When to Contact Us

How We Can Help You

During the planning process to

  • Provide protocol and project design expertise to meet the needs of investigators, sponsors and institutions
  • Redesign of protocol and programs to improve quality and timeliness
  • Initiate and coordinate site qualification and site initiation visits
  • Negotiate Confidential Disclosure Agreements (CDA). Clinical Trial/Study Agreements (CTA/CSA) and budgets
  • Plan and conduct investigator meetings and study staff training meetings
  • Recruitment and retention planning including recruitment materials and strategies

During the Study

  • Site assessment, start-up or monitor visits
  • IRB submission, maintaining regulatory files
  • Trouble-shooting, quality control
  • Implement protocol changes and amendments
  • Coordinate Food and Drug Administration (FDA), sponsor or National Institutes of Health (NIH) audits.
  • All regulatory, budgetary or other study related issues


  • Special Populations
  • Multi-Site Coordination
  • Data Coordinating Center
  • Protocol Design
  • Phase I-IV Services
  • Recruitment & Retention
  • IND / IDE Services
  • Monitoring & Quality Assurance
  • Research Kit Production
  • PK /PD Modeling & Simulation
  • Data Analysis
  • Project Management

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