Human expertise remains central
Our platform augments biostatisticians and programmers rather than replacing them. Human review, judgment, and accountability remain essential throughout the workflow.
Solutions
Our end-to-end model.
idaptiq automates and connects the core biostatistics deliverables required for FDA and other regulatory submissions — SAP, SDTM, ADaM, and TLFs — across the complete biostatistics lifecycle rather than optimizing single steps.
End to end
Protocol to TLFs.
The platform uses uploaded core study documents to produce the required outputs at each step.
01
Core Documents
Protocol, CRFs, Database Specifications.
02
SAP
Text + TLF Shells.
03
SDTM
Specifications + Code + aCRF.
04
ADaM
Specifications + Code + TLF shell annotations.
05
TLF
TLF Code.
idaptlinq™
Links biostats deliverables, automating downstream re-work when protocol amendments or other changes are identified with automatic dependency detection.
Deeply interconnected
Amendment aware
Institutional knowledge retained
Our Principles
Our Commitments to Customers
Patient data protection is absolute
Patient data is not processed, transferred, or stored in the idaptiq cloud. Patient data does not go through an LLM. Security and privacy are paramount.
The customer owns the study
Customers retain ownership of their data, documents, decisions, workflows, and final deliverables. Customers adhere to their own QC checks, SOPs, and compliance requirements.
Trust is earned through transparency
Users must be able to understand the source of system-generated outputs. Audit trails are visible.
Regulatory and scientific integrity are non-negotiable
The platform supports compliance with industry standards, regulatory expectations, and customer quality processes. Speed and automation should never come at the expense of scientific rigor.
Biostatistics deliverables are connected via idaptlinq™
All deliverables are digitally connected via idaptlinq™, capturing relationships and inter-dependencies. We address the entire workflow, not isolated tasks.
Changes happen in clinical trials. They should propagate intelligently
The platform tracks the impact of changes (e.g., protocol amendments), upstream and downstream across the biostatistics lifecycle, preserving validated content, and generating targeted recommendations for impacted deliverables. All changes are traceable.