CliniTransformR

A programming suite that turns collected study data into CDISC compliant SDTM and ADaM datasets, with traceability from every value back to its source.

SDTMADaMCDISC

Clinical Data Pooling Platform

Pools standardized data across studies for integrated summaries of safety and efficacy, cutting the manual effort behind ISS and ISE work.

ISSISEIntegrated Analysis

Clinical Reporting System

Produces tables, listings, and figures for clinical study reports, with version control and quality control built into each run.

TLFCSRQuality Control

Metadata Studio

Manages dataset specifications and define.xml from a single source, so the documentation and the data stay in step throughout a study.

MetadataDefine.xmlSpecifications

autotestpkg

An automated testing framework for R packages that shortens qualification work, which makes it practical to validate analytical tooling for regulated use.

ValidationGxPTesting

QC Companion

Runs structured checks on datasets and reporting output, catching standards and consistency issues before they reach a reviewer.

Quality ControlChecksStandards

Rmarker

Generates technical, analysis, and validation documentation directly from your code and specifications, reducing the paperwork around every deliverable.

DocumentationValidation Docs

Literature and Safety Monitor

Collects and organizes published literature and safety sources for pharmacovigilance teams, keeping surveillance structured and current.

PharmacovigilanceLiteratureSurveillance
How We Deliver

Configured to your process, supported for the long term

We do not hand over a fixed product and walk away. Each platform is set up against your standard operating procedures and your data standards, then validated for your environment.

Your teams are trained to run it, and our support stays in place as standards change and studies move through their phases.

What comes with every deployment

  • ConfigurationSet up to your SOPs, standards, and therapeutic areas.
  • ValidationQualification evidence and documentation for regulated use.
  • TrainingYour programmers and statisticians learn to own it.
  • SupportOngoing maintenance with defined service levels.

Want a closer look at any platform?

We can walk you through how each one works and how it would fit your studies.

Request a walkthrough