Clinical Trials

---

Trial Design

Trial Management

Trial Management

• 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

Trial Management

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

Trial Management

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