COVID-19 UPDATES

 

March 18, 2020

 

In light of the current global situation with COVID-19, Innovaderm’s focus is on the well-being and safety of our employees and patients, supporting business continuity for us and our customers, and ensuring that our studies continue to be conducted in compliance with applicable regulations. We are surveying health authorities, and we will continue to monitor this situation and adjust our response as may be necessary or required. Innovaderm wants to assure its sponsor and employees that contingencies plans are in place to enable business to continue as usual.

 

Innovaderm is following Health Canada and Centers for Disease Control (CDC) guidance and is recommending to all CRO Operations employees able to work from home to do so immediately until further notice. Where possible, public transit, air and rail travel will be discouraged in regions with known outbreaks.

 

Face-to-face meetings are being replaced with teleconferences or video conferences, until such time as the risk of infection is reduced to acceptable levels. For studies planning investigator meetings during the COVID-19 outbreak, it is being recommended that the study teams consider with the Sponsor conducting virtual investigator meeting rather than a physical onsite meeting.

 

Innovaderm will contact vendors and sites on active trials to obtain their COVID-19 business continuity plan. Innovaderm CRAs will work with sites individually to assess whether onsite monitoring visits should be changed to offsite/remote monitoring visits to maintain oversight on quality and data integrity. Innovaderm will remain nimble and adapt monitoring resourcing strategies as required.

 

Innovaderm will continue to review our business continuity plan and adjust as needed.

 

Further updates and information about Innovaderm’s response to COVID-19 will be shared on this webpage.

 

For COVID-19 criteria, visit the following websites:

NEW!! FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic:

http://www.fda.gov/media/136238/download

Health Canada:

http://www.canada.ca/en/public-health/services/diseases/2019-novel-coronavirus-infection/canadas-reponse.html

CDC:

http://www.cdc.gov/coronavirus/2019-ncov/index.html

WHO:

http://www.who.int/emergencies/diseases/novel-coronavirus-2019