Pharmacovigilance & Patient Safety

We provide a comprehensive range of drug safety services, minimizing risk and protecting patient well-being from clinical development to post-marketing.

PRA PVS End to End Services

PRA Pharmacovigilance & Patient Safety Global Distribution

PERSONNEL

800

Pharmacovigilance & Patient Safety Professionals

DRUG SAFETY CENTERS (DSC)

19

COUNTRIES

80+

In our central repository of regulatory reporting requirements

We provide safety regulatory intelligence services, which removes the complexity of navigating requirements across the pharmacovigilance landscape. Our global team supports our clients with a key quality management system component of knowledge management within safety. Through the collection, assessment and critical analysis of safety intelligence, we are able to support your oversight of global compliance activities and adherence to global and local legislation. Our bespoke service is tailored around your needs, to aid timely and strategic decision making through the development and approval of your product.

Services are provided via centralized Drug Safety Centers located throughout Europe, Asia, and the Americas (see map above), by regionally-based remote staff, or through Embedded™ resources working in a seamless fashion at client sites. The global team works cross-functionally with other service areas such as Real World Solutions and Therapeutic Expertise to help our clients effectively manage their drug safety information.

Safety data is processed in our Argus safety database, analyzed and critical safety information can be securely shared with regulatory authorities and other stakeholders via gateway (E2B (R3)) or other methods. For projects where the PRA Argus safety database isn’t utilized, our resources work directly in the clients’ systems. Our electronic tracking system provides transparency of our compliance with global regulations during audits and inspections.

Technology

PRA’s dedicated PVS systems and tools are supported by a fully dedicated PVS Systems Team.

PRA utilizes the following systems:

Argus (E2B R3)
PsiXchange
Axway
Safety Letter Tracking System (SLTS)
Quality Tracking Online (QUATRO)
DistillerSR (Literature Search Tool)

EndPoint Adjudication Tool
Safety Case Tracker (SCT)
Argus Reporting Tool (ARETO)
Orbit™ (Risk/Signal/Aggregate Tracking)
Spotfire® (Signal Detection)
Risk Impact Assessment Documentation (RIAD)

Safety Surveillance & Signal Detection

Our approach to safety surveillance and signal detection enables us to identify potential safety concerns early and ensure compliance with today’s ever-changing regulatory environment.

Well-planned data exchange and clearly defined responsibilities are essential in the development and marketing of safe medicines.

The PRA safety surveillance team performs analysis of signals or trends that may be evident in a dataset as well as monitoring and review of any adverse events of special interest. PRA can generate meaningful outputs and visualizations using Spotfire® to facilitate the review of safety data and identification of safety signals.

Where signal validation and assessment are required, PRA can support review of prior awareness, strength of the evidence, analysis of sub-population at higher risk and clinical relevance of the signal. If need be, PRA can assess other relevant data sources such as regulatory databases, claims databases or scientific literature.

Prioritization is assessed throughout the whole process by evaluating the impact on the benefit-risk balance of the product ensuring the timely disposition of safety concerns.

Signal Management Process

Signal Detection

Signal Validation

Signal Assessment

Action Plan

Communication

Our Safety Teams have extensive experience in the generation of aggregate safety reports, such as DSURs, IND Annual Reports, PBRERs, and PADERs. They understand the expectations of health authorities. Each report summarizes relevant safety information, assesses the information scientifically, and evaluates benefits and risks in an integrated approach.

We track all steps of aggregate safety reports through planning, generation, and reporting via our Orbit system for compliance with regulatory requirements, full transparency and inspection readiness.

Our PVS experts perform literature surveillance to help monitor products’ benefit-risk ratio throughout their lifecycle. We develop strategies to screen scientific literature from large databases, such as Medline and Embase. With our standalone literature tool DistillerSR, we identify and analyze scientific articles to detect adverse reactions and safety signals. We also conduct literature surveillance to support generation of aggregate safety reports, risk management plans, or meta-analysis.

Safety Reporting

A Safety Scientist is assigned to your program to plan and coordinate the entire process of Aggregate Safety Reports and assume responsibility for quality control.

A Medical Director is responsible for the benefit-risk evaluation, as well as the clarity, accuracy, consistency, completeness, and correctness of the Aggregate Safety Report.

A Safety Expert is available to consult the Medical Director, the PRA team and our client in case potential safety concerns are identified during the creation of the Aggregate Safety Report.

A Safety Writer writes aggregate safety reports under the supervision of the Medical Director.

A PV Systems Manager imports and exports data to and from the safety database and provides the required listings from the safety database.

A Drug Safety Associate processes the safety information in the safety database and also performs expedited and periodic safety reporting.

Risk Management

PRA recognizes that risk management in support of a medicinal product (drug, biologic, vaccine) is applicable at any stage of development and is often a significant component of the product’s life cycle.

PRA’s Risk Management Team is an integrated global team with substantial experience identifying innovative solutions to satisfy regulatory requirements and providing fit-for-purpose strategies to meet client needs for risk management. Our risk management approach begins at proof-of-concept and early development and continues throughout the lifecycle of the medicinal product. PRA’s strategy when designing a product-specific risk management system is to characterize and minimize risks to patient safety. Using lessons learned and strategies acquired through decades of experience, our team of risk management experts collaborate with clients to identify the critical regulatory requirements for successful risk management planning and execution.