Project Description

The challenge

The client needed medical writers who could embed into their existing study teams to coordinate and author high quality documents on time and within budget.

Kinapse was selected as one of three preferred providers to manage, author and QC clinical study reports (CSRs), safety narratives, basic results (BRs) and website synopsis.

Our approach

The program was managed by senior level members, who established a team built from:

·       Experienced local ‘lead medical writers’ to guarantee high quality and consistency within documents.

·       A blend of local and remote employees for authoring and QC. The BR workstream was transferred to a remote team within 6 months of the project start.

·       A mixture of a dedicated team and flexible support, enabling large volume of documents to be generated.

The result

The client has remained a long-term partner since July 2010, and has seen ongoing results from this project. So far we have:

  • Completed more than:
    • 130 CSRs.
    • 2500 narratives.
    • 500 BRs.
    • 100 disclosure summaries.
  • Delivered consistent and measurable quality that has exceeded expectations.
  • Created dedicated resources ensuring the knowledge of processes and systems we build is maintained and shared.
  • Freed up previously strained client resources to focus on critical activities by embedding local medical writers into the study team.
  • 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.

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