FDA Recommends Remote Monitoring

Sep 1, 2011Clinical Trial

In this technological age, monitoring clinical trials done remotely, and no longer requires traveling to a destination to check up on the investigators. The FDA, is encouraging sponsors to undertake more of what the agency calls risk-based monitoring in order to match international standards articulated by the International Conference on Harmonisation. Read the full article about the FDA encouraging remote monitoring.

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March 25, 2021 – Update on COVID-19 (“Coronavirus”)

To: Our Sponsors, CROs, Patients, and Employees

The top priorities of CenExel Clinical Research are the safety and health of our patients and employees. Our Centers of Excellence provide the highest quality of clinical research. CenExel has established and maintains a COVID-19 Task Force with representatives from every Center. The Task Force is charged with continuous monitoring of the pandemic and providing guidance and communication to our patients and employees to ensure their safety.

Our clinical operations continue, and we have implemented the following additional safety measures:

We enhanced screening of everyone entering any of our facilities before they are admitted into our offices or clinical areas.
We reinforced internal communication regarding the COVID-19 situation, CDC and SHRM recommendations, digital team meetings, and the importance of using sick leave for anyone who has signs, symptoms, or recent exposure to someone with suspected or diagnosed COVID-19.
We provided additional cleaning and disinfecting materials through our clinic and office areas.
Managers and leaders have cross-trained employees and prepared for contingency plans if key staff need to stay home.
We established a 14-day, self-quarantine rule for any staff returning from a country with a Level 3 Travel Health Notice from the CDC.

We will continue to monitor the current situation, coordinate with the proper authorities, and update our policies and procedures as needed to ensure the safety of our patients and employees.

FDA Recommends Remote Monitoring

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​March 25, 2021 – Update on COVID-19 (“Coronavirus”)

To: Our Sponsors, CROs, Patients, and Employees

March 25, 2021 – Update on COVID-19 (“Coronavirus”)