COVID-19 and Phase I Studies: Stop. Re-think Everything. Re-start.
Sponsored by: QPS
- Covid 19
Date: 29 October
Time: 8am PST (Pacific Standard Time)
Conducting Clinical Trials During a Pandemic
We are currently in the midst of the greatest global health crisis in decades: the COVID-19 pandemic. As this novel coronavirus affects communities around the world, there is an increasingly urgent demand for available and accurate testing services, effective drug therapies, and a COVID-19 vaccine. However, the implications of a virus like this, where carriers are often asymptomatic while being infectious, presents significant challenges in the conduct of clinical trials designed to develop those effective drug therapies and a COVID-19 vaccine.
At the start of the pandemic, in early 2020, clinical sites operated very cautiously until most global governing authorities required sites to shut down temporarily. During this time, QPS developed rigorous clinic and site reopening plans, and prepared staff to ensure that they were trained on the new procedures and ready to reopen as soon as possible. As a part of those plans, QPS keeps current on the latest guidelines put forth by the CDC, WHO, ECDC, local and state health departments, and complies with those guidelines at all clinical sites, as appropriate.
This webinar will cover content related to the following updated Clinic Procedures altered to ensure safety in the face of COVID-19, such as Screening Study Subjects, Clinical Study Execution, Contingency Planning, and Sample Transport & Testing. We will also discuss the challenges faced with limited capacity in the clinics due to social distancing, and the opportunities presented to squeeze in new vaccine trials.
VP & General Manager – QPS Missouri
An integral part of QPS Missouri since its inception in 1994, Brendon has 26 years of experience in the full range of Operations at this QPS Phase I-IV clinical research facility. In this capacity, he has grown the organization significantly, leading the operational management of 500+ global generic, dermal and NCE clinical trials. Brendon has also been an organizational constituent in 1500+ multi-disciplinary Contract Research Organization teams.
Project Management Specialist
Robin has 22+ years of experience in clinical research, from Start-up and Regulatory needs to final delivery of Clinical Study Reports and Trial Master Files, and everything in between. Robin has an in depth knowledge of clinical trial conduct, safety oversight, marketing and subject recruitment. She develops and manages timelines for projects while ensuring timely and transparent communications, building trust with each of her clients. Robin works with teams globally within QPS to provide clients with the highest level of expertise in the industry. She believes in the QPS Mission to help accelerate pharmaceutical breakthroughs across the globe by delivering custom-built research solutions and takes great pride in being a part of QPS.
Key Learning Objectives
- Understand risk mitigation in the clinic setting
- Understand the tools available to adapt clinics for pandemic safety
- Have a clear view into the steps QPS has taken to keep staff and study volunteers safe
- Clinical Research
- Clinical Operations
- Research and Development
- Drug Development
- Clinical Development
- Clinical Trials Management
- Clinical Trial Operations
- Clinical Trials Project Management