CASE 02
Scaling CDISC Delivery for an FDA-Facing Program
High-volume laboratory data, aggressive timelines and embedded FSP delivery across a growing program.
Case Overview
Why this case mattered
A partner referral developed into a multi-study FSP engagement. The program combined large laboratory-data volumes with aggressive submission timelines, making standardization and repeatable QC more important than simply adding programming capacity.
On time
initial project delivery under regulatory-facing deadlines
3 studies
collaboration expanded across a wider program
~90% pre-DBL
datasets and TFLs programmed and validated in a subsequent study
The Challenge
What TUNECT walked into
The CRO's existing technology partner identified substantial delivery risk, particularly around the volume and complexity of laboratory data. TUNECT needed to operate as part of the CRO team, align quickly with existing standards and build a workflow that could scale across multiple studies.
Our Approach
How the project was handled
01
Feasibility + scoping
Assessed laboratory-data complexity, transformation rules and reporting expectations before scaling the team.
02
Standardized build + validation
Applied repeatable programming and QC routines across SDTM, ADaM and reporting outputs to protect consistency.
03
Reporting readiness
Built re-runnable TFL pipelines and prepared reporting structures early so post-DBL work focused on finalization rather than reconstruction.
The delivery model was built around one principle: standardize first, then scale. Reusable programming and validation routines reduced both operational variability and late-stage risk.
Outcome
What changed
Predictable delivery
The initial project was completed on schedule despite the high-volume data environment.
Program scalability
The operating model was reused as the collaboration expanded across additional studies.
Reduced post-DBL pressure
In a later study, most datasets and TFLs were already programmed and validated before database lock.
Client, Sponsor and study identifiers are anonymized where needed.
Facing a similar challenge?
TUNECT can join as a project team, embedded FSP resource or independent specialist group depending on the study need.