Since clinical trial outsourcing emerged in the late-20th century, there have been significant shifts in its approach and benefits. Driven by evolving regulatory requirements, technological advancements, and changing business needs, outsourcing in clinical trials has allowed organisations to enhance efficiency and reduce costs. If you already understand outsourcing models in detail, then it is worth…

This blog post is inspired by an analogy brought up by Terttu Haring from Syneos who was sitting on a panel discussion. Terttu interestingly compared outsourcing strategies and selection of service providers with how we do grocery shopping (I’ll clarify below). This made me think more about the end-to-end process of vendor management and oversight…

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.…

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…

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…

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,…

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…

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…

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,…

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…