PRA Health Sciences expands its response to COVID-19 with pharmacovigilance solutions for authorized vaccines and therapeutic...
April 21 2021 - 4:02PM
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.
Please visit PRAHS.com for more information about PRA’s
pharmacovigilance solutions, patient safety solutions specific to
COVID-19, and ways PRA is helping clients navigate COVID-19.
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.
INVESTOR INQUIRIES: InvestorRelations@prahs.com
MEDIA INQUIRIES: Laurie Hurst, Sr. Director, Communications and
Public Relationshurstlaurie@prahs.com | +1 (919) 786-8435
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