及时对 EMA 安全性问题做出高质量回应

The eight EMA safety queries were complex and concerned multiple clinical, safety, and regulatory components. With a timeline of only three weeks to review and address these queries, the project required fast and efficient planning and execution.

Generating the required data to respond to the queries took approximately one and a half weeks, consuming half of the available timeline. This left only one and a half weeks for writing, quality control (QC) activities, client review, finalization, and submission.

The complex project and the tight deadline meant over 20 team members were engaged to ensure we met the client’s requirements. Coordinating the efforts of the team across various disciplines and geographies was its own challenge.

We took a highly collaborative and structured approach to meet the tight deadline. Three dedicated safety/aggregate report writers from Certara were assigned to work on the responses in parallel, enabling rapid content development.

To expedite the process further, QC of the writers’ drafts, editorial reviews of client-provided content, and client reviews were conducted on a rolling basis, rather than the traditionally sequential approach.

A lead writer facilitated daily team calls, ensuring that all tasks were on track and that any issues were swiftly resolved.

The team of writers were located in both the UK and US, and the different time zones were leveraged to extend the availability of writer support.

Despite the complexity of the queries and stringent timeline, we were able to work with the client to deliver a comprehensive, high-quality response document to the EMA on time. The client expressed their appreciation and subsequently engaged Certara for additional regulatory and safety support.

Certara’s team of experts is here to support your regulatory and safety challenges, including health authority queries, with precision, speed, and quality.