CSR · DSUR · ISS/ISE
Reports that match the data.
Clinical study reporting is where programming and medical writing should meet. We produce the in-text tables, listings, figures and CSR modules that keep the narrative honest, and we stay through agency questions.
Who it's for
The brief we take.
Medical writers, clinical scientists, and biometrics heads who need a programming partner that understands ICH E3 structure, not only PROC REPORT.
Deliverables
What leaves the studio.
- CSR in-text tables and appendix TLFs
- DSUR, PSUR and development safety update support
- ISS/ISE pooling specifications and outputs
- Patient narratives data packages
- QC of medical-writing tables against ADaM
- Response-to-questions programming after submission
Tools & standards
The stack, without the logo wall.
Engagement
How you hire us.
- Locked-database sprint to CSR
- Retainer through submission and questions
- ISS/ISE pooling as a standalone workstream
Anonymized: CSR appendix package for a vaccine study, 180 outputs, handed to medical writing three days after database lock.
FAQ
Before the call.
Do you write the CSR narrative?
We do not replace medical writing. We deliver the numbers, shells, and in-text tables they write from — and we check that the draft still matches the data.
Can you support an ISS/ISE?
Yes. Pooling strategy, ADaM integration, and the display package. We flag integration issues early rather than at lock.
Also in the studio
Statistical Programming
Submission-ready analysis datasets and TLFs, programmed once and QC'd twice.
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.