Smart Data Quality (SDQ)
Integrated Data Review Assist (IDRA)
Integrated Data Review Assist brings data-review-plan creation, collaborative review, and compliance tracking together — with check recommendations by therapeutic area and metadata.
One platform for the data review plan
Integrated Data Review Assist (IDRA) helps study teams create, review, and track the data review plan efficiently, improving compliance with GCP and other regulations. It replaces disconnected plan documents and spreadsheets with a single platform used by every stakeholder.
IDRA recommends checks based on therapeutic area and metadata, supports collaborative review with modern UI components, and logs every change to the audit trail for full traceability.
Why teams choose IDRA
Unified review-plan platform
One place to create, review, and track the plan, used by every stakeholder.
Recommendation-driven setup
Checks recommended from the library and similar studies by therapeutic area and metadata speed creation and reduce programming effort.
Collaborative review
Reviewers comment at plan and check level and request modifications; owners close comments and finalize.
Compliance and traceability
Automated metadata-change detection plus a full audit trail and compliance reporting.
One platform
How IDRA works
IDRA follows a three-stage lifecycle: Draft, In-Review, and Reviewed.
The owner builds an IDRA for a study using recommendations from the library and similar studies, inherits checks from other studies, or adds and imports custom checks.
Assigned reviewers add plan- and check-level comments and request modifications; once all reviewers mark the plan reviewed, the owner closes open comments and moves it to Reviewed.
Run compliance and execution reports and download the IDRA in CSV and PDF, with full version history.
Features
Overview, Checks, History, and Comments.
Import an existing library via CSV and edit, activate, or inactivate checks individually or in bulk.
Automatic detection of impacted checks with quick filters for impacted and updated items.
Track every version and download in CSV and PDF.
A compliance report of data-review activity versus the expected review frequency, detailed metrics per IDRA check by review method, and a granular per-query audit trail with time-to-review metrics — downloadable in CSV and PDF.
