Capabilities

Capabilities

Essential Access Health's Research Center provides a full range of services for all phases of reproductive and contraceptive research from beginning to end - from study design and recruitment to preparing articles for publication.

Services Include:

  • Protocol Design (Phase I-IV)
  • Regulatory Compliance
  • Questionnaire and Survey Design
  • Strategic Recruitment Campaigns
  • Accelerated Enrollment
  • Data Processing and Management
  • Protocol Compliance Monitoring
  • Statistical Analysis
  • Manuscript Preparation
  • FDA Communications
  • FDA Audit Response
  • Essential Access Health Institutional Review Board Services

 

Types of Studies

 
Other Studies

  • Population-based surveys
  • Program evaluations
  • Cost-benefit analyses

 


 

Phase I: Safety, Tolerance, and Acceptability Studies of New Products

  • Microbiological studies
  • Performance evaluations (condom slippage and breakage)
  • Post-coital studies
  • Permeability, biologic marker studies
  • Focus groups

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Phases II and III: Efficacy Studies

  • Randomized clinical trials
  • Masked and open-label studies
  • Longitudinal follow-up
  • Multi-center enrollment
  • Bilingual capabilities

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Phase IV: Post-Market Evaluations

  • Provider surveys
  • Consumer surveys
  • Product surveillance
  • Adverse event tracking
  • Focus groups

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