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For Sponsors/CROs

DRUG/DEVICE DEVELOPMENT

CNI can provide these services in whole or in part.

• Discovery-to-Development (Translational Medicine)
• Site Recruitment/Investigator Selection
• Phase I through Phase IV trials
  • Monitoring
  • Auditing
• Remote Data Entry (e-CRFs)
• Medical Writing
• Protocols
• Investigator Brochures
• Study Reports
• Filing INDs
• Regulatory Affairs
• Quality Assurance
• Standard Operating Procedures

CONTRACT PROFESSIONALS

Project Manager
National and International Project Managers can be provided and serve as the pivotal role in the successful execution of a clinical trial.

PhD/Scientist
Scientists are available for fostering translational medicine programs, protocol and program development, and data analysis.

CRA
Senior Clinical Research Associates are available for monitoring Phase I-IV clinical trials, nationally and internationally.

Auditor
GCP auditors are available to develop a comprehensive auditing plan or conduct a single site audit.

Study Coordinator
To meet a temporary need for data management or regulatory document processing, a contract study coordinator can make the difference between a goal met and a goal missed.