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Safety & Pharmacovigilance

Clinical Trials >> Post Marketing >> Pharmacovigilance / Product Lifecycle Management

Our team of Drug Safety Associates (DSAs) provides clinical safety and pharmacovigilance support for biopharmaceuticals throughout the product life cycle.

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Pharmaceutical Risk Management

Clinical Trials >> Post Marketing >> Pharmacovigilance / Product Lifecycle Management

PAREXEL's Pharmacovigilance services includes a wealth of experts in the field of Risk Management planning and strategy, many with FDA and MHRA backgrounds.

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Pharmacovigilance & Drug Safety

Clinical Trials >> Post Marketing >> Pharmacovigilance / Product Lifecycle Management

The Drug Safety Unit has extensive experience in managing all aspects of drug safety/pharmacovigilance services, from the drug development phase through to market authorization surveillance and the set-up of a pharmacovigilance system.

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Periodic Benefit-Risk Evaluation Reports (PBRER)

Clinical Trials >> Post Marketing >> Pharmacovigilance / Product Lifecycle Management

Based on our extensive pharmacovigilance operations experience, we customize database software query tools to expand your data mining capabilities.

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Pharmacovigilance & Safety Reporting

Clinical Trials >> Post Marketing >> Pharmacovigilance / Product Lifecycle Management

We enable global clinical development teams to rapidly translate and share pharmacovigilance information, such as SUSARs (suspected unexpected serious adverse reactions), SAEs (serious adverse events), hospitalization reports, and discharge summaries, within a centralized collaborative workspace.

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Epidemiology

Clinical Trials >> Post Marketing >> Pharmacovigilance / Product Lifecycle Management

At PAREXEL® we have senior Epidemiologists, and Statisticians, who have many years experience within the pharmaceutical industry providing solutions to the questions faced by our clients.

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Pharmacovigilance

Clinical Trials >> Post Marketing >> Pharmacovigilance / Product Lifecycle Management

Our global Pharmacovigilance teams have the knowledge of local regulations, standards of care and cultural customs you need to identify and assess risks during your clinical trial — keeping patient safety a top priority. And, we have locations around the world to accommodate your trials wherever

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Late Phase Partnerships

Clinical Trials >> Post Marketing >> Pharmacovigilance / Product Lifecycle Management

PAREXEL's Peri/Post-Approval Services group of experts are dedicated to late phase research, offering a proven partnership model designed specifically for Late Phase.

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Product Lifecycle Management

Clinical Trials >> Post Marketing >> Pharmacovigilance / Product Lifecycle Management

Greenleaf Health Inc. offers various services such as: Strategic guidance on FDA’s regulatory process; All aspects of product development; Premarket review; Postmarket safety requirements; Analysis of the market to identify potential competition.

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Medical Affairs & Pharmacovigilance

Clinical Trials >> Post Marketing >> Pharmacovigilance / Product Lifecycle Management

As part of our mission of ensuring sound scientific evidence in support of safe and effective products, our team places emphasis on product safety. We offer our clients a flexible suite of pharmacovigilance services during product development.

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