How to Avoid Them
Five common pitfalls when delegating regulatory responsibilities to vendors, including inadequate quality agreements and unclear accountability.
Tom Lazenby Preparation to Closeout: How to Optimise Sponsor Oversight in Clinical Trial Vendor Management
How to optimise sponsor oversight across the full vendor management lifecycle, from preparation and subcontractor management through to study closeout.
Tom Lazenby Reactive to Proactive: A new approach to Clinical Trial Vendor Management and Oversight
Why clinical trial vendor management must shift from reactive firefighting to proactive oversight, and how to make that transition practically.
Tom Lazenby Strategic Impact of Communication in Vendor Management and Oversight
Part 3 of the strategic impact series exploring how structured communication practices drive vendor performance and support clinical trial objectives.
Tom Lazenby Announcement: Mayet Acquires New Advisor
Jo Burmester, clinical research training consultant with over 30 years of industry experience, joins Mayet as an Advisor.
Tom Lazenby Strategic Impact of Vendor Management and Oversight
Part 2 of the strategic impact series on resource optimisation in vendor management — from automating tasks to risk-based allocation of oversight effort.
Tom Lazenby Aligning Vendor Management with Strategic goals for Clinical Trial Sponsors
How aligning vendor risk management with business strategy helps sponsors reduce time to market, cut costs, and decrease inspection findings.
Tom Lazenby Key Processes in Vendor Management and Oversight: A Deep Dive into Effective QMS
A deep dive into integrating vendor management processes into your Quality Management System, from selection and qualification to performance monitoring.
Tom Lazenby