As we continue to monitor the global COVID-19 pandemic, Ora remains focused on our commitments to customers and patients while adjusting operations as necessary for the health and wellness of all involved. Open communication is important during these times, therefore we are summarizing Ora’s plans below and will keep you informed, should the situation change.
- Ora’s global Emergency Response Management Team (ERMT), comprised of global leaders across many functions, meets on an as-needed basis to monitor the situation and ensure enterprise-wide readiness as the issue evolves.
- All employees have received specific guidance with a communication plan to follow if there is reason to believe they or someone in their household has been infected with the virus.
- Ora began a primarily work-from-home policy starting on March 16. This is being assessed daily by our ERMT based on current government orders, in particular for our Headquarters in Andover, Massachusetts. Ora is exempt from the Massachusetts stay-at-home advisory, however most employees will continue to work from home during this time. Our office and preclinical laboratory will remain open to facilitate employees who are deemed essential in order to continue mission critical activities that ultimately help patients. To reduce risks for these employees, we are implementing deeper and more frequent facility cleanings.
- Ora’s secure IT infrastructure includes partnering and collaboration tools to enable employees to continue working together efficiently across the globe.
- The FDA recognizes that protocol modifications may be required, and that there may be unavoidable protocol deviations due to COVID-19 illness and/or control measures, thus they have issued guidance regarding trial conduct that we are reviewing and implementing when possible and applicable.
- We have temporarily suspended all non-essential business travel. All business-critical travel that supports the delivery of client projects continues, as long as there are no government mandates in place that prevent employees from travelling to a particular area.
- Ora study teams are communicating with sites and regulatory agencies to determine the potential impact, if any, on study timelines. Where there are instances of foreseen delays, our teams are working with sponsors to develop study-specific plans to minimize risk.
- Ora’s Therapeutic Heads and Medical Monitors are assessing the impact of COVID-19 on patient safety and IP dosing compliance and are formulating mitigation strategies with Project Managers and with Sponsor medical and operational teams.
- In-person monitoring visits are continuing – in certain circumstances, we have implemented remote monitoring strategies (with sponsor approval) and study-specific monitoring plans to meet the needs of our individual programs.
We will continue to assess the impact of COVID-19 on our operations and regularly communicate any developments to our partners.