Orgenix provides clinical services on four levels.

1. Study Management – Orgenix Clinical Trial Managers will provide Project Management Services for your Clinical Trial, providing you with assistance as needed. Study Management services can be scaled to fit your needs, from supplementing your staff in organizing the trial to providing a “Turn-key” project.
2. Site Management – Orgenix Clinical Trial Managers and Monitors are trained to assess the needs of each individual site and can provide the appropriate training and oversight to ensure the best quality data collection possible.
3. Monitoring – Sometime you need bodies. We can provide them.
4. Salvage – Stuff happens....

Our Clinical Trial Managers are experienced in managing all aspects of clinical trials. This includes, but is not limited to:

• Project Management
  
• Protocol development
  
• CRF development (paper or EDC)
  
• Informed Consent Form development
  
• Investigator Identification, Recruitment and Qualification
  
• Site Contract Negotiations
  
• IRB approvals
  
• Maximizing Patient Enrollment and Retention
  
• CRC training
  
• GCP development to Medical Device or ICH Standards
  
• Adverse Event recognition, reporting and resolution
  
• Randomization Services
  
• Investigator Agreements
  
• Financial Disclosure Documents

By acting as a Project Manager under the direction of your management team, Orgenix works seamlessly behind the scenes to provide you the service to complete your clinical trial.