Clinhelix helps clinical programming teams build the aCRF, SDTM, ADaM, TLFs, reviewer's guides and CSR content, with every output traceable to its source.
Most tools automate a single deliverable. Clinhelix carries a study from CRF to clinical study report, so decisions made upstream flow into every output after them.
Generate annotated CRFs mapped to SDTM domains and variables, straight from your CRF design.
Turn raw datasets into SDTM with reviewable mapping specifications and generated programs.
Derive analysis datasets with documented derivations that stay linked to their sources.
Produce tables, listings and figures from ADaM, following your shells and statistical analysis plan.
Draft the csDRG and ADRG alongside the data, so documentation never trails the datasets.
Review and triage P21 validation findings, with each issue traced back to the code behind it.
Draft clinical study report sections from your TLFs, ready for medical writers to refine.
Assemble datasets, programs and documents into a submission-ready package.
Every variable, table and statement links back to the data and specification it came from.
AI drafts the work. Your team reviews, edits and approves every output before it moves on.
SDTM, ADaM and validation checks are part of the workflow, not an afterthought.
Tell us about your study and we will walk through the workflow with you.