Tags: | NMPA | Pharmaceuticals | Drug | 药监局 | 医药品 | 药品 |

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:

1. The application of deputy drug registrations and clinical trials
2. Translation and preparation of the application materials
3. To draft and improve the clinical trial protocols
4. To choose the clinical study institutions and investigators
5. To provide and choose center lab
6. To formulate SOP
7. Blinding package of the drug for the investigational drugs
8. Randomization multi-center and management
9. Design of case reports form (CRF)
10. Preparation of Investigator’s Brochure
11. To arrange and coordinate the trial process;
12. The safe report of investigational drugs and comparator drugs
13. To make data processing and statistical analysis
14. Quality control and quality assurance
15. Compiling clinical trial study report