Submission-Ready Tables, Listings, and Figures from CDISC ADaM
Trialhelix generates TLF outputs from validated ADaM datasets — in SAS, R, and RTF formats — linked to your Statistical Analysis Plan for DSMB reviews, interim analyses, and IND/NDA packages.
Reporting Features
Standard Safety Tables
AE summary by SOC and PT, TEAE frequency and severity, SAE listings, dose modification tables — generated from ADAE and ADCM ADaM datasets. MedDRA dictionary version and data cut date stamped on every output.
PK/PD Summary Figures
Mean concentration-time profiles, individual PK listings, NCA summary statistics. Generated from ADPC and ADPP ADaM datasets. Output in SAS graphic format and as publication-quality PDF for IND documents.
Patient Data Listings
Full subject disposition listings, protocol deviation listings, and individual subject data narratives. Generated directly from SDTM/ADaM datasets — no manual population of listing templates.
Multiple Output Formats
SAS PROC REPORT, R knitr, and RTF output formats. Table shells can be defined from SAP specifications and pre-validated before the data cut — reducing time from database lock to TLF delivery.
SAP Linkage
TLF shells are linked to Statistical Analysis Plan sections. When the SAP is amended, the linked TLF specifications flag which outputs require review. Sponsor biostatisticians can review TLF shells before data lock without seeing unblinded data.
Regulatory Package Generation
Integrated generation of clinical study report appendices: TLF volume, SDTM dataset package, ADaM dataset package, and define.xml. Structured for eCTD Section 5.3.5 organization.
Submission Validation Before Data Lock
Pinnacle 21 validation is the industry standard for CDISC conformance checking before FDA submission. Trialhelix runs validation continuously — so you arrive at data lock with a clean report, not a new list of issues to fix.
Continuous Validation Runs
P21 validation runs automatically when SDTM or ADaM domains are updated. The CDM lead sees a validation summary on the study dashboard without navigating to a separate tool.
Suppression Tracking
P21 rule suppressions (justified deviations) are tracked with the CDM who approved them, the reason, and the date. Suppression history is part of the study audit trail — not stored only in the validation tool.
Reviewer's Guide Generation
The Reviewer's Guide for each SDTM and ADaM dataset is auto-generated from domain metadata — variable labels, derivation algorithms, and dataset population criteria — in format consistent with FDA technical specifications.
define.xml Generation
define.xml is generated from the SDTM and ADaM metadata maintained during data collection — it is not a manual post-lock document. The define.xml links variables, codelists, and analysis datasets as required for CDISC-eCTD submissions.
See TLF Output for Your Study Design
Bring your SAP and we will walk through the TLF shells — how table and listing specifications link to ADaM datasets, and what the Pinnacle 21 validation workflow looks like at your data lock.