Safety & Risk Management

Minimizing patient risk is crucial as we endeavor to bring new medicinal products to the marketplace. Now more than ever, regulatory authorities emphasize the importance of a comprehensive safety infrastructure. The development of risk minimization strategies suitable for the whole life cycle of the medicinal product is imperative.

We are problem solvers. Flexible, innovative, and nimble. We can provide sponsors a customized solution that insures data quality and minimizes risk to patients.

Jonathan M. Fishbein, M.D. – Senior Vice President, Safety and Medical Affairs/Commercialization Services

We Are Dedicated To Minimizing Risk And Protecting Patient Safety

PRA’s Safety & Risk Management group has an impeccable record of providing a comprehensive range of pharmacovigilance services throughout the product life cycle. PRA provides global coverage with six centralized Drug Safety Centers in Europe, Asia and the Americas to ensure patient safety and ultimately save resources. PRA’s Safety & Risk Management teams work in a cross-functional fashion with other solution areas such as Post-Marketing and Therapeutic Expertise to better assist clients in the effective management of their drug safety information.

01
Pharmacovigilance Systems & Technology

Be Effective.

The ability to effectively monitor safety requires a thorough and complete collection of high quality data during the entire product lifecycle. Sophisticated yet versatile technology facilitates the gathering and analysis of data, so risks are detected early and patient safety is maximally protected.

An electronic data capture (EDC) system collects and transfers safety data using gateway solutions. Our highly trained safety specialists operate our signal detection software and permit the review of individual patient profiles and aggregate data. We can inform regulatory authorities and other stakeholders of safety information both electronically and instantaneously. Our electronic tracking system provides transparency of our compliance with global regulations during audits and inspections, far surpassing the limited capabilities of commercially available safety databases. Alternatively, if you prefer to manage critical safety data with your in-house systems, our teams have the know-how to operate in your environment. For those sponsors who prefer to meet safety needs with a less technological approach, PRA will seamlessly employ processes to effectively and accurately meet your pharmacovigilance needs.

Efficient technology operated by expert staff enables PRA to offer effective pharmacovigilance solutions.

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Whether you prefer a high tech or a low tech approach, PRA believes that success lies in the skills and fortitude of the operator. The dedication and knowledge of our teams is second to none, reinforcing our core belief that we must first and foremost be patient-centered in all aspects of our clinical trials. Together, we can customize a safety solution tailored to your specific needs.

02
Case Management

Be Complete. Case Management is a resource intensive, critical function in any organization. At PRA, we take pride in our devotion to quality. Our approach to excellence starts with our attention to the four “C’s”: Consistency, Correctness, Compliance, and Completeness. Our processes permit us to work efficiently, so we can provide you with excellent, cost-effective solutions for your case management needs, regardless of complexity or caseload. Solutions_Safety_Risk_Management_Approach_to_Excellence_Case_Management_Graphic To enhance our “be complete” case management efforts, our safety team immediately scrutinizes each and every adverse event/reaction captured in the product lifecycle. We are mindful of regulatory reporting requirements across the globe, assuring that cases that meet expedited reporting criteria are forwarded to the Authorities punctually. We thoroughly and accurately describe each event and assign the most accurate Medical Dictionary for Regulatory Activities (MedDRA) or World Health Organization (WHO) drug coding. Throughout this process, our team continually examines the data for evidence of causality. The data is further reviewed by our independent quality control team to ensure that all reporters provide sufficient and accurate study data. This consistent safety data review cycle brings best-in-class safety solutions and patient protection to all of your clinical research projects. At PRA, we chase the case until we have all the required facts.

03
Safety Monitoring

Be Committed. Solutions_Safety_Risk_Management_Safety_Monitoring_Graphic Protection of patients’ safety is of utmost importance to all parties involved in clinical development and marketing of medicinal products. This goal can only be achieved through review of available data at various levels, which requires well planned data exchange and clearly defined responsibilities. We are committed to protect subjects participating in clinical studies. At PRA, we assign a Medical Director with specific expertise in the concerned therapeutic area to each project. They review safety data on an ongoing basis to identify risks for individual patients at an early stage. In addition, PRA offers trend analysis through signal detection and management, and strengthened safety monitoring through our support of Data Monitoring Committees and Central Adjudication Committees. The expertise of our cross-functional teams and their commitment to excellence guarantee the best possible solutions to protect patients’ safety throughout your product’s lifecycle.

04
Safety Profiling

Be Informed. Solutions_Safety_Risk_Management_Safety_Profiling_Signal_Management_Graphic Safety Profiling is the most effective approach to product safety review. It is important to gain an understanding of product safety concerns such as identified and potential risks and missing information, early in product development and share the information with all stakeholders. At PRA, our approach to Safety Profiling includes:
  • An ongoing review and analysis of incoming safety information from various sources
  • Development of a product-specific signal detection strategy, which is the basis for a signal management process.
  • Strategy and processes dynamically designed so that they can be easily modified with improved knowledge of the product’s safety profile.
  • Regularly conducting a signal-to-risk translation for each validated signal.
  • Repeating the benefit-risk assessment using the newly gained knowledge.
Our medical and safety experts ensure that the execution of our well designed processes permit continuous monitoring and early identification of potential safety concerns. The safety profile is used to design an effective benefit risk management plan.

05
Periodic Safety Reporting

Be Compliant. To remain in compliance with the ever-changing regulatory environment, sponsors must file comprehensive aggregate safety reports in a timely fashion. At PRA, we understand the growing expectations of the health authorities and regulatory bodies. Our Safety Teams have been provided extensive training and detailed guidance in the compilation of Development Safety Update Reports (DSURs) and Periodic Benefit Risk Evaluation Reports (PBRERs). The thorough approach we take withstands the scrutiny of regulators regardless of the complexity of your data. We employ processes that assure a quick and meticulous assembly and an on-time delivery. Each report summarizes relevant safety information, assesses safety scientifically, and evaluates benefit-and risk in an integrated approach. PRA also offers an integrated service package including signal detection, benefit-risk evaluation and report writing, or individual pharmacovigilance services customized to your needs.
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06
Benefit Risk Management

Be Prepared. Benefit risk management is mandated by current regulations. As existing regulations are updated and new regulations emerge in all regions, especially in the European Union and United States, the requirements placed on drug development and Marketing Authorization Holders for safety and benefit-risk assessment are steadily increasing. This has led to a significant increase in suitable resource needs. In addition to more astute, efficient and targeted data collection and analysis that is required, it has become more critical to ensure meaningful and accurate iterative benefit-risk management. PRA keeps abreast of regulations and emerging trends and understands current regulatory landscape and industry resource needs for iterative benefit risk management. To ensure continued regulatory compliance, PRA has operationalized current regulations, creating effective benefit-risk management teams. We leverage medical and scientific expertise from across our global teams including Safety and Post-Marketing experts, as well as our Clinical Informatics, Regulatory, Submissions and Publishing groups. PRA’s Benefit-Risk Management Services encapsulate strategy and implementation planning, coordination and execution of target Risk Management Plans (RMP)/Risk Evaluation and Mitigation Strategies (REMS), Risk Minimization Measures (RMM) and effectiveness evaluation of RMMs, and additional pharmacovigilance activities, such as Post-Authorization Safety Studies. Skilled project management and strict attention to quality control assure continued high quality delivery and regulatory compliance. Solutions_Safety_Risk_Management_Benefit_Risk_Management_Graphic