PRA Health Sciences has expanded its pharmacovigilance solutions to include a broader range of post-marketing services geared toward authorized vaccines and therapeutics for COVID-19. The offerings are designed to enable drug developers to keep up with the speed, accuracy and transparency demands of pharmacovigilance and safety data monitoring associated with COVID-19 treatments and vaccines.
Sabine Richter, vice president of pharmacovigilance and patient safety with PRA, said, “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. 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.”
PRA reportedly staffs more than 800 pharmacovigilance and patient safety experts around the globe (along with its Center for Vaccines and Emerging Infectious Diseases, and Real World Solutions team. It also employs artificial intelligence, automation, and data analytics to help manage sizeable amounts of pharmacovigilance data, in order to facilitate near-real-time monitoring of safety information.
Participants can utilize the company’s Mobile Health Platform, and self-enroll into a post-authorization safety study (PASS) when they are vaccinated. This provides a straightforward way to report symptoms, and gain access to a nurse-led coordination center should symptoms that require follow-up with a healthcare provider emerge.
“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, PRA’s senior vice president and chief medical information officer. “PRA’s Mobile Health Platform and pharmacovigilance solutions are examples of PRA’s commitment to patient-first approaches to clinical research and healthcare delivery.”
The expansion of its COVID-19 pharmacovigilance offerings is the latest in PRA’s initiatives designed to support COVID-19 response. Others include:
- Expanding PRA’s decentralized Mobile Health Platform
- Helping execute a COVID-19 therapeutic study start-up timeline in days, rather than months
- Launching its COVID-19 Monitoring Program, supporting patients and administrators in mitigating COVID-19 impact
- Conducting ongoing, real-world data analysis of more than 26m patients that had been exposed, tested, diagnosed with COVID-19, or received a COVID-19 vaccination.