Life Sciences & Public Health Tech

Analytics, compliance support, and operational efficiency for life sciences firms and public health technology companies navigating complex regulatory environments.

Industry Challenges

1

Complex regulatory compliance (FDA, GxP, 21 CFR Part 11)

2

Clinical trial data management and analysis

3

Need for real-world evidence and outcomes research

4

Integration of disparate research and operational systems

5

Accessibility requirements for patient-facing digital health tools

How Nine Alpha Helps

Specialized solutions for regulated life sciences environments

Nine Alpha Data

Clinical trial analytics, real-world evidence studies, and outcomes research. Data integration and governance for R&D and commercial operations.

Nine Alpha Ops

Clinical operations workflow automation, regulatory submission process optimization, and quality management system modernization.

Accessibility & Compliance

Section 508/WCAG compliance for patient platforms, combined with GxP and 21 CFR Part 11 compliance advisory.

Representative Use Cases

Clinical Trial Data Platform

Built integrated data platform consolidating EDC, safety databases, and real-world data sources, enabling faster insights and regulatory submissions while maintaining compliance.

Real-World Evidence Study

Conducted outcomes research using claims data and EHR records to support product labeling expansion, demonstrating treatment effectiveness in diverse patient populations.

Patient Portal Accessibility

Assessed and remediated digital health platform for WCAG 2.1 AA compliance, ensuring inclusive access for patients with disabilities while maintaining HIPAA security.

Explore a Partnership

Let us discuss how Nine Alpha can support your life sciences or health tech organization.