Insights on clinical QA, vendor oversight, and the technology shaping pharma and biotech.http://localhost:4321/http://localhost:4321/blog/new-clinical-project-management/http://localhost:4321/blog/new-clinical-project-management/“Why clinical operations teams stay stuck in fragile spreadsheet systems, and how to break the cycle of adoption resistance and manual workarounds.”Wed, 26 Nov 2025 00:00:00 GMTGeneralTom Lazenbyhttp://localhost:4321/blog/clinical-project-manager-pain/http://localhost:4321/blog/clinical-project-manager-pain/Clinical project management stalls not because people stop caring, but because fragmented systems and endless documentation consume all the energy.Wed, 19 Nov 2025 00:00:00 GMTGeneralTom Lazenbyhttp://localhost:4321/blog/clinical-trial-systems-compliance/http://localhost:4321/blog/clinical-trial-systems-compliance/Why spreadsheet-based tracking has become a compliance risk, and how manual systems fail to support RBQM or modern study accountability.Wed, 12 Nov 2025 00:00:00 GMTGeneralTom Lazenbyhttp://localhost:4321/blog/more-than-validation-docs/http://localhost:4321/blog/more-than-validation-docs/Why validation documentation alone isn't enough for clinical trial software implementations, and what comprehensive vendor support should actually include.Mon, 13 Oct 2025 00:00:00 GMTGeneralTom Lazenbyhttp://localhost:4321/blog/99-problems/http://localhost:4321/blog/99-problems/99 real vendor management frustrations collected from hundreds of conversations with clinical trial professionals. If these sound familiar, we can help.Wed, 04 Jun 2025 00:00:00 GMTGeneralTom Lazenbyhttp://localhost:4321/blog/mayet-goes-modular/http://localhost:4321/blog/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.Wed, 16 Apr 2025 00:00:00 GMTGeneralTom Lazenbyhttp://localhost:4321/blog/integration-partnership-ps/http://localhost:4321/blog/integration-partnership-ps/Mayet announces its first integration partnership with PHARMASEAL CTMS, connecting vendor management and clinical trial management in one platform.Wed, 09 Apr 2025 00:00:00 GMTGeneralTom Lazenbyhttp://localhost:4321/blog/new-advisor-rosemarie/http://localhost:4321/blog/new-advisor-rosemarie/Rosemarie Corrigan, former EVP of Global Quality at Worldwide Clinical Trials, joins Mayet as Strategic Advisor.Tue, 01 Apr 2025 00:00:00 GMTGeneralTom Lazenbyhttp://localhost:4321/blog/8-gcp-provider-management-requirements/http://localhost:4321/blog/8-gcp-provider-management-requirements/Eight critical service provider management requirements under ICH E6(R3) and how to implement them for compliant clinical trial delivery.Wed, 12 Mar 2025 00:00:00 GMTGeneralTom Lazenbyhttp://localhost:4321/blog/human-side-of-quality/http://localhost:4321/blog/human-side-of-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.Wed, 29 Jan 2025 00:00:00 GMTGeneralTom Lazenbyhttp://localhost:4321/blog/new-advisor-drcopestake/http://localhost:4321/blog/new-advisor-drcopestake/Dr. Andrew Copestake, with over three decades of executive leadership in pharma, biotech, and CRO sectors, joins Mayet as Strategic Advisor.Wed, 22 Jan 2025 00:00:00 GMTGeneralTom Lazenbyhttp://localhost:4321/blog/risk-a-modern-approach/http://localhost:4321/blog/risk-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.Wed, 15 Jan 2025 00:00:00 GMTGeneralTom Lazenbyhttp://localhost:4321/blog/trial-quality-trends-2025/http://localhost:4321/blog/trial-quality-trends-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.Thu, 02 Jan 2025 00:00:00 GMTGeneralTom Lazenbyhttp://localhost:4321/blog/modernising-service-provider-management/http://localhost:4321/blog/modernising-service-provider-management/Why traditional vendor management approaches are becoming obsolete, and what the shift to ICH E6(R3) service provider terminology means for sponsors.Tue, 17 Dec 2024 00:00:00 GMTGeneralTom Lazenbyhttp://localhost:4321/blog/fda-guidance-dcts/http://localhost:4321/blog/fda-guidance-dcts/Breaking down the FDA's 2024 finalised guidance on decentralized clinical trials, covering risk management, vendor oversight, and data integrity requirements.Mon, 23 Sep 2024 00:00:00 GMTGeneralTom Lazenbyhttp://localhost:4321/blog/when-does-oversight-become-overkill/http://localhost:4321/blog/when-does-oversight-become-overkill/Finding the balance between thorough vendor oversight and operational efficiency — when does compliance-driven monitoring start hurting ROI?Tue, 03 Sep 2024 00:00:00 GMTGeneralTom Lazenbyhttp://localhost:4321/blog/decentralized-clinical-trials/http://localhost:4321/blog/decentralized-clinical-trials/A comprehensive guide to decentralized clinical trials covering their evolution, advantages, patient centricity, regulatory considerations, and vendor oversight challenges.Tue, 20 Aug 2024 00:00:00 GMTGeneralTom Lazenbyhttp://localhost:4321/blog/non-linear-risk-and-complexity/http://localhost:4321/blog/non-linear-risk-and-complexity/Exploring why more complex clinical trials don't always mean more risk, and how sponsors should calibrate oversight under ICH E6(R3).Tue, 13 Aug 2024 00:00:00 GMTGeneralTom Lazenbyhttp://localhost:4321/blog/total-cost-of-risk-management/http://localhost:4321/blog/total-cost-of-risk-management/Applying the Total Cost of Risk framework from insurance to clinical trial outsourcing — finding the sweet spot between risk investment and risk exposure.Wed, 07 Aug 2024 00:00:00 GMTGeneralTom Lazenbyhttp://localhost:4321/blog/evolution-of-outsourcing-1/http://localhost:4321/blog/evolution-of-outsourcing-1/How clinical trial outsourcing has evolved from spot contracting to strategic partnerships, and why the model needs to change again.Thu, 25 Jul 2024 00:00:00 GMTGeneralTom Lazenbyhttp://localhost:4321/blog/chefs-guide-to-vendor-management/http://localhost:4321/blog/chefs-guide-to-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).Tue, 18 Jun 2024 00:00:00 GMTGeneralTom Lazenbyhttp://localhost:4321/blog/tmf-transfer-disasters/http://localhost:4321/blog/tmf-transfer-disasters/How to avoid Trial Master File transfer disasters when retrieving documentation from CROs, covering data integrity, security, and format risks.Wed, 05 Jun 2024 00:00:00 GMTGeneralTom Lazenbyhttp://localhost:4321/blog/whats-in-a-name/http://localhost:4321/blog/whats-in-a-name/The story behind our company name and what Mayet represents for clinical trial quality and vendor oversight.Fri, 24 May 2024 00:00:00 GMTGeneralTom Lazenbyhttp://localhost:4321/blog/underperforming-vendors/http://localhost:4321/blog/underperforming-vendors/Practical strategies for managing vendors who looked great on paper but fail to deliver, from early warning signs to structured recovery plans.Wed, 08 May 2024 00:00:00 GMTGeneralTom Lazenbyhttp://localhost:4321/blog/vendor-audit-strategy/http://localhost:4321/blog/vendor-audit-strategy/How to build risk-based and value-based audit strategies that focus resources where they matter most for clinical trial vendor performance.Wed, 01 May 2024 00:00:00 GMTGeneralTom Lazenbyhttp://localhost:4321/blog/vendor-horror-stories/http://localhost:4321/blog/vendor-horror-stories/Real vendor management horror stories collected at the ICR Ethics and GCP Forum, analysed for root causes and lessons learned.Wed, 24 Apr 2024 00:00:00 GMTGeneralTom Lazenbyhttp://localhost:4321/blog/vendor-qualification-trial-success/http://localhost:4321/blog/vendor-qualification-trial-success/Why vendor qualification is critical to clinical trial success, covering capability assessment, compliance verification, and ongoing performance evaluation.Wed, 17 Apr 2024 00:00:00 GMTGeneralTom Lazenbyhttp://localhost:4321/blog/compliance-in-contracts/http://localhost:4321/blog/compliance-in-contracts/How well-crafted contracts form the strategic foundation of clinical trial delivery, informed by EMA GCP Inspection Working Group findings.Wed, 10 Apr 2024 00:00:00 GMTGeneralTom Lazenbyhttp://localhost:4321/blog/best-practices-selection-and-qualification/http://localhost:4321/blog/best-practices-selection-and-qualification/A practical guide to clinical trial vendor selection covering capability assessment, due diligence, financial evaluation, and contract negotiation.Wed, 03 Apr 2024 00:00:00 GMTGeneralTom Lazenbyhttp://localhost:4321/blog/cyber-essentials-plus/http://localhost:4321/blog/cyber-essentials-plus/Mayet achieves Cyber Essentials Plus certification, demonstrating advanced cybersecurity practices verified through independent technical audit.Wed, 27 Mar 2024 00:00:00 GMTGeneralNeyts Zupanhttp://localhost:4321/blog/best-practices-digital-integration/http://localhost:4321/blog/best-practices-digital-integration/Best practices for onboarding new software vendors in clinical trials, including API integration strategies and GxP compliance considerations.Wed, 13 Mar 2024 00:00:00 GMTGeneralTom Lazenbyhttp://localhost:4321/blog/critical-to-quality-factors-and-vendor-oversight/http://localhost:4321/blog/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.Wed, 06 Mar 2024 00:00:00 GMTGeneralTom Lazenbyhttp://localhost:4321/blog/gxp-validation-excellence-in-testing/http://localhost:4321/blog/gxp-validation-excellence-in-testing/How Mayet approaches QA testing of GxP computerised systems, bridging traditional CSV and modern Computer System Assurance methodologies.Wed, 28 Feb 2024 00:00:00 GMTGeneralNeyts Zupanhttp://localhost:4321/blog/80-20-of-web-accessibility-for-web-apps/http://localhost:4321/blog/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.Wed, 21 Feb 2024 00:00:00 GMTGeneralDejan Murkohttp://localhost:4321/blog/enhancing-partnerships-financial-analysis/http://localhost:4321/blog/enhancing-partnerships-financial-analysis/How to evaluate the financial impact of vendor services in clinical trials through structured cost-benefit analysis and strategic partnership planning.Wed, 14 Feb 2024 00:00:00 GMTGeneralTom Lazenbyhttp://localhost:4321/blog/digital-integration-in-clinical-operations/http://localhost:4321/blog/digital-integration-in-clinical-operations/A practical guide to strategic digital integration in clinical operations, from ROI assessment to implementation and change management.Wed, 07 Feb 2024 00:00:00 GMTGeneralTom Lazenbyhttp://localhost:4321/blog/rbqm-in-vendor-management/http://localhost:4321/blog/rbqm-in-vendor-management/How Risk-Based Quality Management brings surgical precision to clinical trial vendor oversight, replacing broad-stroke approaches with targeted risk control.Wed, 31 Jan 2024 00:00:00 GMTGeneralTom Lazenbyhttp://localhost:4321/blog/mayet-earns-cyber-essentials/http://localhost:4321/blog/mayet-earns-cyber-essentials/Mayet passes an independent security audit and earns the Cyber Essentials certification, reinforcing our commitment to data protection in clinical research.Wed, 24 Jan 2024 00:00:00 GMTGeneralNeyts Zupanhttp://localhost:4321/blog/new-advisor-chris-shepherd/http://localhost:4321/blog/new-advisor-chris-shepherd/Chris Shepherd, former VP and Head of R&D Quality at GSK and RQA Honorary Life Fellow, joins Mayet as an Advisor.Mon, 15 Jan 2024 00:00:00 GMTGeneralTom Lazenbyhttp://localhost:4321/blog/record-keeping-for-vendor-oversight-compliance/http://localhost:4321/blog/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.Wed, 20 Dec 2023 00:00:00 GMTGeneralTom Lazenbyhttp://localhost:4321/blog/5-common-pitfalls-in-risk-identification/http://localhost:4321/blog/5-common-pitfalls-in-risk-identification/Five mistakes that undermine risk identification in clinical trial vendor management, from subjective bias to overlooking emerging threats.Wed, 13 Dec 2023 00:00:00 GMTGeneralTom Lazenbyhttp://localhost:4321/blog/vendor-oversight-and-data-integrity/http://localhost:4321/blog/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.Wed, 06 Dec 2023 00:00:00 GMTGeneralTom Lazenbyhttp://localhost:4321/blog/gcp-principles-and-vendor-management/http://localhost:4321/blog/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.Wed, 29 Nov 2023 00:00:00 GMTGeneralTom Lazenbyhttp://localhost:4321/blog/gcp-non-compliance-in-vendor-management/http://localhost:4321/blog/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.Wed, 22 Nov 2023 00:00:00 GMTGeneralTom Lazenbyhttp://localhost:4321/blog/the-fire-triangle-part-3-data/http://localhost:4321/blog/the-fire-triangle-part-3-data/Part 3 of the Fire Triangle series on how data, KPIs, and real-time analytics transform vendor management from reactive guesswork to predictive oversight.Wed, 15 Nov 2023 00:00:00 GMTGeneralTom Lazenbyhttp://localhost:4321/blog/fire-triangle-2-communication/http://localhost:4321/blog/fire-triangle-2-communication/Part 2 of the Fire Triangle series exploring communication as the oxygen of vendor management — covering escalation, expectations, and change management.Thu, 09 Nov 2023 00:00:00 GMTGeneralTom Lazenbyhttp://localhost:4321/blog/fire-triangle-part-1-process-playbook/http://localhost:4321/blog/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.Wed, 01 Nov 2023 00:00:00 GMTGeneralTom Lazenbyhttp://localhost:4321/blog/introduction-to-the-fire-triangle/http://localhost:4321/blog/introduction-to-the-fire-triangle/Introducing the Fire Triangle of clinical trial vendor management — the three elements every sponsor needs: communication, processes, and data.Wed, 25 Oct 2023 00:00:00 GMTGeneralTom Lazenbyhttp://localhost:4321/blog/4-common-regulatory-challenges/http://localhost:4321/blog/4-common-regulatory-challenges/Four regulatory challenges sponsors face in clinical trial vendor management, from keeping up with multi-region requirements to demonstrating adequate oversight.Wed, 18 Oct 2023 00:00:00 GMTGeneralTom Lazenbyhttp://localhost:4321/blog/risk-management-frameworks-for-vendor-risk-management-part-3/http://localhost:4321/blog/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.Wed, 11 Oct 2023 00:00:00 GMTGeneralTom Lazenbyhttp://localhost:4321/blog/tools-and-frameworks-for-vendor-risk-management-part-2/http://localhost:4321/blog/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.Wed, 04 Oct 2023 00:00:00 GMTGeneralTom Lazenbyhttp://localhost:4321/blog/tools-and-frameworks-for-vendor-risk-management-part-1/http://localhost:4321/blog/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.Wed, 27 Sep 2023 00:00:00 GMTGeneralTom Lazenbyhttp://localhost:4321/blog/5-pitfalls-in-transfer-of-regulatory-responsibilities/http://localhost:4321/blog/5-pitfalls-in-transfer-of-regulatory-responsibilities/Five common pitfalls when delegating regulatory responsibilities to vendors, including inadequate quality agreements and unclear accountability.Wed, 20 Sep 2023 00:00:00 GMTGeneralTom Lazenbyhttp://localhost:4321/blog/preparation-to-closeout-how-to-optimise-sponsor-oversight-in-clinical-trial-vendor-management/http://localhost:4321/blog/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.Wed, 13 Sep 2023 00:00:00 GMTGeneralTom Lazenbyhttp://localhost:4321/blog/reactive-to-proactive-a-new-approach/http://localhost:4321/blog/reactive-to-proactive-a-new-approach/Why clinical trial vendor management must shift from reactive firefighting to proactive oversight, and how to make that transition practically.Wed, 30 Aug 2023 00:00:00 GMTGeneralTom Lazenbyhttp://localhost:4321/blog/strategic-impact-3-communication/http://localhost:4321/blog/strategic-impact-3-communication/Part 3 of the strategic impact series exploring how structured communication practices drive vendor performance and support clinical trial objectives.Wed, 23 Aug 2023 00:00:00 GMTGeneralTom Lazenbyhttp://localhost:4321/blog/new-advisor-jo-burmester/http://localhost:4321/blog/new-advisor-jo-burmester/Jo Burmester, clinical research training consultant with over 30 years of industry experience, joins Mayet as an Advisor.Fri, 18 Aug 2023 00:00:00 GMTGeneralTom Lazenbyhttp://localhost:4321/blog/strategic-impact-of-vendor-management-and-oversight/http://localhost:4321/blog/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.Wed, 16 Aug 2023 00:00:00 GMTGeneralTom Lazenbyhttp://localhost:4321/blog/aligning-vendor-management-with-strategic-goals/http://localhost:4321/blog/aligning-vendor-management-with-strategic-goals/How aligning vendor risk management with business strategy helps sponsors reduce time to market, cut costs, and decrease inspection findings.Wed, 09 Aug 2023 00:00:00 GMTGeneralTom Lazenbyhttp://localhost:4321/blog/key-processes-effective-qms/http://localhost:4321/blog/key-processes-effective-qms/A deep dive into integrating vendor management processes into your Quality Management System, from selection and qualification to performance monitoring.Wed, 02 Aug 2023 00:00:00 GMTGeneralTom Lazenbyhttp://localhost:4321/blog/maintaining-regulatory-compliance/http://localhost:4321/blog/maintaining-regulatory-compliance/Best practices for maintaining regulatory compliance in vendor management, including the real costs of inspection findings and how to prevent them.Wed, 26 Jul 2023 00:00:00 GMTGeneralTom Lazenbyhttp://localhost:4321/blog/applying-fda-guidance-q9-2023/http://localhost:4321/blog/applying-fda-guidance-q9-2023/Applying the FDA's 2023 Q9 quality risk management guidance to clinical trial vendor oversight, from vendor selection through post-trial activities.Wed, 19 Jul 2023 00:00:00 GMTGeneralTom Lazenbyhttp://localhost:4321/blog/vendor-vs-study-risk-assessment/http://localhost:4321/blog/vendor-vs-study-risk-assessment/Understanding the difference between vendor-level and study-level risk assessments, and why both are essential for effective clinical trial oversight.Wed, 12 Jul 2023 00:00:00 GMTGeneralTom Lazenbyhttp://localhost:4321/blog/welcome-to-mayet/http://localhost:4321/blog/welcome-to-mayet/Introducing Mayet — an all-in-one vendor management platform built to streamline clinical trial outsourcing oversight for pharma and biotech sponsors.Mon, 10 Jul 2023 00:00:00 GMTGeneralTom Lazenby