Successfully running a clinical trial of a dietary supplement or nutraceutical from beginning to end can be a daunting task. It takes leadership, good communication, and committed teams to ensure a clinical program is executed in a timely manner and to a high degree of quality.
To achieve project goals, it is important to communicate expectations during the initial stages and foster a partnership throughout the trial. There are always risks that must be managed along the way. Understanding what risks may arise and timing of those risks is key in taking a proactive approach to managing a clinical trial. Being prepared for the unexpected provides a pathway to success.
Once a contract is signed to begin a new clinical trial, there are several key milestones along the way. These include: regulatory and/or ethics approval, site initiation, first subject first visits, last subject enrolled, last subject last visit, database lock, results review, and final report. Study start-up—the time when the protocol, consent form, investigators brochure, and regulatory and ethics submissions are written and compiled—is a labour-intensive component of a clinical trial. Time spent planning during this period can prevent changes and delays after study launch.
This webinar will explore the clinical trial timeline from start to finish to help companies considering a trial understand the process and requirements. Discussion points will include the clinical trial timeline, factors affecting timelines and milestones, how to prepare for and overcome common barriers, and how to effectively collaborate with your research partner. The webinar will help address common questions such as what happens when things go wrong and what options are available to overcome problems.
Josh Baisley, B.Sc., Director, Clinical Trials – Domestic, Nutrasource
Joshua Baisley joined Nutrasource in 2013, bringing over 12 years of quality assurance, clinical, preclinical and regulatory natural health product experience and an additional four years of antibody/biologics development experience. Josh has been an active member of the probiotic community as a member of the International Probiotics Association (IPA) Board of Directors, blogging for the IPA, and presenting at the probiotic workshop as well as at the Probiotics Resource Center at SupplySide West in 2016 and 2017 and Vitafoods Europe in 2017.
Having depth in both regulatory filings and project management of clinical trials provides Josh with an understanding of regulatory body thinking and has led to his respected relationship with Health Canada. From 2011-2014, Josh participated on a Health Canada expert working group as a member representing the dietary supplement industry to work toward harmonization of safety reporting for supplements, drugs and biologics. Josh’s regulatory filings throughout his career account for over 10 percent of all applications received by Health Canada’s Natural and Non-prescription Health Products Directorate for clinical research trials. Josh has a Hons. B.Sc. from the University of Guelph, specializing in microbiology and a certificate in regulatory affairs.
Who Should Attend?
- Dietary Supplement/Natural Health Product (NHP) manufacturers
- Pharmaceutical manufacturers (with nutraceutical divisions)
Relevant job areas include:
- Directors and VPs of Clinical R&D and Clinical Operations
- Directors and VPs of Regulatory Affairs
- Directors and VPs of Scientific Affairs
- Presidents, CEOs
What You Will Learn
This webinar will:
- Present the clinical trials timeline for different product types and project goals
- Discuss tools to improve communication of project status between the sponsor and research partner
- Explain key documents that form the backbone of good clinical practice
- Review the cost of quality clinical research
Nutrasource is a full-service contract research organization and consulting firm specializing in health products. With 100+ employees in four offices across three countries, our experienced team partners with sponsors to bring products to market through strategic product development, regulatory and clinical trial consulting and analytical and bioanalytical testing. For a full list of services, visit www.nutrasource.ca.