Delivering adverse event narratives in a short time frame for a global pharma

Case Study

Delivering adverse event narratives 2017-11-06T16:29:15+00:00

Project Description

The challenge

A global Pharma company was preparing to register a drug in the USA that had been available for the last 20 years in Europe.

As part of safety information required by the FDA, the client had to submit narratives of adverse events (AEs) leading to discontinuation from 150 European studies in a tabular format.

The client needed a solution to produce these documents in a stringent time frame. They knew this would be a challenge because the completeness and quality of source data was highly variable.

“We are highly satisfied with our collaboration with Kinapse, and we are pleased for this to continue.”

Our approach

A global Pharma company was preparing to register a drug in the USA that had been available for the last 20 years in Europe.

As part of safety information required by the FDA, the client had to submit narratives of adverse events (AEs) leading to discontinuation from 150 European studies in a tabular format.

The client needed a solution to produce these documents in a stringent time frame. They knew this would be a challenge because the completeness and quality of source data was highly variable.

The offshore team leader ensured consistency across the AEs with a template and rapidly resolved any and all queries.

The result

With our help, the client successfully delivered over 300 tabular AE narratives within 6 days. The client’s feedback was very positive with regards to the high quality, timeliness and flexibility of the service provided.

Further collaboration is planned with the client in the future.

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