Project Management

Coordination

• Trial design and optimization

  

• Investigator and site identification

  

• Site contracts and payments

  

• Presentations at symposia

  

• Manuscript preparation

  

• Clinical coordination

  

Regulatory

• FDA and HIPAA compliance

  

• Documentation following ICH and GCP guidelines

  

• Site monitoring

  

• Adverse event tracking and management

  

• Progress reports and renewals

  

• Support at FDA and international regulatory meetings

  

• Project termination