Clinical Trials for COVID-19 Vaccines and Therapies

ProSciento’s clinical research unit (CRU) in Chula Vista, California, is prepared to conduct clinical trials for COVID-19 in healthy subject populations. For more information about expedited enrollment and start start, please visit https://prosciento.com/covid-19-trials/ .

 

Clinical Trial and Patient Treatment Continuity 

During these unprecedented times, ProSciento’s top priorities are patient and staff safety and clinical trial data integrity. We’re pleased to announce that clinical research activities are resuming across our CRO multi-center studies in accordance to amended protocols in compliance with FDA guidance and state and local mandates and in coordination with our clients, partners, and vendors. Clinical research activities are also resuming our specialty clinical research unit (CRU) in Southern California through amended protocols and strict on-site safety measures.

Our COVID-19 Response Team continues to meet daily to assess ongoing safety measures, communicate with study stakeholders, and update clinical trial continuity plans as the COVID-19 situation continues to evolve. 

Early steps taken to mitigate risk with an acute focus on safety and efforts to maintain clinical trial continuity included:

  • 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 expedite 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 had in place preparedness measures that 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. 

For clinical studies conducted at our early phase clinical research unit (CRU) in Chula Vista, California, we worked closely with sponsors and Institutional Review Boards to adapt procedures for treatment and trial continuity. Most studies quickly transitioned to amended protocols, including out-patient study and safety schedules. A example of safety measures instituted at our clinic are listed below. We’re also pleased to announce that we will soon have on-site access to COVID-19 antigen and antibody testing and have already put into place robust testing protocols. Upon having on-site testing, expected in early June, we will resume in-patient CRU operations with safety measures in place and in compliance with FDA guidance and state and local mandates.

To ensure the safety of our staff and study participants, we have taken COVID-19 precautions extremely seriously. Safety measures instituted at our CRU include:

  • COVID-19 antigen and antibody testing protocols for staff and subjects
  • Six-foot social distancing protocol throughout facility
  • Clinic zoning restricted to 10 individuals per area with independent entrance, exit and air flow system
  • MERV-13 HVAC airflow filtration system
  • Temperature and symptoms triage prior to entry for staff and subjects
  • PPE for clinical staff and face clothes for subjects
  • Daily medical grade sanitation of clinic

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 COVID-19@prosciento.com.  

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