Clinical Trial Analytics 2

Operate more efficiently today, discover what may be possible tomorrow.

DATA COLLECTION, MANAGEMENT, ANALYTICS & AI – SIMPLIFIED

The Clinical Discovery Platform (CDP) provides a governed, end-to-end foundation for clinical trial data collection, management, analytics and responsible AI. It combines more than 20 years of Simplified Clinical’s regulated-technology experience with Microsoft’s cloud, data, governance, analytics and AI ecosystem – reducing the burden and uncertainty of assembling that foundation independently

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AI Changes the Possibilities – Not the Standard.

In clinical research, technology without regulatory compliance has no practical value; compliance is the sine qua non. CDP’s
AI strategy follows the same discipline that has guided Simplified Clinical since 2003.

The CDP Approach: Capture. Create. Activate.

FABRIC MEDALLION LAKEHOUSE

Capture

Unified electronic data capture

Traditional EDC
ZDE™ / eSource
RWD, APIs & devices

Create

Validated, governed clinical data

Cleaning & validation
Queries & audit trails
Curated, analysis-ready data

Activate

Operational efficiency & discovery

Power BI analytics
AI-assisted management
Clinical AI agents

MICROSOFT CLOUD FOR HEALTHCARE | AZURE | FABRIC & ONELAKE | PURVIEW | POWER BI | MICROSOFT FOUNDRY

What Responsible AI Means in CDP

Governed data

Access, lineage and protection

Human Oversight

Review and approval where needed

Traceability

Auditable data and AI-assisted

Fit for purpose

Validation and monitoring by
use case

A full-stack clinical data and AI ecosystem. CDP connects the complete clinical data lifecycle to the data, governance, analytics and AI services required to create trusted operational and scientific value

Important: Technology alone does not confer regulatory compliance. Compliance depends on configured controls, fit-for-purpose validation,
documented procedures and disciplined operation.

Established Trust. Built for What Comes Next

Simplified Clinical is extending an established, regulatory-focused clinical platform – not introducing AI from an
untested starting point. Long-term relationships, demanding audits and high-consequence programs demonstrate
the operational foundation behind the next generation of CDP.

Evidence that Reduces Adoption Risk

15-YEAR RELATIONSHIP | COVID-19 RESPONSE

Abbott Rapid Diagnostics

Abbott’s Clinical Data Management team used
established processes built around CDP to launch multiple
urgent studies in days or weeks rather than months. CDP
supported collection, cleaning and analysis readiness of
data used in EUA submissions, including the BinaxNOW
program.

CLINICAL JOURNEY | PILOT TO APPROVAL

MicroTransponder / Mobia

MicroTransponder states that Simplified’s EDC supported
pilot studies, its pivotal stroke trial and an ongoing
registry. FDA approved the Vivistim(R) System in August
2021; pivotal trial results were published in The Lancet.

“Put simply, Simplified is always my first choice when developing a new study data capture system.”
ROSALYN ARCHER | CLINICAL DIRECTOR, OSSDSIGN AB

The Strategic Opportunity

Why Now

Sponsors and CROs see AI’s potential, but
uncertainty around integration, governance, validation and regulatory expectations slows responsible adoption.

Why CDP

CDP joins clinical workflows with Microsoft’s data, governance, analytics and AI ecosystem in one implementation-ready
platform foundation.

Why Simplified

More than 20 years of regulated delivery,
long-standing relationships and a founding
commitment to clinical technology that
remains intuitive.

Clinical Data Collection, Management, Analytics & AI – Simplified.

A governed clinical data and AI ecosystem designed to improve operational efficiency, reduce implementation uncertainty
and accelerate discovery – while preserving the regulatory discipline clinical research demands.

Your next discovery may already be in your clinical data.

CDP helps you bring the evidence together, explore what it may reveal, and determine what deserves further investigation—all through a private Clinical Data Lake powered by Microsoft Fabric.