Clinical Data Management
End-to-end data management powered by the IQA PICSS™ framework, from DMP and CRF design through database lock, CDISC-aligned delivery, and archival.
Data Integrity Built In From Day One.
Clinical Data Management at IQA is built around one principle: data integrity must be designed in from the start, not repaired later. Our teams support clinical trials, medical device studies, RWE and observational programs, registries, IITs, and hybrid or decentralized studies with ALCOA+ discipline embedded into day-to-day data operations.
Using the IQA PICSS™ framework - Plan, Implement, Conduct, Signal, Sustain. We run a metadata-driven CDM model that connects reusable CRF specifications, intelligent edit checks and validation, real-time RBQM signals, and audit-ready documentation. Whether your study runs on InductiveEDC, Medidata Rave, Veeva Vault CDMS, we help deliver clean, submission-ready data and a locked database on time.
ALCOA+ in Practice
The CDM Lifecycle - Plan to Sustain.
Five interconnected stages. One metadata-driven framework. Complete end-to-end accountability.
Clinical Data Management from Study Start-Up to Database Lock
Structured, quality-driven data operations across build, conduct, review, and closeout.
Study Start-Up
Protocol review, DMP, CRF/eCRF design, edit checks, database build, and UAT planning
Study Conduct
Data review, query management, coding, external data reconciliation, and ongoing QC
Review & Oversight
Listings, review metrics, RBQM signals, protocol deviation review, and lock-readiness checks
Database Lock & Closeout
Final reconciliation, query closure, coding completion, database lock, archival, and downstream handoff
Technology That Strengthens Every Layer of Clinical Data Management
Our connected solutions support study build, data validation, coding, protocol-driven design, and real-world data workflows - helping teams deliver cleaner data, faster reviews, and audit-ready execution.
Platform-Agnostic. Proficient on All of Them.
Our CDM team holds certified expertise across the industry's leading EDC and data management platforms - with validated build capability, experienced administrators and complex study execution across 100+ deployments.
Your Stack. Our Expertise.
We work within your chosen EDC ecosystem - or recommend the right platform for your study. Our team holds build and admin certifications across all major platforms, with proprietary InductiveEDC as our flagship CDM engine.
Every Dataset. Submission-Ready.
CDISC implementation guide standards with Pinnacle 21 (P21) validation - zero critical issues.
Clinical Data Management Built for Integrity, Control, and Submission Readiness
Metadata-driven workflows, platform flexibility, intelligent validation, and submission-ready standards, brought together in one connected CDM delivery model.
IQA PICSS™ Framework
A metadata-driven CDM model combining reusable specifications, governed workflows, and end-to-end traceability from startup through lock and archival.
Platform-Agnostic, Platform-Proficient
Experienced across leading EDC and CDMS platforms, including InductiveEDC, Medidata Rave, Veeva Vault CDMS, Oracle Clinical One, Medrio, and TrialMaster.
Smart Data Validation with CDQOps
Automated edit checks, cross-dataset review, QC dashboards, and RBQM-informed signals that surface issues early.
CDISC-Aligned, Submission-Ready Delivery
CDISC-aligned delivery across SDTM, ADaM, Define-XML, controlled terminology, and CDASH-aligned acquisition design.
Extended CDM Through Coding and Real-World Data
Extended CDM support through AI-assisted coding, registries, observational studies, and post-market data workflows.
Audit-Ready by Design
ALCOA+, GxP-aligned documentation, 21 CFR Part 11–compliant environments, GDPR-aware governance, and inspection-ready delivery from day one.
What This Means for Your Program
Build Your Next Study on a Stronger Data Foundation
From study startup through database lock and archival, IQA helps you deliver clean, compliant, submission-ready data with confidence.