EDC · CDASH · lock
A database you can lock.
Data management at CodLad is built for the programmers who inherit it. eCRF design, edit checks, medical coding and lock activities are run so that SDTM and ADaM do not become archaeology.
Who it's for
The brief we take.
Clinical data managers and heads of biometrics at emerging biotech who need a senior DM without standing up a department.
Deliverables
What leaves the studio.
- eCRF design against CDASH and the protocol
- Edit-check specifications and UAT
- Query management and site metrics
- MedDRA and WHODrug coding
- Reconciliation of SAE, lab and external data
- Database freeze, lock and post-lock change control
Tools & standards
The stack, without the logo wall.
Engagement
How you hire us.
- Full-study data management
- Lock-readiness rescue
- Coding and SAE reconciliation only
Anonymized: mid-size biotech study taken from messy mid-study eCRF to lock in eleven weeks, with a coding backlog cleared in the first fortnight.
FAQ
Before the call.
Which EDC do you use?
We work inside the system you already run. We are platform-agnostic; the discipline is in the specs, the checks, and the lock checklist.
Do you code in MedDRA?
Yes. Our team holds MedDRA training and codes concomitant medications in WHODrug. Version control is documented for the CSR.
Also in the studio
Statistical Programming
Submission-ready analysis datasets and TLFs, programmed once and QC'd twice.
Clinical Study Reporting
CSR sections, appendices and in-text tables written to the numbers — not around them.
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.