Timeline compression, not a head start
Because the shell is built during conduct instead of after lock, CSR full writing starts immediately, one of the biggest levers for cutting time to submission.
What's included
What goes into the shell
- Full ICH E3 section structure drafted and outlined ahead of database lock
- Table, listing, and figure placeholders mapped to the mock TLF shells produced from the SAP
- Standard boilerplate language and methods text drafted early, leaving only results-dependent sections open
- Cross-references between sections checked for consistency before any study data is available
- Shell reviewed against the protocol and SAP so nothing needs restructuring once real numbers arrive
- A locked shell handed to the writing team the day the database locks, ready for full writing
Built on the same numbers as the tables
Shell structure follows the mock TLFs from biostatistics, so when real tables land, they drop into a report structure that already matches them section for section.