SAS · R · CDISC
Analysis datasets that survive review.
We program ADaM, produce Tables, Listings and Figures, and stand behind the traceability from raw to CSR. Sponsors get a named programmer, a second-programmer QC, and a package that does not unravel in agency questions.
Who it's for
The brief we take.
Biostatistics leads, statistical programming managers, and clinical operations teams at pharma and biotech who need surge capacity or a specialist ADaM/TLF studio.
Deliverables
What leaves the studio.
- ADaM datasets and specifications aligned to CDISC and the SAP
- Tables, Listings and Figures for DSUR, CSR, and ISS/ISE
- Define-XML, ADRG, and reviewer guides
- Reproducible SAS and R programs with independent QC
- Randomization schedules and sample-size support with the statistician
- Interim analysis programming under unblinding firewalls
Tools & standards
The stack, without the logo wall.
Engagement
How you hire us.
- Study-based project (protocol to CSR)
- Named FTE embedded with your programming lead
- On-demand sprints for a TLF wave or a rescue
Anonymized: a Phase III oncology TLF package of 400+ outputs, ADaM conversion included, delivered in eight weeks with zero critical findings at sponsor QC.
FAQ
Before the call.
Do you work from our SAP and shells, or write them?
Both. We program to an existing SAP and TLF shells, or we sit with your statistician to draft shells that a programmer can actually build.
SAS or R?
Whichever the submission expects. Most sponsors still want SAS for ADaM and TLFs; R is used for graphics, simulation, and RWE. We keep the audit trail in either language.
How is QC structured?
Independent second programmer, double programming on primary endpoints and critical safety, log review, and a findings tracker you can see.
Also in the studio
Clinical Study Reporting
CSR sections, appendices and in-text tables written to the numbers — not around them.
Data Management
Clean, lockable clinical databases with CDASH-minded eCRFs and a query process that does not stall sites.
Real World Evidence
Study design, programming and analysis of real-world data that a medical affairs or HEOR team can defend.
Tell us what is on the clock.
A scoping call is thirty minutes. Bring a protocol, a TLF list, or a model that needs hands.