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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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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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Postmarketing Surveillance (PMS)

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

Factory has expertise in the design, conduct, analysis and reporting of PMS studies. Results from well-designed PMS studies can strengthen your marketing and sales efforts.

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Development Safety Update Reports (DSUR)

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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Global Post-Approval Services

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

Our clinical experience in product development ensures collaboration and integration from pre-approval to post-approval. We provide a custom-tailored process, fine-tuned across the globe, to meet local regulatory requirements.

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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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Pharmacovigilance & Risk Management

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

Mapi provides a flexible, global pharmacovigilance service supporting regulatory compliance and management of patient safety issues.

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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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SAE / AE Reporting

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

Our MDs are experts in the safety evaluation and handling of Serious Adverse Events that are reported during the trial follow up period.

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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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