Case Study

Helping the client to deliver 6 CSRs for one clinical programme simultaneously to aggressive timelines

Regulatory Writing

Challenge

To deliver 6 CSRs and associated narratives concurrently to tight timelines working collaboratively with a cross-functional team, across different time zones

Effective management by a single point of contact at Bioscript, overseeing the project with a team of writers
Effective project team meetings enabled buy-in from key stakeholders ensuring alignment on objectives and timelines
Open and transparent communication to ensure team awareness of process, timelines, document review dates, and key decisions
Front-loading CSR prototypes to speed the development of the CSRs when data became available
Robust tracking procedures and persistent follow up ensured that the delivery stayed on track

Brought together several workstreams to deliver high-quality CSRs and narratives within the agreed condensed timelines
Open and transparent communication was key for engagement with the cross-functional team, building strong working relationships
Collaborative and constructive team discussions supported the overall high-level document authoring