Clinical Trials

Trial Design

  • Review Client Generated Clinical Trial Protocols
  • Develop and Negotiate with FDA 'minimalist' Clinical Trial Protocols
  • Design and Validate Informed Consent and Case Report Forms

Trial Management

  • Manage IRB-approval Process with Multiple Investigators
  • Recruit and Manage Clinical Investigator and Other Laboratory Sites
  • Manage Outcome Testing and Reporting

Data Management

  • Electronic and Standard (Paper) Data Acquisition Capabilities
  • Linked Databases that Ensure Patient Confidentiality and Provide Rapid Query Process
  • Quality Control Procedures that meet FDA Guidelines
  • Multiple Data Formats