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Our client received a boxed warning from the FDA which required them to implement a Risk Evaluation Mitigation Strategy (REMS) with an associated questionnaire. The product in question had been marketed in the US for more than 25 years.

Subsequently, a class action lawsuit was brought against the client related to the product. As a result of this, the client began receiving large volumes of individual case data and multiple medical records, typically 500 pages or more in length. Due to the increased number and complexity of case documents, the client’s internal resources and expertise were insufficient to meet regulatory reporting requirements.

The client also required assistance in managing the REMS and legal documents, including short-form complaints, long-form complaints, plaintiff fact sheets, medical and/or pharmacy records, and transcribed depositions.

Ashfield Pharmacovigilance’s flexible work model provided adequate resources to quickly establish a team to focus on the large influx of case documents. A job aid and an adverse event expectedness list were developed to ensure consistency in case management, and to ensure that all cases were handled expeditiously, Ashfield Pharmacovigilance established bi-weekly source document reconciliation of electronic and paper files.

Ashfield Pharmacovigilance also assisted the client in developing and implementing a patient-focused questionnaire, as required by the REMS, as well as taking responsibility for drafting, transmitting, and sending all Other Company Letters to outside pharmaceutical companies with and without Safety Data Exchange Agreements (SDEAs).

Ashfield Pharmacovigilance quickly established a comprehensive pharmacovigilance solution to relieve client stress related to the unexpected increase in volume and complexity of incoming safety data.

Over 6,200 serious and non-serious individual case reports were processed, results from all focused questionnaires were managed, and all follow up information was processed.

The client submitted a proposed modification to the REMS that met regulatory demands and associated timelines and was able to focus internal resources on responding to prolonged and complicated litigation requirements knowing that Ashfield Pharmacovigilance would meet all regulatory pharmacovigilance requirements.

Reflecting our values:
Ashfield Pharmacovigilance was able to collaborate with the client to establish a solid, quality partnership that permitted the staff to work efficiently, producing high-quality reports for delivery to regulatory agencies and meeting strict timelines.


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