Posts Category: General

Avoiding TMF Transfer Disasters: A Sponsor’s Survival Guide

Published: 2024/06/05 By: Tom Lazenby
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TMF Retrieval: What Does This Mean? TMF (Trial Master File) retrieval refers to the process of transferring the complete set of documentation related to a clinical trial from a Contract Research Organisation (CRO) back to the sponsor once the study is complete. This documentation is typically stored in an electronic TMF (eTMF) during the study. […]

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What’s In A Name?

Published: 2024/05/24 By: Tom Lazenby
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Why is our company name “Mayet”? I have been asked the following question a lot recently at various events and on calls with clients, so I thought it would be best to write it out for everyone. Choosing the right name for a company is an interesting process. For me it was not just a […]

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Managing Underperforming Vendors

Published: 2024/05/08 By: Tom Lazenby
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Ever been in that position where you’ve picked a vendor who looks shiny on paper but ends up failing to deliver on the primary deliverables? You’re deep in the vendor selection process, wading through proposals, and one vendor stands out, shining brighter than the rest. They talk a big game, promising flawless execution. But as […]

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Vendor Audit Strategy: Perfecting the Process for Peak Performance

Published: 2024/05/01 By: Tom Lazenby
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Effective vendor management through robust auditing strategies is imperative for success. In this blog post I have thought about the critical components and strategic requirements of risk-based and value-based audit strategies. These strategies are crucial for enhancing the efficiency, reliability, and outcome of clinical trials. Understanding how prioritising audit resources, aligning with broader business goals, […]

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Vendor Horror Stories – Conference Recap

Published: 2024/04/24 By: Tom Lazenby
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Welcome back to the Mayet blog! As proud sponsors of this year’s Institute of Clinical Research Ethics and GCP Forum, we had the unique opportunity to engage directly incredible community at the forefront of clinical trials. A special thanks to the Institute for hosting us, to UCL for providing a fantastic venue, and to the […]

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Vendor Qualification: The Key to Ensuring Clinical Trial Success

Published: 2024/04/17 By: Tom Lazenby
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The success of a clinical trial significantly depends on the careful selection and management of external vendors. Vendor qualification is critical to an outsourcing strategy, ensuring that every entity involved in a trial meets the standards required for a successful outcome. This blog post explores the role of vendor qualification in clinical trials, including its […]

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Crafting Compliance in Trial Contracts

Published: 2024/04/10 By: Tom Lazenby
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My perspective and ideas below are informed by my analysis of the EMA GCP Inspection Working Group Report 2022, which underscores the critical role of well-defined contractual agreements in the overarching framework of clinical trial management. The life cycle of a clinical trial is defined by the Protocol and what is required to be delivered, […]

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Best Practices: Clinical Trial Vendor Selection and Qualification

Published: 2024/04/03 By: Tom Lazenby
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Choosing the right vendor is crucial for the success of clinical trials. This blog post serves as a practical guide for Clinical QA professionals, Outsourcing Leads, and Operating Managers embarking on the vendor assessment journey. I’ll cover the complex process of evaluating vendors, covering key areas such as their capabilities, delivery track record, compliance with […]

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Securing Success: Achieving Cyber Essentials Plus

Published: 2024/03/27 Last updated: 2024/04/23 By: Neyts Zupan
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Elevating Our Security Commitment: Mayet Achieves Cyber Essentials Plus Certification We’re proud to announce another significant stride in our ongoing journey towards unparalleled security and compliance: Mayet has been awarded the Cyber Essentials Plus certificate. This achievement not only elevates our security posture but also reaffirms our unwavering commitment to safeguarding the data that fuels […]

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Vendor Onboarding: Best Practices for Digital Integration

Published: 2024/03/13 By: Tom Lazenby
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The integration of digital solutions is critical for organisation success and efficiency, particularly with the growing number and variety of systems available. The prospect of onboarding new vendors and ensuring seamless, robust and compliant software integrations can often seem daunting to pharmaceutical companies. The fear of non-compliance with Good Clinical Practice (GxP) regulations, coupled with […]

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