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64 articles in this category
Articles
From Spreadsheet Prison to Second Brain: The Upgrade That Pays for Itself
“Why clinical operations teams stay stuck in fragile spreadsheet systems, and how to break the cycle of adoption resistance and manual workarounds.”
Tom Lazenby The Quiet Exhaustion of Clinical Project Managers
Clinical project management stalls not because people stop caring, but because fragmented systems and endless documentation consume all the energy.
Tom Lazenby Digital Oversight Is Here: Manual Systems Are the New Compliance Risk
Why spreadsheet-based tracking has become a compliance risk, and how manual systems fail to support RBQM or modern study accountability.
Tom Lazenby Why Validation Documentation Alone Isn't Enough (And What Actually Is)
Why validation documentation alone isn't enough for clinical trial software implementations, and what comprehensive vendor support should actually include.
Tom Lazenby 99 Problems in Vendor Management
99 real vendor management frustrations collected from hundreds of conversations with clinical trial professionals. If these sound familiar, we can help.
Tom Lazenby Mayet Goes Modular!
Mayet launches a modular pricing model so clinical trial sponsors can choose only the vendor management capabilities they need and pay accordingly.
Tom Lazenby Integration Partnership with PHARMASEAL CTMS
Mayet announces its first integration partnership with PHARMASEAL CTMS, connecting vendor management and clinical trial management in one platform.
Tom Lazenby Mayet Strengthens Quality Leadership with Addition of New Strategic Advisor
Rosemarie Corrigan, former EVP of Global Quality at Worldwide Clinical Trials, joins Mayet as Strategic Advisor.
Tom Lazenby 8 Transformative ICH E6(R3) Service Provider Management Requirements
Eight critical service provider management requirements under ICH E6(R3) and how to implement them for compliant clinical trial delivery.
Tom Lazenby The Human Side of Clinical Trial Quality
Why people — not just processes and technology — remain the most important driver of clinical trial quality, and how to keep the human element central.
Tom Lazenby Mayet Strengthens Commercial Leadership with Addition New Strategic Advisor
Dr. Andrew Copestake, with over three decades of executive leadership in pharma, biotech, and CRO sectors, joins Mayet as Strategic Advisor.
Tom Lazenby Vendor Risk Management: A Modern Approach
How the shift from 'CRO' to 'service provider' in ICH E6(R3) demands a fundamentally new approach to vendor risk management across eight critical areas.
Tom Lazenby Key Trends Shaping Clinical Trial Quality in 2025
Key trends reshaping clinical trial quality in 2025, from AI validation challenges to ICH E6(R3) compliance and the growing complexity of vendor networks.
Tom Lazenby Modernising Service Provider Management: Your Current Approach May Be Obsolete
Why traditional vendor management approaches are becoming obsolete, and what the shift to ICH E6(R3) service provider terminology means for sponsors.
Tom Lazenby Breaking Down FDA Finalised Guidance for DCTs
Breaking down the FDA's 2024 finalised guidance on decentralized clinical trials, covering risk management, vendor oversight, and data integrity requirements.
Tom Lazenby When Does Oversight Become Overkill?
Finding the balance between thorough vendor oversight and operational efficiency — when does compliance-driven monitoring start hurting ROI?
Tom Lazenby The Rise of Decentralized Clinical Trials
A comprehensive guide to decentralized clinical trials covering their evolution, advantages, patient centricity, regulatory considerations, and vendor oversight challenges.
Tom Lazenby Exploring the Non-Linear Relationship Between Risk and Complexity in Clinical Trials
Exploring why more complex clinical trials don't always mean more risk, and how sponsors should calibrate oversight under ICH E6(R3).
Tom Lazenby Total Cost Of Risk in Clinical Trial Outsourcing
Applying the Total Cost of Risk framework from insurance to clinical trial outsourcing — finding the sweet spot between risk investment and risk exposure.
Tom Lazenby Evolution of Outsourcing in Clinical Trials
How clinical trial outsourcing has evolved from spot contracting to strategic partnerships, and why the model needs to change again.
Tom Lazenby Cooking Up Success: The Chef’s Guide to Clinical Vendor Management
An analogy comparing clinical trial vendor management to running a kitchen — from grocery shopping (vendor selection) to plating the perfect meal (trial delivery).
Tom Lazenby Avoiding TMF Transfer Disasters: A Sponsor's Survival Guide
How to avoid Trial Master File transfer disasters when retrieving documentation from CROs, covering data integrity, security, and format risks.
Tom Lazenby What's In A Name?
The story behind our company name and what Mayet represents for clinical trial quality and vendor oversight.
Tom Lazenby Managing Underperforming Vendors
Practical strategies for managing vendors who looked great on paper but fail to deliver, from early warning signs to structured recovery plans.
Tom Lazenby Vendor Audit Strategy: Perfecting the Process for Peak Performance
How to build risk-based and value-based audit strategies that focus resources where they matter most for clinical trial vendor performance.
Tom Lazenby Vendor Horror Stories - Conference Recap
Real vendor management horror stories collected at the ICR Ethics and GCP Forum, analysed for root causes and lessons learned.
Tom Lazenby Vendor Qualification: The Key to Ensuring Clinical Trial Success
Why vendor qualification is critical to clinical trial success, covering capability assessment, compliance verification, and ongoing performance evaluation.
Tom Lazenby Crafting Compliance in Trial Contracts
How well-crafted contracts form the strategic foundation of clinical trial delivery, informed by EMA GCP Inspection Working Group findings.
Tom Lazenby Best Practices: Clinical Trial Vendor Selection and Qualification
A practical guide to clinical trial vendor selection covering capability assessment, due diligence, financial evaluation, and contract negotiation.
Tom Lazenby Securing Success: Achieving Cyber Essentials Plus
Mayet achieves Cyber Essentials Plus certification, demonstrating advanced cybersecurity practices verified through independent technical audit.
Neyts Zupan Vendor Onboarding: Best Practices for Digital Integration
Best practices for onboarding new software vendors in clinical trials, including API integration strategies and GxP compliance considerations.
Tom Lazenby Critical to Quality Factors and Vendor Oversight
How identifying and managing critical-to-quality factors enables proactive vendor oversight and improves clinical trial delivery outcomes.
Tom Lazenby GxP Validation: Mayet's Path to Excellence in QA Testing
How Mayet approaches QA testing of GxP computerised systems, bridging traditional CSV and modern Computer System Assurance methodologies.
Neyts Zupan 80/20 of web accessibility for web apps
A practical guide to fixing the most impactful web accessibility issues in your app, covering contrast, navigation, screen readers, and dark mode.
Dejan Murko Enhancing Clinical Trial Partnerships through Effective Financial Analysis
How to evaluate the financial impact of vendor services in clinical trials through structured cost-benefit analysis and strategic partnership planning.
Tom Lazenby A Practical Guide: Strategic Digital Integration in Clinical Operations
A practical guide to strategic digital integration in clinical operations, from ROI assessment to implementation and change management.
Tom Lazenby RBQM: Surgical Precision in Vendor Management
How Risk-Based Quality Management brings surgical precision to clinical trial vendor oversight, replacing broad-stroke approaches with targeted risk control.
Tom Lazenby A New Milestone in Security Excellence: Mayet Earns the Cyber Essentials Certification
Mayet passes an independent security audit and earns the Cyber Essentials certification, reinforcing our commitment to data protection in clinical research.
Neyts Zupan Mayet is proud to welcome a new Advisor and team member into the fold
Chris Shepherd, former VP and Head of R&D Quality at GSK and RQA Honorary Life Fellow, joins Mayet as an Advisor.
Tom Lazenby The Sponsor’s Guide: Record Keeping for Vendor Oversight Compliance
Why centralised record-keeping is essential for vendor oversight compliance, and how poor documentation leads to inspection findings and trial delays.
Tom Lazenby 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 Best Practices for Maintaining Regulatory Compliance in Vendor Management and Oversight
Best practices for maintaining regulatory compliance in vendor management, including the real costs of inspection findings and how to prevent them.
Tom Lazenby Applying Principles of FDA Guidance for Industry Q9 Quality Risk Management 2023 to Vendor Risk Management
Applying the FDA's 2023 Q9 quality risk management guidance to clinical trial vendor oversight, from vendor selection through post-trial activities.
Tom Lazenby Vendor Level vs Study Level Vendor Risk Assessment: A Robust Approach
Understanding the difference between vendor-level and study-level risk assessments, and why both are essential for effective clinical trial oversight.
Tom Lazenby Welcome to Mayet: Spearheading change in Clinical Research Vendor Management
Introducing Mayet — an all-in-one vendor management platform built to streamline clinical trial outsourcing oversight for pharma and biotech sponsors.
Tom Lazenby