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Case Studies.

Pharmacovigilance / USA

Pharmacovigilance preparation for product launch

Insight Our client, a fast growing company, had recently received recommendation for approval by the FDA Advisory Committee and needed to sh ...

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Pharmacovigilance / USA

E-submissions through the FDA portal

Insight The FDA was requiring e-submissions be set up through the FDA portal.  Ashfield Pharmacovigilance determined that this process woul ...

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Pharmacovigilance / USA

Supporting database integration during a corporate merger

Insight Ashfield’s client, “Client A”, a large pharmaceutical company who continues to grow through acquisition, purchased “Client B ...

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Pharmacovigilance / USA

Supporting a wide range of Pharmacovigilance services

Insight In early 2010, Ashfield formed a partnership with a global consumer brands company (consumer care, cosmetics, device, and soap/house ...

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Pharmacovigilance / Multiple Locations

Over a decade of partnership

Insight Ashfield’s partnership with “Client A” began in 2006 with case management for one marketed product and continues today for mul ...

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Pharmacovigilance / USA

Creating a drug safety infrastructure from the ground up

Insight Ashfield Pharmacovigilance was hired to establish a drug safety department for a generic company which had no internal infrastructur ...

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Pharmacovigilance / USA

Effective pharmacovigilance case management

Insight Ashfield Pharmacovigilance was hired to provide case management augmentation to a top ten (10) global pharmaceutical company. The co ...

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Pharmacovigilance / USA

Pharmacovigilance and medical information efficiencies

Insight: Our pharmacovigilance client was looking to change their medical information call center vendor due to pain points relating to pric ...

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Pharmacovigilance / USA

Proactive signal detection

Insight: Ashfield Pharmacovigilance was providing routine pharmacovigilance for a client’s low risk product. This product had no black box ...

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Pharmacovigilance / USA

Due diligence for product acquisition

Insight Our client, a medium sized pharmaceutical company, was seeking acquisition of new products, and reached out to the current Market Au ...

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Pharmacovigilance / USA

Assessing the true value of pharmacovigilance

Insight: Our post market pharmacovigilance (PV) client was planning a clinical trial, which was being executed by a large clinical CRO. Our ...

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Pharmacovigilance / Global

First Outsourcing Experience for a Global Veterinary Pharmaceutical Company

Insight Our client had never outsourced veterinary drug safety case management and preferred to maintain their database in-house. The client ...

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Pharmacovigilance / Global

Management of Case Processing & Reporting

Insight: Our client received a boxed warning from the FDA which required them to implement a Risk Evaluation Mitigation Strategy (REMS) with ...

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Pharmacovigilance / Global

Handling serious adverse events for complex clinical trial

Insight:  Our client, an emerging pharmaceutical company, was conducting large Phase III trials for a last-line therapy to treat a progress ...

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Pharmacovigilance / Global

Rapid response to product recall

Insight: Our client, a global pharmaceutical company with a significant presence in consumer healthcare, had announced a voluntary product r ...

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Pharmacovigilance / Global

High-volume adverse event screening

Insight: Following a regulatory audit, a large pharmaceutical client had 1.2m documents that needed reviewing to identify adverse events. Re ...

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