Agility and a collaborative spirit delivers when plans changed
We supported a major pharma client with a new indication for an antiplatelet drug, including a 13,000-patient cardiovascular outcome trial CTD submission. We took over the CSR from another CRO and delivered the CTD Module 2.7.4 and RMP.
the challenge
The goals were to rapidly turn around the quality of the CSR and to resolve differing opinions on the CTD’s safety content among the client’s experts.
our approach
We assigned a senior medical writer with knowledge of the drug and disease who had supported a previous submission for this drug. She consulted with the client about the CSR issues, then rewrote the CSR Prototype by liaising with experts to prioritize the large number of statistical outputs of key study endpoints, facilitating a structured debate between experts to resolve conflict and get agreement on data presentation, interpretation, and messaging, using lean authoring and mapping connections between Module 2.7.4 and the CSR to maximize cross-linking, enforcing the use of conventions, and motivating the team to remain focused after a disappointing study outcome.
the results
The draft CSR was delivered 6 days after interpretation, beating the planned 12 days, to expedite senior decision-making. The final CSR and RMP were delivered to quality and plan. The study did not meet its primary objective and the CTD was not submitted to a health authority.
our value
Agile responsiveness and learning from previous successes and failures delivered quality work in a short time. Prior experience with the drug accelerated the project, and previous close collaboration with the client’s team enhanced overall efficiency. We also shared our learnings with the authoring team for the drug’s next CTD submission.
“I’ve never been part of a team where the collaboration between internal and external members was so strong.”