According to the US Food and Drug Administration (FDA) Phase 1 clinical trials are an increasing $4-$6 Billion global industry. Nucleus Network has built its business to serve emerging biotech customers which represent the fastest growing part of the global clinical development market, accounting for ~80% of the global drug development pipeline.
With the increase in focus and investment in medical research, has come greater scrutiny on the oversight of clinical trials. While all regulatory bodies offer assurance for this oversight, equally as important for pharmaceutical companies is the variation in timeline, cost, documentation required, and feedback received from different regulators, meaning selecting the optimal trial location could have a substantial impact on the feasibility of bringing a product to market. With different requirements for starting clinical trials depending on the jurisdiction, re-examining current processes and partnerships can offer opportunities for improvement, even in already high-performing operations.
Co-authors and speakers, Dr. Graham Wood has extensive experience with clinical trial administration in the USA and Canada, and his insight is augmented with Biljana Georgievska’s in-depth understanding of the regulatory landscape in Australia, and her experience in conducting clinical trials that comply with global reporting standards, in particular with the FDA and European medicines Agency (EMA).
This Webinar and supporting White Paper look at the differences between the three regulatory bodies, and how speed and cost can both be improved by selecting the right location or mix of locations for your clinical trial, without the need to sacrifice quality.
Key Learning Objectives
- Selecting the appropriate Phase 1 trial location to achieve cost, timeline, and quality requirements.
- Leveraging multiple locations in appropriate situations to maximize benefits and create efficiencies, also considering the speed to first-in-human milestone, to be eligible for the next round of investment.
- Selecting partners that understand the advantages and requirements of each regulatory body.
- For biotechnology clients to understand the regulatory path and associated costs for conducting first in human studies in either USA, Australia, or Canada.
- Chief Technology Officer (CTO),
- Chief Medical Officer (CMO),
- Medical Officer,
- Heads of development,
- Heads of research,
- Medical Researcher