Clinical Research

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)

Development Pipeline