Core Functions Composing TOT's Medical Team
- Clinical Operation: To submit protocol, consent documents to regulatory and EC/IRB for approval. Also, to manage clinical trials accordingly within specified timeline, budget and quality standards.
- Medical Science: To design clinical trial base on product’s property and development status. To communicate with investigators focusing on protocol, process and publication.
- Global Clinical Development: To evaluate clinical trial and drug development environment in global. To manage project plan, clinical operation, CRO/vendor, budget and all trial related activities.
- Pharmacovigilance: To practice the drug safety related activities. With a view to identify the new information to ensure patients are getting safe and effective drugs.
Quality Control / Quality Assurance: To standardize and upgrade quality of clinical development continuously with systemic training and auditing.
- Statistics/ Data management: To create database, programming of data validation rules and statistical analysis, audit trail design and maintain, Statistical report completion.
Contributions for Drug Development in Oncology Fields
- There are 78 TFDA/IRBs submitted/approved phase I to phase III clinical trials conducted/planned from 1996 to April 2014.
- Many disease categories investigated included CRC, GC, BC, and specialized in Chinese prevalence cancers.
Publications - by Year (until 2014.03)