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

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.

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 Relations
hurstlaurie@prahs.com | +1 (919) 786–8435


GLOBENEWSWIRE (Distribution ID 8221129)

PRA Health Sciences selected by Maryland State Medical Society to supply remote patient monitoring and telehealth services

RALEIGH, N.C. and BALTIMORE, April 13, 2021 (GLOBE NEWSWIRE) — PRA Health Sciences (NASDAQ: PRAH) and the Maryland State Medical Society (MedChi) announced today that Care Innovations, a PRA Health Sciences company, was selected by MedChi to be a preferred provider of remote patient monitoring, telehealth, and digital health services for its network of 22,000+ licensed physicians who practice across 50+ medical specialties. Maryland physicians now have a trusted provider to quickly deploy a secure and privacy–compliant system for maintaining patients' care remotely, including routine visits and chronic disease management.

"This is the time to embrace RPM to manage patient care," said Gene Ransom, Chief Executive Officer, MedChi. "The pandemic has proven the clinical and economic benefits of remote patient monitoring and physicians are in search of the right vendor to support this long–term, virtual model. MedChi is pleased to help physicians quickly select a comprehensive provider and expand patients' access to these vital services."

Remote patient monitoring is an important component of healthcare that contributes to better patient outcomes and higher patient satisfaction. By capturing medical information automatically and remotely, RPM offers comprehensive, patient–centric care, particularly for elderly and high–risk patients. In today's pandemic environment, RPM can help patients avoid exposure to COVID–19 and reduce emergency room visits and hospitalizations by evaluating patients' health information from the comfort of their home.

By selecting Care Innovations, physicians will receive the physician and patient–facing technology, including the remote patient monitoring platform, Health Harmony mobile app, nurse–led coordinating center, and internet–connected devices, such as blood pressure cuffs, pulse oximeters, and glucometers. Patients can use these medical devices and the mobile app to manage their care at home, while their physicians monitor the data remotely. In addition, physicians can elect for monthly care management, which allows for billing for services pertaining to Medicare CPT RPM codes for patients that meet the requirements.

"Remote patient monitoring and telehealth offer an innovative way for physicians to monitor their patients' health in near–real time without travel or time constraints," said Randy Swanson, Senior Vice President at PRA Health Sciences and President of Care Innovations. "PRA's digital health solutions provide the infrastructure, technology and payer reimbursement plans to support physicians' practice requirements and patients' healthcare needs."

For more information or to enroll these services today, Maryland physicians can visit CareInnovations.com or MedChi page.

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 19,000 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 Relations
hurstlaurie@prahs.com | +1 (919) 786–8435

About the Maryland State Medical Society

MedChi, The Maryland State Medical Society, is a non–profit membership association of Maryland physicians. It is the largest physician organization in Maryland. The mission of MedChi is to serve as Maryland's foremost advocate and resource for physicians, their patients and the public health of Maryland. For more information, please visit www.medchi.org.


GLOBENEWSWIRE (Distribution ID 8215433)

PRA’s remote patient monitoring platform selected by Merck KGaA, Darmstadt, Germany to work in combination with its human growth hormone treatment system

RALEIGH, N.C. , April 07, 2021 (GLOBE NEWSWIRE) — PRA Health Sciences (NASDAQ: PRAH) announced today that Merck KGaA, Darmstadt, Germany, known in the United States as EMD Serono, selected PRA's remote patient monitoring platform to work in combination with its human growth hormone (HGH) treatment system. Under this agreement, PRA's remote patient monitoring platform backs Merck KGaA, Darmstadt, Germany's HGH treatment system, including growlinkTM, a mobile app for patients prescribed with HGH treatment, and easypod Connect, a secure platform for healthcare professionals (HCP) in the field of endocrinology to monitor patients' adherence, review injection history, and share information about patients' progression with growth hormone disorder.

"Patients and payers expect us to offer new technologies, such as treatment–supporting apps, with the highest levels of privacy and data security," said Andre Musto, Senior Vice President and Head of Cardiovascular Metabolism & Endocrinology, Merck KGaA, Darmstadt, Germany. "With growlink and easypod Connect, supported by PRA's remote patient monitoring platform, we can offer patients innovative tools to help manage their condition and assure payers of the effective use of treatments while fully respecting their privacy and data security."

Human growth hormone treatments are frequently prescribed for children and adolescents with growth hormone deficiency, a condition that impacts approximately 1:4,000 to 1:10,000 children1 each year in the U.S. Despite the prevalence of growth hormone deficiency and treatment options, one of the biggest challenges is ensuring patients' adherence to the regimen. Adding this layer of technology to HGH treatments better facilitates patient engagement, helps HCPs make better use of patient visits, and ensures the treatment is taken regularly and at the right dosage, optimizing treatment outcome and driving payer confidence.

In a real–world setting, an HCP would use easypod Connect to invite patients to download the mobile app, growlink. Then the patient downloads the mobile app, signs an eConsent form on the app, and syncs the app with Merck KGaA, Darmstadt, Germany's HGH injector medical device, easypod. This device is able to self–regulate the appropriate dosage of HGH based on the treatment protocol. The four–part system "" Merck KGaA, Darmstadt, Germany's mobile app (growlink), connected device (easypod), and HCP platform (easypod Connect ) underpinned by PRA's remote patient monitoring technology "" enables HCPs to see an accurate picture of patients' adherence, height, weight, and other outcomes while offering patients a more convenient way to follow to their treatment regimen and manage their condition.

"For many years, PRA has been focused on designing an end–to–end digital health platform that supports mobile healthcare delivery, such as remote patient monitoring," said Kent Thoelke, Executive Vice President and Chief Scientific Officer, PRA Health Sciences. "Our collaboration with Merck KGaA, Darmstadt, Germany to support growlink and easypod Connect is an example of how the industry is advancing with the patient at the center of our innovation."

PRA hosted a webinar called, How Digital Therapeutics and Remote Patient Monitoring Can Drive Pharmaceutical Product Differentiation, to help create differentiation. Access the replay webinar today.

For more information about PRA's remote patient monitoring solutions, visit www.prahs.com.

1 Stanley T. Diagnosis of Growth Hormone Deficiency in Childhood. HHS Public Access. Available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3279941/

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 19,000 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 Relations
hurstlaurie@prahs.com | +1 (919) 786–8435


GLOBENEWSWIRE (Distribution ID 8213058)

PRA’s Center for Rare Diseases Launches Toolkit to Identify and Mitigate Risks to Rare Disease Clinical Programs

RALEIGH, N.C., March 22, 2021 (GLOBE NEWSWIRE) — PRA Health Sciences (NASDAQ: PRAH) announced today the launch of its Patient–Centric Trial Development Toolkit, available now to clinical development sponsors focusing on rare diseases. Developed by PRA's Center for Rare Diseases in collaboration with PRA's Rare Disease Advisory Committee (RDAC) and other patient stakeholders, the toolkit includes four digital resources designed to mitigate risks that frequently occur in rare disease clinical trials. The toolkit also introduces and affirms new patient–centric practices that promote trial participation.

The Patient–Centric Trial Development Toolkit is available at no cost and can be downloaded at https://prahs.com/insights/patient–centric–trial–development–toolkit.

"The main purpose of the toolkit is to guide sponsors in taking a more patient–centric approach in developing clinical trials," said Scott Schliebner, MPH, Senior Vice President, Center for Rare Diseases at PRA Health Sciences. "As an example, the toolkit includes a risk assessment tool that clinical development teams can use to identify risk to the efficiency of a clinical program. The risks that are identified are usually real world burdens for participants, and the tool provides risk mitigation strategies and solutions for sponsors to consider."

PRA's rare disease experts and RDAC members recognized a gap in the availability of structured tools for operationalizing patient–centricity in rare disease clinical development. Patients, advocates, and industry leaders in rare diseases collaborated and consulted with PRA to develop four parts of the Patient–Centric Trial Development Toolkit:

  • Patient–Centric Protocol Risk Assessment Tool: Interactive, spreadsheet–based tool that enables sponsors to rapidly identify potential risks, track evolution of risk assessment through stages of the development process and identify potential mitigation strategies.
  • Rapid Participation Burden Survey Tool: An easy–to–use questionnaire development guide that helps sponsors and patient advocates develop a rapid survey for patients and caregivers tailored to their clinical trial's specific context. The aim of this tool is to help sponsors quantify risk to the clinical program through direct patient engagement.
  • Patient Involvement Value Dossier: This tool outlines the evidence of ROI/benefit involvement in the trial development process from extant literature and provides illustrative case studies from PRA's Center for Rare Diseases.
  • "What to ask when you're interested in a clinical trial: A Guide for Rare Disease Patients and Caregivers": Helps prospective participants identify the barriers to participation they may encounter and request the support they need to enroll and stay in the trial.

"Rare disease patients and trials face unique challenges compared to those in more common indications," said Tracy Dixon–Salazar, PhD, Director of Research & Strategy at LSG Foundation, RDAC member. "As a rare disease patient advocate, I appreciate the genuine care that PRA gives to their patients and family caregivers. In sharing these resources with sponsors and the rare disease community, PRA is taking another step in making clinical research more accessible and ensuring the patient and their family is top of mind when developing a clinical trial program."

"PRA is so sincerely dedicated to putting the patient's experience first," said Terry Jo Bichell, Founder & Director of COMBINEDBrain, RDAC Member. It is easy to give lip service and small concessions to patients, but PRA is actually digging deep into what it means for patients and their families to be a part of clinical trials. Even when a patient wants a new treatment, it is still stressful, scary, and time–consuming to take part in a trial. PRA is trying to understand that and make it better."

While the Patient–Centric Trial Development Toolkit does focus on lessening the burden on patients to participate in clinical research, there are also several key benefits for sponsors such as avoiding significant costs related to inefficiency, high trial dropout rates, protocol amendments, and not being able to complete a trial on time.

To learn more about the importance of patient–centricity in clinical development or to download the toolkit, visit https://prahs.com/centers/center–for–rare–disease/trial–development–toolkit.

For more information about the Center for Rare Disease, please visit https://prahs.com/centers/center–for–rare–disease.

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 approximately 19,000 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 Relations
hurstlaurie@prahs.com | +1 (919) 786–8435


GLOBENEWSWIRE (Distribution ID 8204269)