Although many trials hit “pause” when the pandemic disrupted everyday life, the clinical research industry pivoted quickly and definitively, moving as many trials as possible back on track, while streamlining the process and maintaining (or even improving) patient and data integrity. At Synteract, we were able to transition swiftly and keep studies progressing, getting creative with troubleshooting options and closing studies without significant impact in timelines.
If your dermatology trial encountered challenges since the pandemic struck – or if you are wondering how to resume or start new trials – join this webinar presented by Synteract Dermatology team experts Betsey Zbyszynski the senior director of strategic development in dermatology, Nancy Fitzgerald the biostatistics director, and Craig Dorer-Abadia, the director of dermatology project management.
Together, they will address the current dermatology landscape, the impact of COVID-19 on trials and the “new norm,” and examine how some sponsors are responding. Our speakers will share insights on how Synteract has been able to realign and adapt quickly and with minimal disruption – offering case studies and site status updates, including how the company was able to achieve eight database locks in the last four months.
Betsey Zbyszynski, Senior Director, Strategic Development, Dermatology, Synteract
Betsey Zbyszynski has over 25 years of experience in clinical research and 18 years in dermatology. She has an extensive background in clinical monitoring project management, and strategic development. Her areas of expertise include dermatology therapeutics, cosmetic dermatology and ophthalmology.Message Presenter
Nancy Fitzgerald, Biostatistics Director, Synteract
Nancy Fitzgerald has over 21 years in dermatology clinical development and biostatistical analysis. She has extensive experience with interactions with regulatory authorities, study development, clinical operations, data management, statistical analyses, medical writing, quality and auditing. She has managed programs resulting in 44 approvals, including 20 NDAs and 11 ANDAs.Message Presenter
Craig Dorer-Abadia, Director, Project Management, Dermatology
Craig Dorer-Abadia has 19 years of clinical research expertise in building and operationalizing processes across all phases of dermatology drug development. He cultivates investigator site relationships across North America, and has a deep knowledge of dermatology indications such as acne, psoriasis, atopic dermatitis and fungal infections, including onychomycosis.Message Presenter
Who Should Attend?
This webinar will appeal to VPs, Directors, Managers, Department Heads, Scientists and Researchers working in dermatology drug development:
- Clinical Affairs
- Clinical R&D
- Clinical Research
- Clinical Pharmacology
- Clinical Operations
- Project Management
- Regulatory Affairs
- Medical Affairs
What You Will Learn
In this webinar, participants will learn about:
- Actionable steps to develop new SOPs and remote integration
- Important changes to consider that will impact trials during and after the pandemic
- COVID-19 impact on clinical development from a statistical perspective
- Considerations for the statistical analysis of the primary and key secondary endpoints in a trial affected by COVID-19
With employees across 21 countries, Synteract is an innovative, full-service CRO supporting biopharma companies across all phases of drug development to help bring new medicines to market. Synteract has conducted 4,000 studies on six continents and in more than 60 countries, working with more than 26,000 investigative sites and 750,000 patients. Greater than 245 of its 4,000 studies have been in pediatric populations. In addition to pediatrics clinical trials, Synteract offers a notable depth of therapeutic expertise in dermatology, neurodegenerative, oncology and immunotherapy, and rare/orphan disease studies.