Founders Growth Community - Preparing for Clinical Trials

Please note this workshop is only open to pre-series A life-science and biotech founders. 

Join Founders Growth Community x Innovate Cambridge for their next workshop: Preparing for Clinical Trials – Ensuring Foundational Clinical Compliance for Biotechs.

This talk will help leaders of early-stage Biotechs to understand why they have legal/regulatory responsibilities, once they wish to conduct clinical trials, whether that be soon or in the coming years. We will discuss what processes and systems need to be in place to start clinical activities as a 'compliant Sponsor'. The talk will also explain, and put into context, some of the key jargon used (e.g. GCP, SOPs, QMS, eQMS) as well

Having early awareness of what it actually means for you as a Biotech moving into clinical trials, can help you avoid 'critical inspection findings' from the MHRA/EMA/FDA - which can lead to trial delays & marketing application rejections. if you want to know more, then this talk is relevant to you.

Short Bio of the speakers:

Matt & Steve are dedicated Clinical Operations professionals with significant experience across all aspects of the conduct of clinical trials.

They have a shared experience of leading and developing a Clinical Operations Department - especially the infrastructure/framework needed to ensure robust foundations - during 18+ years at a Start-Up Biotech of 40 people that became a successful mid-sized Pharma of 2000 people (prior to acquisition). They understand the needs of a small Biotech, what is fit-for-purpose, and what the journey ahead may look like as they have been on that journey themselves. Over this time, they were instrumental in the development of two assets that became regulatory-approved medicines and as a result are the veterans of 4 MHRA & 1 FDA GCP Regulatory Inspection(s).

They now apply these unique experiences as the Co-Founders of BlueGreen Clinical.