RCRI - Medical Device CRO    
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ISO 9001:2000 CERTIFIED SERVICES:

 
Regulatory Affairs Regulatory Affairs
Clinical Trial Design & Management Clinical Trial Design & Management
Database Development & Compliance Database Development & Compliance
Reimbursement Strategy and Implementation Reimbursement Strategy and Implementation
Health Economics Health Economics
Quality Systems & Compliance Quality Systems & Compliance
Biostatistics Biostatistics
Venture Capital Due Diligence Venture Capital Due Diligence

 

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Medical Device Clinical Trial Design & Management

CLINICAL TRIAL DESIGN & MANAGEMENT

Developing a Strategic Clinical Plan

The Regulatory & Clinical Research Institute offers comprehensive services to develop a clinical plan that meets your business goals including:
  • Clinical trial strategy and design development
  • Investigational plan creation
  • Analysis plan development
  • Investigator and site identification, recruitment, and qualification
  • Study document development
  • Site initiation and training
  • Database development, including EDC options
  • Data and query management
  • CEC/DSMB management
  • Study monitoring
  • Site and sponsor auditing
  • Statistical analysis
  • Clinical report generation
  • Presentation and journal article preparation
  • SOP development
  • Comprehensive staff training


 

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