Clinical Operation

• Project Planning
• Medical Writing
• Monitoring

Regulatory Affairs

• Strategic Review & Planning
• Pre-IND meeting
• IND, IRB/IDE, NDA Dossier Preparation, Submission

DM/STAT

• Data Management Plan (DMP)
• e-CRF Development
• Data Validation, quality check
• Statistical Analysis Sample size Calculation Randomization Management Statistical Analysis Plans Statistical Analysis Reports

QA/QC

• Quality Assurance Cycle (P-D-C-A)
• Annual Quality Assurance Plan
• SOP Management
• Audit (Internal/External)

Consulting

• Strategic Planning/ Project management
• Preclinical Toxicology and Efficacy consulting
• Site/Investigator consulting
• CMC/DMF/CTD consulting
• NDA consulting
• US FDA, SFDA, EMEA consulting