Expert consulting services for BioTech, Pharma, and CROs. 17+ years driving operational excellence from Phase I to IV studies.
為生物科技、制藥公司和CRO提供專業顧問服務。17年以上經驗，從第一期到第四期研究推動營運卓越。
Get in Touch 立即聯繫End-to-end support for clinical operations and development, from protocol design to regulatory submission.
從方案設計到法規申報，為臨床營運和開發提供全程支援。
Strategic planning and execution of clinical trials from startup to close-out, ensuring adherence to timelines, budgets, and quality standards.
從啟動到結案，全程策略規劃與執行臨床試驗，確保時程、預算和品質標準的遵循。
Comprehensive vendor management including selection, contracting, oversight, and quality control to ensure seamless trial execution.
全面的供應商管理，包括篩選、簽約、監督和品質控制，確保試驗順利執行。
Ensuring compliance with ICH-GCP, FDA, and international regulations. Support for IND submissions and regulatory agency interactions.
確保符合ICH-GCP、FDA和國際法規。支援IND申報和監管機構溝通。
Implementation of risk-based monitoring strategies, identifying and mitigating issues before they impact trial outcomes.
實施風險導向監控策略，在問題影響試驗結果前進行識別與緩解。
Preparing sites and teams for regulatory inspections with comprehensive TMF QC, storyboards, and compliance documentation.
透過全面的TMF品質控制、故事板和合規文檔，為監管查核做好準備。
Strategic timeline development, budget management, and cross-functional coordination to deliver studies on time and within budget.
策略性時程開發、預算管理和跨功能協調，確保研究按時且在預算內完成。
Get in touch to discuss how I can help accelerate your clinical development goals.
聯繫我討論如何協助加速您的臨床開發目標。
2173 Salk Ave, Suite 250 #2022
Carlsbad, CA 92008 US