Ophthalmology indication (Relatively new for the writer) Phase 2 CSR for authoring
Outputs - 500+ TLFs for authoring and interpreting results (from the usual 100 to 200)
SIRO Solution:
TA orientation and training by MD from Medical Affairs before commencing of authoring
Orientation to the IB helped create better understanding of the molecule and indication
Teleconference/collaborate with different stakeholders from sponsor team to discuss relevant tables which need more emphasis
Review of the first draft by "Review Panel " (a unique SIRO solution – first draft is reviewed by 2 to 3 senior MWs and comments discussed/brainstormed in a meeting room with a larger team to produce a robust first draft)
Key Takeaways:
Sponsor PoC oversight was minimal
Upfront discussion of comments with stakeholders helped a great deal in restricting number of CSR reviews to bare minimum (#2)
Despite an altogether new indication CSR was delivered within the committed timeframe
SIRO was awarded to author similar 2 CSRs of the same molecule
