Covigilant LLC

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PERIODIC BENEFIT-RISK EVALUATION REPORTS (PBRER)

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

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Pharma Service: Clinical Trials

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Sub Category: Pharmacovigilance / Product Lifecycle Management

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TransPerfect

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PHARMACOVIGILANCE & SAFETY REPORTING

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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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Pharma Service: Clinical Trials

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Factory CRO

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POSTMARKETING SURVEILLANCE (PMS)

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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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Pharma Service: Clinical Trials

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GLOBAL POST-APPROVAL SERVICES

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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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Pharma Service: Clinical Trials

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Covigilant LLC

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DEVELOPMENT SAFETY UPDATE REPORTS (DSUR)

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

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Pharma Service: Clinical Trials

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PAREXEL International Corporation

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LATE PHASE PARTNERSHIPS

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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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Pharma Service: Clinical Trials

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PAREXEL International Corporation

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EPIDEMIOLOGY

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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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Pharma Service: Clinical Trials

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Sub Category: Pharmacovigilance / Product Lifecycle Management

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Icon Plc

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PHARMACOVIGILANCE & RISK MANAGEMENT

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

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Pharma Service: Clinical Trials

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Sub Category: Pharmacovigilance / Product Lifecycle Management

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Factory CRO

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SAE / AE REPORTING

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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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Chiltern International Ltd

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PHARMACOVIGILANCE

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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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Greenleaf Health Inc

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PRODUCT LIFECYCLE MANAGEMENT

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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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Pharma Service: Clinical Trials

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KAI Research

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SAFETY & PHARMACOVIGILANCE

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

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TFS International AB

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END-OF-TRIAL DECLARATIONS

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The TFS Regulatory Affairs Unit offers operational and strategic consulting services and has extensive experience in managing all aspects of regulatory affairs, supporting a product from the drug development phase throughout all phases of clinical development to market authorization and product

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PHARMACOVIGILANCE SERVICES

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Our experienced team of more than 700 pharmacovigilance professionals worldwide provide 24/7/365 availability and is fully focused on identifying and applying valuable insights based on pharmacovigilance needs.

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PAREXEL International Corporation

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DRUG SAFETY SERVICES

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PAREXEL understands that patient safety is at the heart of every company’s focus. This is why we are committed to delivering quality, integrated drug safety services across the full spectrum of the post-approval life cycle.

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Pharma Service: Clinical Trials

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RISK MANAGEMENT & REMS STRATEGIES

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Our risk management team works in a matrix approach with departments across PPD. Experts in epidemiology, registries and observational studies, regulatory affairs, pharmacovigilance and call center operations provide support to REMS programs.

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Pharma Service: Clinical Trials

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Chiltern International Ltd

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SAFETY SURVEILLANCE & PREDICTIVE SIGNAL DETECTION

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Chiltern’s industry-leading team of data management professionals and statisticians is one of the largest in the industry. With real-world experience in adaptive trial designs and the latest data analytics platforms and technologies, we make certain you can not only access, but also examine

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Nutrasource

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MEDICAL AFFAIRS & PHARMACOVIGILANCE

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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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Pharma Service: Clinical Trials

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TFS International AB

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PHARMACOVIGILANCE & DRUG SAFETY

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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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Pharma Service: Clinical Trials

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Chiltern International Ltd

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SAFETY SURVEILLANCE / OBSERVATIONAL PROGRAMS

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Over the last three decades, our medical device study team has successfully managed hundreds of studies for all classes of medical products.

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Pharma Service: Clinical Trials

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PAREXEL International Corporation

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PHARMACEUTICAL RISK MANAGEMENT

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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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Prorelix Research

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PHARMACOVIGILANCE SERVICES

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ProRelix Research offers end to end pharmacovigilance services such as individual case safety reports writing, narrative writing, SAE reports, triage, medical review, signal detection, risk management and report submission to the regulators.

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ICBio Clinical Research Pvt Ltd

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SAFETY REPORTING & PHARMACOVIGILANCE SERVICES

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We, at ICBio, offer complete Pharmacovigilance Services, which include data collection, processing, medical review, safety writing, report writing, reporting, signal detection and analysis.

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Pharma Service: Clinical Trials

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Sub Category: Pharmacovigilance / Product Lifecycle Management

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