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Stellar Systems brings domain knowledge and experience in four interrelated disciplines in order to serve the needs of our clients:


Information Technology Regulatory Knowledge
System Design & Architecture

Data Integration & Translation

Complex Database Design

Security & Data Integrity

Intranet/Internet Development

Information Portals

Managed Application Services

21 CFR Part 11 (eSignatures & electronic records)

FDA GXP (Good Clinical, Good Manufacturing, & Good Lab Practices)

MedDRA (Medical Dictionary for Regulatory Activities)

HIPAA (Healthcare Insurance Portability & Accountability Act)

Section 508B Compliance (Web & Software Usability for Federal Use)

Project Management Biopharmaceutical Systems
Requirements & Needs Analysis

Cost-Benefit & ROI Analysis

Resource Management

Project Planning & Implementation

Structured Software Development

Subcontractor Management

Clinical Data Management

Research Collaboration

Clinical Trial Support

Medical Vocabularies

Adverse Event Reporting Systems

 

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