What happens when patients and clinical research associates alike can’t—or won’t—go to your clinical trial sites? It’s time for a new plan. In the months since the novel coronavirus brought all normal activity to a halt, clinical trials worldwide have been forced to re-examine their strategies and reconsider their approach to data collection, data monitoring, and e-solutions. Fortunately, there is a clear path already established: Rare disease trials have dealt with these issues for years.
They have found that mHealth and remote monitoring allow patients the convenience of staying close to home, while still providing clean, concise data. Rare disease trials often combine these and other techniques, enabling much to be accomplished remotely—a structure that may be the future of clinical trials.
Join this webinar to learn about how best to run studies remotely and for moving forward with these practices.
Vicki Gashwiler, Executive Director, Specialty Programs, Premier Research
Vicki Gashwiler brings over 20 years of health care experience and 15 years of experience in the medical device industry, both on the sponsor and CRO sides. Prior to her industry experience, Gashwiler began her career as a registered nurse in 2000, working on cardiac, critical care, and out-patient orthopedic surgical units. She started her industry career as a clinical research associate and had the opportunity to advance as a clinical trial manager, project manager, senior project manager, program director, associate director, and director of strategic development & market access. She supported global clinical trials spanning across Europe, Canada, Latin America, Australia, the US, and the Asia-Pacific.
Gashwiler has an extensive understanding of complex trial execution on a global scale, diverse team management, and global regulatory processes and timelines. She has experience in oncology and dermatologic devices, endocrinology, weight management, orthopedics, cardiac and vascular device trials. Additionally, in 2020, she provides Executive Oversight to Premier’s COVID-19 portfolio – a complex mix of studies in both in-patient and out-patient settings.Message Presenter
Anthony Poynton, Senior Director, Program Delivery, Rare Disease & Pediatrics, Premier Research
Anthony Poynton is Premier Research’s senior liaison for clinical research in rare diseases and pediatrics, serving as sponsors’ primary point of contact for these clinical programs and leading teams assigned to these studies. He oversees project scope, schedule, costs, and quality performance to ensure timely project execution and customer satisfaction.
Poynton has 19 years of experience in the contract research, pharmaceutical, and biotech fields. He joined Premier Research in 2016 as Director of Project Management, overseeing efforts to improve customer satisfaction and drive best practices in innovation and continuous improvement. Prior to joining the company, he held similar positions in the areas of rare and orphan diseases, pediatrics, oncology, gastroenterology, nephrology, and dermatology.Message Presenter
Who Should Attend?
Managers and above at biotech and specialty pharma companies with job functions including but not limited to:
- Clinical Operations
- Medical Affairs
- Project Management
- Regulatory Affairs
What You Will Learn
In this webinar, participants will learn:
- Case studies that show remote strategies in action
- Tactics to mitigate and manage risk
- Regulatory guidance concerning remote monitoring
- Skills and processes to request on future RFPs
Premier Research, a clinical research company, is dedicated to helping biotech, specialty pharma, and device innovators transform life-changing ideas and breakthrough science into new medical treatments. As a global company, Premier specializes in the use of innovative technologies for smart study design and trial management to deliver clean, conclusive data to sponsors. Whether it’s developing product lifecycle strategies, reducing clinical development cycle times, securing access to patients, navigating global regulations, maximizing the impact of limited rare disease data, or providing expertise in specific therapeutic areas, Premier is committed to helping its customers answer the unmet needs of patients across a broad range of medical conditions.