PRA Health Sciences expands its response to COVID-19 with pharmacovigilance solutions for authorized vaccines and therapeutics

PRA offers post-authorization safety solutions to keep up with the speed of COVID-19 vaccine and therapeutic pharmacovigilance requirements

RALEIGH, N.C., April 21, 2021 (GLOBE NEWSWIRE) -- PRA Health Sciences (NASDAQ: PRAH) announced today the expansion of its pharmacovigilance solution to offer full post-marketing services for authorized COVID-19 vaccines and therapeutics, including post-authorization safety studies (PASS) delivered by Real World Solutions. With more than 25 years of experience executing comprehensive pharmacovigilance and patient safety services in all key therapeutic areas including infectious diseases, PRA can work closely with drug developers and manufacturers in ensuring long-term safety and efficacy of COVID-19 vaccines and treatments.

With thousands of COVID-19 vaccines, therapies, and new and complex modalities under research around the world, drug developers are in an extraordinarily unique environment that requires speed, accuracy, and transparency of pharmacovigilance and safety data monitoring.

“As more COVID-19 vaccines and therapeutics are approved, Marketing Authorization Holders will have massive volumes of safety data to review and report in almost real-time,” said Sabine Richter, Ph.D, Vice President, Pharmacovigilance & Patient Safety, PRA Health Sciences. “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.”

With a global team of more than 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, minimize, 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 center to report symptoms that may require follow-up with a healthcare provider.

“The global COVID-19 vaccination and therapeutic response is one of the largest public health programs of our lifetimes. Near real-time safety data and analysis is critical to quickly identifying, assessing and preventing drug-related risks,” said Greg Licholai, Senior Vice President and Chief Medical Information Officer, PRA Health Sciences. “PRA’s Mobile Health Platform and pharmacovigilance solutions are examples of PRA’s commitment to patient-first approaches to clinical research and healthcare delivery.”