PRA Health Sciences expanded its pharmacovigilance service to offer full post-marketing services for authorized COVID-19 vaccines and therapeutics, including post-authorization safety studies (PASS) delivered by Real World Solutions. PRA can work closely with drug developers and manufacturers in ensuring long-term safety and efficacy of COVID-19 vaccines and treatments.?

“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.”

Leveraging 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 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.

Also, 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.

By using de-identified medical and prescription claims data, PRA longitudinally tracks patients and uses these insights to help improve study design, such as validating protocol inclusion/exclusion criteria against real-world care patterns and identifying physicians who manage high volumes of COVID-19 patients for potential investigator sites.?