COVID-19 Global Pandemic
We have prepared well to ensure that there is no disruption to our daily operations carried out on behalf of clients.
Rigorous business continuity planning and pandemic preparedness, coupled with our robust IT infrastructure and data security, have ensured that all our staff can work from home remotely, without any drop in the levels of quality or compliance.
Importantly, given the unique challenges posed by COVID-19 and the SARS-CoV-2 virus, Regulatory and Health Authorities across the world have responded by taking significant measures and have updated their regulations and guidelines. We have taken note of these changes, and any impact to our operations – like processing of ICSRs from clinical trials and post-marketing sources – has been taken into account.
The European Medicines Agency (EMA) has released a ‘Guidance On The Management Of Clinical Trials During The COVID-19 [Coronavirus] Pandemic’, while the U.S. Food & Drug Administration (FDA) has released, ‘Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency’. We are continuously tracking all such updates on upcoming regulations to ensure our clients continue to remain compliant. The dynamic situation requires that all of us stay well informed.