Excellence Future possesses global technology and clients as a CRO. Its core business activities are the clinical study on patent and generic medicine, FDA registration & consultation and technology transfer. It mainly provides full course services of related research, development and technical service and consultation for the clients all over the world.
Based on its local situation, Excellence Future provides services of new medicine clinical trials for domestic medicine manufacturing enterprise, by international norms and national common used price standards. At the same time it provides multi-center clinical study services which are in accordance with the requirements of ICH and GCP for the overseas medicine manufacturing enterprises.
Excellence Future cooperates with the national new medicine clinical trial bases closely. It provides full course services of Phase I, Phase Ⅱ and Phase III clinical trials of new medicine, as well as the Phase IV clinical trials after the new medicines become available in the market, including clinical pharmacokinetics research, bioequivalence research and biological availability research of the medicine, which provide an international standard platform for the domestic and overseas company.
At the same time, we provide several special technical services of application of FDA registration for domestic drug company, including writing materials of FDA registration, bioequivalence research, medical statistics and management of the clinical data according to the concrete requirement of FDA, deputy of application of FDA registration, doing FDA mimicry verify of new drugs. It cooperates with domestic and overseas research institutes and medicine manufacturing enterprises to conduct technology transfer, introduce/output and generalization of medicine patents.
The purpose of Excellence Future is client centered “sincerity creates future”, and it tries to get valuable time for client through all-round and high quality clinical medicine trial services and fast, effective development cycle. With experienced specialized administrator, Excellence Future closely cooperates with the new national medicine clinical trial bases. By high quality, scientific and effective management ideas, we strictly manage the project in accordance with the requirements of ICH, FDA and GCP, and we have also established a systematic, standard, and perfect SOP as well as the quality control system.
As a ripe CRO, Excellence Future has many advantages in its specialized field:
- Be familiar with related government drug management rules and practical regulations
- Understanding the international practices and guiding principles for medicine clinical trials
- Going in for drug clinical trials in many fields
- Choosing some investigators to make an effective and practical trial plan
- Organizing clinical trial according to international SOP
- Implying quality control and quality assurance during the course of clinical trial
- To carry out data processing and statistical analysis of clinical trial results
- Drafting clinical test study report in line with standards
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.
The general plan of its quality
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.
- Every step of the management should be applied according to international SOP
- Overall and systematic service system may provide valuable service to the consignor
- To feed back information to the consignor quickly and in time, to ensure lucidity of the cooperation
- Strictly observe and faithfully fulfill every item of the contract since the beginning of the contract
- All the staffs are responsible for the service quality of Excellence Future
- Our aim is to gain 100% satisfaction of clients
The services of Excellence Future 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.
Non-clinical research including:
- The determination of stability and shelf life of the drug and its preparations
- Physicochemical property of drugs
- The determination of purity and impurity
- Microbiological test
- The analysis of environmental effect
- Non-clinical pharmacology
- Toxicology
- Pharmacokinetics
Excellence Future 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 |