Project Description

The challenge

A top-5 pharmaceutical company required ad hoc medical writing support during times of high workload.

They needed several types of documents written, including:

  • Clinical study reports.

  • Narratives.

  • Disclosure documents.

  • Annual IND/NDA/DSUR reports.

  • IB and IMPD updates.

  • Clinical overviews and summaries.

Our approach

We established a consistent senior resource for our client in a Project Lead and Senior Medical Writer. They are responsible for:

  • Project managing and authoring various documents.
  • Accessing the company repositories and templates via client laptop.
  • Coordinating with other strategic partners who perform QC, compliance checks and publishing.

The result

The client has a remained a long-term partner since September 2007. Since then, we have:

  • Completed various documents.
  • Established consistent flexible support that is familiar with the client’s processes and systems.
  • Saved the client money thanks to the cost effectiveness of a blended local-remote delivery model.
  • Managed shifting priorities seamlessly thanks to the scalability of our established model.

In future, senior medical writers may be embedded into the study team allowing client resource to focus on critical activities.

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