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.”
Since the onset of the pandemic, PRA has launched several initiatives to support the global COVID-19 response. PRA Health Sciences’ leadership in digital health enables us to quickly and proactively manage COVID-19 studies and programs, including:
- Expanding the Mobile Health Platform, PRA’s decentralized clinical trials platform, to address sponsors’ needs for virtual COVID-19 studies.
- Managing an unprecedented study start-up timeline that was days rather than months. In 2020, PRA took one study from final protocol to first patient dosed for a COVID-19 therapeutic in just five days – a timeline unheard of in the industry. Within 15 days, the trial scope expanded outside the US and ended with 2,000 patients across 280 sites in 35 countries.
- Launching the COVID-19 Monitoring Program, an end-to-end commercial solution that supports patients and administrators in mitigating impacts of COVID-19 – from education, exposure, testing, monitoring and through recovery. Recently, the program was enhanced with at-home COVID-19 testing capabilities and an AI-based bot service to answer patients’ COVID-19-related questions.
- Conducting ongoing, real-world data analysis of more than 26 million patients who have been exposed, tested, diagnosed with COVID-19, or received a COVID-19 vaccination. By using de-identified medical and prescription claims data, PRA longitudinally tracks patients and uses these insights to 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.
About PRA Health Sciences
PRA Health Sciences is one of the world’s leading global contract research organizations by revenue, providing outsourced clinical development and data solution services to the biotechnology and pharmaceutical industries. PRA’s global clinical development platform includes more than 75 offices across North America, Europe, Asia, Latin America, Africa, Australia and the Middle East and more than 17,500 employees worldwide. Since 2000, PRA has participated in approximately 4,000 clinical trials worldwide. In addition, PRA has participated in the pivotal or supportive trials that led to U.S. Food and Drug Administration or international regulatory approval of more than 95 drugs. To learn more about PRA, please visit www.prahs.com.
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