We are delighted to announce the appointment of Dr. Andrew Copestake as Strategic Advisor to Mayet. With over three decades of executive leadership experience in the pharmaceutical, biotechnology, and CRO sectors, Dr. Copestake brings invaluable commercial and strategic expertise to support Mayet’s growth trajectory. Dr. Copestake on joining Mayet: “Mayet is a unique and sophisticated…

The Evolution of Service Provider Relationships The clinical trial landscape has fundamentally changed. As highlighted at recent industry conferences, including RQA 2024 and COG Europe, the terminology shift in ICH E6(R3) from “CRO” to “service provider” (mentioned 36 times compared to the previous 9) signals more than a simple language update – it represents a…

The Quality Landscape Is Shifting If you’re a quality professional in clinical research, you’ve likely noticed how rapidly the landscape is changing. Between artificial intelligence applications, decentralised trials, and evolving regulatory frameworks, it can feel like you’re constantly playing catch-up. You’re not alone – at recent industry conferences like RQA 2024 and COG Europe, these…

This Blog Post Series – Summarising Recent Conference Themes Over the past few months, I’ve had the privilege of participating in several key industry events, including RQA 2024 in Brighton and COG Europe in Amsterdam. Through presentations, panel discussions, and countless conversations with industry colleagues, several crucial themes have emerged that I believe warrant deeper…

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…