Patient and Site Monitor Access Has Become a Critical Consideration
With the current high rate of SARS-CoV-2 transmission, which causes COVID-19 to spread exponentially, and with increasingly stringent travel restrictions being implemented daily, sponsors should consider centralized monitoring into their ongoing studies.
“If planned on-site monitoring visits are no longer possible, sponsors should consider optimizing the use of central and remote monitoring programs to maintain oversight of clinical sites.” – FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic
Read also: FDA urges clinical researchers to go virtual in response to COVID-19 pandemic
“The sponsor should reassess risks as the situation develops. This reassessment should also be documented.”
EMA: Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic
“Sponsors should do a risk-assessment and record this internally.”
GOV.UK: Managing clinical trials during Coronavirus (COVID-19)
At Cyntegrity we asked ourselves what we can do to help clinical research teams looking to sustain trial operations and study conduct during a public health emergency such as the current Coronavirus outbreak. It turns out we can do a lot.
We can help:
- establish near real-time centralized monitoring,
- enable the use of 7 “ad-hoc crisis management” Key Risk Indicators (KRIs),
- get your study team well-prepared,
- and mitigate patient safety and study quality risks.
For this reason, Cyntegrity has created a practical guide and COVID-19 RACT catalog providing study teams with mitigation actions against the COVID-19 risk impact on ongoing studies.
We’ve mobilized rapidly to effectively set up a centralized monitoring environment for you. We’re ensuring our service is available to anyone ready to rise to this challenge. We’re contributing as many additional resources as possible at no charge to study teams involved.
We Make Remote Risk Management Accessible to Those Who Urgently Need It
Not to capitalize on this global health crisis Cyntegrity has compiled a special COVID-19 rapid deployment pack, making remote risk management accessible to those who urgently need it.
Download our “Site Visits at Risk? Your Plan B.“ guidance and learn more about our MyRBQM® COVID-19 rapid deployment pack.