During these unprecedented times, ProSciento’s top priorities are patient and staff safety and acting responsibly to mitigate the spread of COVID-19. We are continuously monitoring COVID-19 developments and guidance from the World Health Organization, Centers for Disease Control, Institutional Review Boards, and state and local authorities. Earlier this year we formed a ProSciento COVID-19 Response Team to prepare readiness measures across all studies and sites in coordination with our clients, partners, and vendors. The Response Team meets daily to assess safety measures, communicate with study stakeholders, and update clinical trial continuity plans as the COVID-19 situation evolves.
Proactive steps to mitigate risk with an acute focus on safety and efforts to maintain clinical trial continuity include:
- Working with clients, sites and vendors to proactively to activate and update business and clinical trial continuity plans to adapt to the COVID-19 impact
- Coordination with sites and vendors to assess preparedness and implement gap measures
- Daily status reviews of clinical projects and development of alternative study schedules to prepare for and respond to triggering events
- Coordination with Institutional Review Boards to expediate amendment reviews
- Monitoring and adhering to the evolving mandates and guidance of federal, state and local authorities, as well as coordination with the city public health department
- Remote status and additional precautionary measures for staff
With the experience of 16+ years and more than 300 clinical projects, we have in place preparedness measures that have allowed us to respond promptly and responsibly. Although these are unprecedented times that have impacted our business, we are committed to act in an advisory role to help support business continuity for our industry as a whole, and, importantly, to support efforts by health authorities to mitigate and respond to the impacts of COVID-19.
In response to the order from the State of California Governor on March 19 that instructs anyone living in the state to stay home except for those providing essential services, we have temporarily closed our Chula Vista, California early phase clinical research unit (CRU). We are safely transitioning study participants to out-patient study and safety schedules and working closely with sponsors and Institutional Review Boards to adapt procedures for treatment and trial continuity. We are monitoring the federal, state and local COVID-19 mandates and guidance closely and communicating with the local public health office. Normal CRU operations are expected to resume in approximately two months; however, this could change based how the US COVID-19 situation evolves.
The multi-center studies managed by our CRO business unit and the sites involved in those studies may be affected differently. We are working with clients, sites and vendors to ensure study continuity as much as possible and in compliance with FDA guidance and state and local mandates.
During these challenging and uncertain times, we are grateful for our tremendous team, partners and clients as we work together swiftly and responsibly to ensure patient safety and treatment continuity in response to the impacts of COVID-19. Together, we remain committed to our mission of finding new treatments for diabetes, NASH, obesity and related metabolic diseases.
For questions or additional information, please contact us at COVIDemail@example.com.