HOW JAVARA INC. IS RESPONDING TO COVID-19

March 11, 2020

As the COVID-19 situation evolves globally, Javara has taken additional measures to bolster preparedness in order to continue to provide uninterrupted clinical trial services to its patients, healthcare partners, Sponsors and CROs. Javara’s highest priority is the wellness and safety of its employees and patients and Javara will continue to monitor the situation closely. As additional information becomes available, Javara may update how it is responding to COVID-19. Updates will be made available through Javara’s website at www.javararesearch.com.

KEEPING OUR PATIENTS SAFE

  • Javara follows the protocols implemented by its healthcare partners to identify and respond to patients with signs and symptoms of respiratory infection.
  • Javara monitors each of its sites daily to identify any actual or suspected cases of the COVID-19 virus among its patients, employees and visitors.

KEEPING OUR WORKPLACE AND EMPLOYEES SAFE

  • Employees are continuously reminded of CDC recommendations for everyday prevention.
  • Enhanced cleaning and disinfecting procedures have been implemented at all our facilities.
  • Virtual meeting technology and the ability to work remotely is available to all employees.
  • All business travel is assessed by Javara for risk.
  • Employees who may be travelling to any country designated as a State Department Warning Level 2 or 3 location, will be required to self-quarantine and not access Javara’s facilities for 14 days from the last day in that country.
  • As of March 8, 2020, the CDC and the US State Department recommended against cruise ship travel by way of this notice. As a result, Javara is implementing a 14-day in-office work attendance restriction for employees traveling by cruise ship until the CDC guidance is lifted.
  • At this time, Javara is not restricting outside visitors to its facilities, but Javara will require monitors and other visitors to certify they have not traveled within the State Department Warning Level locations and that they have not traveled via cruise ship as outlined above.

KEEPING YOUR MONITORS SAFE

  • Javara is committed to communicating to Sponsors and CROs any actual or suspected cases of the COVID-19 virus at its sites in advance of monitors coming on site.
  • Javara has implemented a robust technology platform that enables monitors to monitor Javara’s clinical trials remotely. Our technology platform includes:
  • Part 11-Compliant eRegulatory Platform, housing all regulatory documents, approvals and correspondences for our clinical trials.
  • Part 11-Compliant eSource Platform, housing all study data collected during a clinical trial, including the informed consent, labs, and diagnostics, allowing for real-time internal quality assurance review, remote access for CRAs for monitoring purposes and transfer of data from eSource to EDC.
  • Virtual Meeting Technology is available to all Javara personnel.

OUR COMMITMENT TO BUSINESS CONTINUITY

Remote Access

  • All employees who may be required to work remotely have access to a secure computer, broadband and technology support.
  • Employees can remotely access Javara’s electronic platform, including emails, video conferencing capabilities, Part-11 compliant Clinical Trial Management System (CTMS), Part-11 compliant e-Source platform; Part-11 compliant e-Regulatory platform; a central document management system, and Javara’s accounting platform.
  • An experienced Javara Project Manager can be designated to support trial management and conduct across Javara locations including the utilization of a project management tool to allow for sponsor/CRO access remotely.

Remote Patient Accrual and Engagement

  • Patient Portals: As an integrated partner to healthcare organizations, Javara is able to utilize various patient engagement tools such as patient portals and 24/7 care lines to address patient needs, including surveillance and reporting of symptoms in a timely manner.
  • Electronic Health Records: Javara has access to the Electronic Medical Records (EMR) systems of its healthcare partners, providing Javara with the ability to assess and identify patients who meet inclusion/ exclusion criteria for a clinical trial remotely.
  • Telehealth: By utilizing the operating platforms of our healthcare partners, Javara is able to leverage system-based telehealth assets to communicate and conduct clinical assessments with patients when travel or access is limited.
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