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Biostatistics · Rescue
A stalled Phase III oncology submission, back on timeline in weeks
A mid-size sponsor inherited a delayed biometrics package from a departing vendor eight weeks before a planned submission. K3 assumed scope without resetting the clock.
6 wks
from handover to database-ready outputs
100%
CDISC conformance at first validation
0
timeline slip against the original date
The challenge
The programming team on a pivotal oncology study left mid-deliverable. The sponsor faced a choice between slipping a submission that investors were watching, or handing an incomplete, undocumented codebase to a new vendor and hoping. Neither was acceptable.
What K3 did
- A senior K3 biostatistics lead scoped the inherited package in the first 72 hours, mapping every existing program against the SAP
- Work was rebuilt on SPARC, so ADaM datasets and TLFs regenerated deterministically with full lineage back to the plan
- Double-programming resumed immediately under a firewalled team for the interim analysis
- CDISC conformance was checked continuously against the rule set, rather than in a pre-submission scramble
The outcome
The package reached database-ready state in six weeks, conformant on first validation, and the submission held its original date. The sponsor retained K3 as its FSP biometrics function afterward.