Driving Excellence in CDISC ADaM Implementation
The Analysis Data Model (ADaM) is one of the most important standards developed by the Clinical Data Interchange Standards Consortium (CDISC) as it provides a standardized framework for representing analysis-ready data — allowing reviewers to quickly assess and approve submissions.
As a CDISC registered provider, IDDI meticulously aligns every trial with FDA electronic submission standards, delivering database structures seamlessly transformed into ADaM formats and accompanied by the requisite documentation.
Our biostatisticians play a hands-on role in programming ADaM derivations and analyses, providing your research with an unmatched level of expertise and precision.
ADaM – Data Standards Implementation Services Tailored to Your Needs
Our ADaM implementation services help you deftly navigate the complexities of CDISC compliance, making your journey toward regulatory submission easy:
- Production of ADaM datasets
- Precise creation of define.xml and define.pdf files from ADaM dataset definitions
- Electronic validation of CDISC compliance to ADaM standards
- Creation of integrated ADaM datasets for comprehensive summaries of safety & efficacy (ISS/ISE)
Make Data Standards and ADaM
Implementation Fun With ID-Spectackle
IDDI’s Proprietary Graphical Interface
ID-Spectackle is a user-friendly graphical interface to help prepare ADaM specifications and create Define-XML for submission.
It automates metadata collection and provides guidance for filling in the specifications, helping to:
- Reduce error-prone copy-pasting of redundant information
- Ensure specifications and datasets are aligned
- Provide consistency checks with completion rules
- Keep the system updated with evolving standards
- Clarify and deploy a standard process company wide
Uncompromising Excellence in Data Standards – ADaM Implementation
If you want to generate compliant datasets from the start, you need to partner with IDDI.
