In September 2024, the FDA finalised its guidance on conducting decentralized clinical trials (DCTs) and integrating decentralized elements into traditional trial models. This new guidance aims to address evolving practices in clinical trials that leverage remote methods, digital health technologies (DHTs), and decentralized service providers. The primary goal? To make trials more accessible, efficient, and…

Managing service providers effectively is critical. Ensuring quality, compliance, and operational efficiency while maximising return on investment (ROI) is critical for Sponsors. However, there is a fine line between effective oversight and micromanagement, where too much oversight can lead to frustration, decreased trust, and ultimately, a breakdown in the relationship between sponsors and service providers.…

In what can only be described as my longest blog post yet, I am also providing you with a contents below with links to skip to the sections that interest you the most. Decentralized Clinical Trials (DCTs) offer a new approach that was accelerated by the COVID-19 pandemic. These trials utilise digital tools and local…

I am writing this blog post as a response to a poll which I ran on LinkedIn recently. The post explored the new challenges in Sponsor Oversight based on the upcoming implementation of ICH GCP E6 R3, based on the current draft we all have access to. As you can see from the results in…

Anyone who has met me knows that I love to learn, and when I read about something new that interests me I can disappear down a rabbit hole of research for days. I also repeatedly turn to different industry sectors for inspiration on what I can learn, and how that can be applied to our…

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…