Moving towards clinical trials? Understanding your responsibilities and putting the right foundations in place early can make a significant difference.
The Founders Growth Community and Innovate Cambridge are hosting you for a practical session exploring what it really means to become a compliant clinical trial Sponsor.
Led by Matt and Steve, Co-Founders of BlueGreen Clinical, the session will cover:
- Your legal and regulatory responsibilities as a clinical trial Sponsor
- What GCP, SOPs, QMS and eQMS mean in practice
- The processes and systems that should be in place before clinical activity begins
- Common compliance risks that can lead to inspection findings, trial delays and regulatory challenges
- How to build systems that are appropriate for an early-stage biotech without overcomplicating them
Matt and Steve bring extensive experience in Clinical Operations. During more than 18 years at a start-up biotech that grew from around 40 people into a 2,000-person pharmaceutical company, they helped build the clinical infrastructure needed to support that growth. They also contributed to the development of two regulatory-approved medicines and supported multiple MHRA and FDA GCP inspections.
This workshop is designed specifically for pre-Series A life science and biotech founders. Whether clinical trials are approaching or remain several years away, it offers an opportunity to understand what your organisation should be thinking about and putting in place now.
Register here: https://www.tickettailor.com/checkout/view-event/id/8901980/chk/b812b003b0b669cef33e13ca469fb4e3/