During the course of new drug research, usually 70% cost and 2/3 time are
used for clinical trials. So how to decrease avoidable fault, and how to get
high quality result in a short time are the questions which need to be carefully
considered by the applicant during the design of clinical trials for new drug.
Take advantage of the special preponderance of Excellence Future CRO, the
applicant will half the work with double result. The time needed by Excellence
Future CRO can be saved by 1/3 to 1/4 of that the applicant needed.
According to the Chinese GCP (the 31st item), applicants can entrust contract
research organization to do relative clinical work and tasks. According to ICH－GCP
(the 5.2 item), applicants can hand over parts or all the clinical trial related
responsibilities and functions to the contract research organization. The
applicants will be responsible for the quality and integrity of the test data.
Contract research organization should apply quality control and quality
assurance.
Our services have expanded to drug inventions, preclinical researches,
pharmaceutical economics, information science, documents about clinical trials,
policies and rules consultation, production and package, generalization,
marketing, product distribution, sale support and commercial consultation. The
main projects include clinical research and general clinical research.
 We
can provides the following specialized services:
- The application of deputy drug registrations and clinical trials
- Translation and preparation of the application materials
- To draft and improve the clinical trial protocols
- To choose the clinical study institutions and investigators
- To provide and choose center lab
- To formulate SOP
- Blinding package of the drug for the investigational drugs
- Randomization multi-center and management
- Design of case reports form (CRF)
- Preparation of Investigator’s Brochure
- To arrange and coordinate the trial process;
- The safe report of investigational drugs and comparator drugs
- To make data processing and statistical analysis
- Quality control and quality assurance
- Compiling clinical trial study report
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