What's included

• Operational Clinical Trial Startup

  Comprehensive analysis of study protocols and associated documents to ensure accuracy and compliance with regulatory standards. Consultation services for training staff on protocol adherence and best practices, ensuring thorough understanding and compliance.

• Source Document Development

  Development of essential source documents based on the study protocol and electronic Case Report Forms (eCRFs), including other trial-related activities. This service also includes the crafting of comprehensive standard operating procedures (SOPs) to ensure consistency and regulatory compliance throughout the trial process.