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Pharmacovigilance / Product Lifecycle Management

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Chiltern International Ltd

Covigilant LLC

Factory CRO

Greenleaf Health Inc

KAI Research

Mapi Group

Nutrasource

PAREXEL International Corporation

Pharmaceutical Product Development, LLC

TFS International AB

TransPerfect

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Pharmacovigilance & Safety Reporting

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- Service Details

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.

- Directory Listing

Pharma Service: Clinical Trials

Category: Post Marketing

Sub Category: Pharmacovigilance / Product Lifecycle Management

Periodic Benefit-Risk Evaluation Reports (PBR...

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- Service Details

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

- Directory Listing

Pharma Service: Clinical Trials

Category: Post Marketing

Sub Category: Pharmacovigilance / Product Lifecycle Management

Development Safety Update Reports (DSUR)

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- Service Details

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

- Directory Listing

Pharma Service: Clinical Trials

Category: Post Marketing

Sub Category: Pharmacovigilance / Product Lifecycle Management

Global Post-Approval Services

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- Service Details

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.

- Directory Listing

Pharma Service: Clinical Trials

Category: Post Marketing

Sub Category: Pharmacovigilance / Product Lifecycle Management

Late Phase Partnerships

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- Service Details

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.

- Directory Listing

Pharma Service: Clinical Trials

Category: Post Marketing

Sub Category: Pharmacovigilance / Product Lifecycle Management

Postmarketing Surveillance (PMS)

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- Service Details

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.

- Directory Listing

Pharma Service: Clinical Trials

Category: Post Marketing

Sub Category: Pharmacovigilance / Product Lifecycle Management

Epidemiology

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- Service Details

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.

- Directory Listing

Pharma Service: Clinical Trials

Category: Post Marketing

Sub Category: Pharmacovigilance / Product Lifecycle Management

Pharmacovigilance & Risk Management

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- Service Details

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

- Directory Listing

Pharma Service: Clinical Trials

Category: Post Marketing

Sub Category: Pharmacovigilance / Product Lifecycle Management

SAE / AE Reporting

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- Service Details

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

- Directory Listing

Pharma Service: Clinical Trials

Category: Post Marketing

Sub Category: Pharmacovigilance / Product Lifecycle Management

Product Lifecycle Management

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- Service Details

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.

- Directory Listing

Pharma Service: Clinical Trials

Category: Post Marketing

Sub Category: Pharmacovigilance / Product Lifecycle Management

Pharmacovigilance

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- Service Details

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

- Directory Listing

Pharma Service: Clinical Trials

Category: Post Marketing

Sub Category: Pharmacovigilance / Product Lifecycle Management

Safety & Pharmacovigilance

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- Service Details

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

- Directory Listing

Pharma Service: Clinical Trials

Category: Post Marketing

Sub Category: Pharmacovigilance / Product Lifecycle Management

End-of-Trial Declarations

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- Service Details

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

- Directory Listing

Pharma Service: Clinical Trials

Category: Post Marketing

Sub Category: Pharmacovigilance / Product Lifecycle Management

Pharmacovigilance Services

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- Service Details

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.

- Directory Listing

Pharma Service: Clinical Trials

Category: Post Marketing

Sub Category: Pharmacovigilance / Product Lifecycle Management

Drug Safety Services

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- Service Details

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.

- Directory Listing

Pharma Service: Clinical Trials

Category: Post Marketing

Sub Category: Pharmacovigilance / Product Lifecycle Management

Risk Management & REMS Strategies

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- Service Details

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.

- Directory Listing

Pharma Service: Clinical Trials

Category: Post Marketing

Sub Category: Pharmacovigilance / Product Lifecycle Management

Safety Surveillance & Predictive Signal Detec...

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- Service Details

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

- Directory Listing

Pharma Service: Clinical Trials

Category: Post Marketing

Sub Category: Pharmacovigilance / Product Lifecycle Management

Medical Affairs & Pharmacovigilance

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- Service Details

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.

- Directory Listing

Pharma Service: Clinical Trials

Category: Post Marketing

Sub Category: Pharmacovigilance / Product Lifecycle Management

Safety Surveillance / Observational Programs

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- Service Details

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

- Directory Listing

Pharma Service: Clinical Trials

Category: Post Marketing

Sub Category: Pharmacovigilance / Product Lifecycle Management

Pharmacovigilance & Drug Safety

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- Service Details

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.

- Directory Listing

Pharma Service: Clinical Trials

Category: Post Marketing

Sub Category: Pharmacovigilance / Product Lifecycle Management

Pharmaceutical Risk Management

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- Service Details

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

- Directory Listing

Pharma Service: Clinical Trials

Category: Post Marketing

Sub Category: Pharmacovigilance / Product Lifecycle Management

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