Comprehensive Clinical Trial Expertise
- We have experts consisting of well respected, very experienced individuals in clinical trials including: registration, clinical operations and clinical supply. Team members have depth and breadth of knowledge in general clinical trial process, CRA and CTS along with GCP，GMP and GDP experience.
- Our consultation service includes:
- Clinical trial registration for both China and US including drafting M1, 2.3, 2.4, 2.6, briefing package, eCTD submission, regulatory strategy consultation, protocol drafting, etc.
- Clinical development plan
- Study drug management in both study level and country level, including Study drug sourcing globally, IP manual, study drug budgeting and forecasting, clinical supply strategy setting, contribute to clinical development plan and clinical protocol study drug related parts, packaging design, support IWRS/IVRS, warehouse management and study drug delivery, return and destruction; inspection support, etc.
- Patient safety:
- Clinical phase and post marketing safety signal and risk management
- Development safety update report, periodical safety update report, Risk Management Plan
- Pharmacovigilance Agreement and Joint Safety Review Committee charter
