Security, Quality & Compliance

Confidence in your platform.
Freedom to move forward.

Your teams need to advance clinical research with confidence in the technology and people behind it. CDP brings together disciplined quality practices, governed data and the Microsoft foundation to support your organization across studies.

More than 20 yearsof experience in clinical research

Longstanding approved-vendor status
with multiple Fortune 500 companies.

Quality throughout the lifecycle

Confidence starts with
how the work gets done.

Our quality management practices and documented procedures guide how we develop, test and maintain CDP. Clinical research experience shapes the decisions behind the technology, from initial requirements through ongoing improvement.

Start with your requirements.

Understand your processes, intended use and research requirements. Define how CDP should support your teams, with responsibilities and expectations established from the outset.

A clear basis for the work ahead.

Build with quality in mind.

Bring disciplined development, testing and validation practices to the software lifecycle. Our quality processes guide how work is documented, reviewed and prepared for use.

Confidence supported by process and evidence.

Maintain control as needs evolve.

Evaluate changes in the context of existing workflows and responsibilities. Connect software improvements with review, documentation and practical support for the people who use them.

Progress with continuity and oversight.

Security & privacy

Connect your teams.
Protect what matters.

Making clinical data more useful also means governing who can access it, how it moves and what people can do with it. CDP brings those considerations into the way your organization works.

Guided by Zero Trust principles

Verify explicitly. Use least-privilege access. Assume breach.

Microsoft’s Zero Trust approach

Access aligned with responsibility

Role-based permissions and least-privilege principles help people work with the studies, sources and information they are authorized to use.

Privacy within your workflows

Keep sensitive clinical information within defined access and use boundaries as teams collaborate across studies and organizations.

Traceability that preserves context

Maintain the relationship between source data, transformations, review activity and downstream use, so teams can understand the information behind a decision.

Built on Microsoft for Healthcare

Enterprise protection.
Clinical expertise.

Microsoft Azure provides a foundation for security, resilience and data protection. Simplified Clinical applies that technology within CDP through our application design, quality practices and clinical research experience.

We work with your teams to align configuration, access and operating responsibilities with your environment.

Explore our Microsoft foundation

Compliance in context

Your requirements.
A shared commitment.

Your organization has its own protocols, responsibilities and vendor-qualification requirements. Our longstanding approved-vendor relationships with large enterprises give us experience supporting that evaluation process.

We work with your clinical, quality, IT and procurement teams to discuss platform controls, documented quality practices and the requirements applicable to your research.

  • 21 CFR Part 11
  • HIPAA
  • GDPR
  • GxP

Enterprise vendor qualification

Support for your vendor evaluation.

  • Discuss intended use, organizational policies and research workflows.
  • Review relevant platform controls and quality practices.
  • Align access, review and approval responsibilities.
  • Identify documentation and qualification needs for your organization.
Let’s discuss your evaluation

Responsible AI

New possibilities.
Enduring accountability.

Standards guiding our AI development

  • Governed
  • Traceable
  • Version-controlled
  • Continuously monitored
  • Auditable
  • Fit-for-purpose validated
  • Human-supervised

As we expand CDP’s AI capabilities, Microsoft Foundry, Microsoft Foundry Control Plane and Microsoft Purview will support continuous monitoring, evaluation and data governance.

Our quality, development and change-management practices will guide validation for intended use. Qualified people retain responsibility for review and approval.

Explore governed analytics & AI

Take the next step

What does your organization need to move forward with confidence?

Bring your clinical, quality, IT and procurement teams into the conversation. We’ll discuss your priorities, vendor-qualification requirements and what you need to evaluate CDP.