CASE 01
Emergency CDISC Study Rescue
From vendor underdelivery to a submission-ready SDTM / ADaM / define.xml package in approximately three months.
Case Overview
Why this case mattered
A late-stage biometrics rescue in which TUNECT joined after the incumbent vendor stopped meeting the agreed schedule. The challenge was not simply to program faster, but to recover delivery while preserving traceability, submission readiness and controlled statistical decision-making.
~3 months
to finalize SDTM, ADaM and define.xml after handover
On time
submission support delivered under compressed timelines
Follow-on work
collaboration continued beyond the initial study
The Challenge
What TUNECT walked into
The project entered TUNECT's scope only months before the planned submission. SDTM, ADaM and define.xml still required completion, while the existing SAP was too high-level for direct programming. Statistical ownership was split, and unresolved operational questions could easily have become a sequential bottleneck.
Our Approach
How the project was handled
01
Rapid due diligence
Reviewed available study materials, SAP and TFL shells at entry; separated reusable work from elements that needed rework.
02
Parallel workstreams
Started CRF annotation and SDTM immediately, while Data Management clarifications and statistical assumptions were resolved in parallel.
03
Milestone governance
Established a weekly delivery cadence, tracked decisions and milestones, and supported reviewer-guide documentation.
Key rescue principle: do not wait for every ambiguity to disappear before execution. Convert uncertainty into explicit assumptions, owners and decisions while parallel work continues.
Outcome
What changed
Schedule recovery
Programming continued while ambiguities were operationalized through controlled statistician alignment rather than waiting for a perfect SAP.
Submission readiness
The team supported SDTM, ADaM, define.xml and associated reviewer-guide activities under the compressed schedule.
Relationship expansion
Successful delivery converted a rescue assignment into broader follow-on collaboration.