KUALA LUMPUR, April 22 (Bernama) -- PRA Health Sciences has announced expansion of its pharmacovigilance solution to offer full post-marketing services for authorised COVID-19 vaccines and therapeutics.
This includes post-authorisation safety studies (PASS) delivered by Real World Solutions, according to a statement.
With thousands of COVID-19 vaccines, therapies, and new and complex modalities under research worldwide, drug developers are in an extraordinarily unique environment that requires speed, accuracy, and transparency of pharmacovigilance and safety data monitoring.
“Our pharmacovigilance solutions enable clients to adhere to regulatory reporting and compliance standards and perform ongoing safety surveillance to ensure the highest level of patient safety,” said PRA Health Sciences Vice President, Pharmacovigilance & Patient Safety, Sabine Richter, Ph.D.
With a global team of over 800 pharmacovigilance and patient safety experts, along with the Center for Vaccines and Emerging Infectious Diseases and the Real World Solutions team, PRA provides a range of services to detect, assess, understand, minimise, and prevent adverse effects or other drug-related risks.
PRA continues to invest in novel approaches and technologies, such as artificial intelligence, automation, and data analytics that can manage large amounts of pharmacovigilance data and ensure near real-time monitoring of safety information.
In addition, using PRA’s Mobile Health Platform, participants can self-enroll into a PASS at the time of vaccination – providing an easy way to report symptoms and provide access to a nurse-led coordination centre to report symptoms that may require follow-up with a healthcare provider.
PRA Health Sciences is one of the world’s leading global contract research organisations by revenue, providing outsourced clinical development and data solution services to the biotechnology and pharmaceutical industries.
-- BERNAMA
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