Blog
Insights on clinical QA, vendor oversight, and the technology shaping pharma and biotech.
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