Fast-Tracking your Phase 1 Clinical Trial in 2022
White Paper & Webinar series
Understanding the regulatory differences between USA, Canada, Australia and the UK.
While all regulatory bodies offer assurance and oversight for clinical trials, the variation in timeline, cost and regulatory feedback means that selecting the right location for a clinical trial can offer significant benefits to the entities sponsoring the trial.
This 24-page white paper explores:
- The differences between the four regulatory bodies in the USA, Canada, Australia and the UK.
- How both the speed and cost of your trial can be improved by selecting the right location without the need to sacrifice quality or regulatory oversight.
- The advantages of selecting the right trial provider for your first-in-human study.
Enter your details below to download the PDF white paper:
(available in English, Chinese & Korean)
About the Authors & Speakers
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).
Author & Presenter
Dr. Graham Wood, Executive VP, Nucleus Network
Dr. Graham Wood is a leader in the conduct and design of clinical pharmacology studies having held senior executive roles in a number of the top clinical research sites in the world.
In total, he has over 22 years of experience and has been involved with more than 200 first-in-human studies as well as over 2,000 studies across all areas of clinical pharmacology. His roles have covered clinical operations, managing a number of clinics throughout North America, leading a team of Project Managers that focused on single and multi-site clinical pharmacology studies and being responsible for integrating innovative technologies or study designs into clinical studies.
After finishing his BSc in Biochemistry, working at National Institute of Health as a Fellow and then completing a PhD in Neurology and Neurosurgery from McGill University, Dr. Wood worked as a Director at MDS Pharma Services, President of Clinical Operations at Cetero Research, CEO of Manna Research and Chief R&D Officer at Altasciences as well as spending two years in executive roles at biotechnology companies.
Author & Presenter
Biljana Georgievska, Director of Clinical Operations, Nucleus Network
Biljana Georgievska has over 15 years extensive global experience in strategic and operations clinical research management, specializing in the development of clinical trials of novel therapeutic cancer therapies and Phase 1 healthy volunteer clinical trials.
Her in-depth knowledge and understanding of the USA and Australian markets has been instrumental in her ability to form strong results-driven relationships with biotechnology and pharmaceutical clients.
Biljana’s customer-centric approach translates to best possible outcomes for our clients and, this approach is furthermore instilled within her leadership values.
Biljana has significant experience in North America, as the Director of operations at The Pediatric Early Phase Clinical Trial Network (PEP-CTN). This is a consortium comprised of 21 premier Children Oncology Group (COG) pediatric core member sites across the USA and Canada.