Excellence Future possesses global technology and clients as a CRO. Its core business activities are the clinical study on patented 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 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 overseas medicine manufacturing enterprises .
Excellence Future closely cooperates with national new medicine clinical trial bases . 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 domestic and overseas companies .
At the same time, we provide several special technical services of application of FDA registration for domestic drug companies , 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 cycles . 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 qualit y control system.
As an experienced CRO, Excellence Future has many advantages in its specialized field:
• F amiliar with related government drug management rules and practical regulations
• Understanding of international practices and guiding principles for medicine clinical trials
• Going in for drug clinical trials in many fields
• Choosing some consultants to make an effective and practical trial plan
• Organizing clinical trial according to international SOP
• Implementing quality control and quality assurance during the course of clinical trials
• To carry out data processing and statistical analysis of clinical trial results
• Drafting clinical test study reports in line with standards
During the course of new drug research, usually 70% of costs and 2/3 of valuable time are used for clinical trials. So how to decrease avoidable fault, and how to get high quality results in a short time are the questions which need to be carefully considered by the applicant during the design of clinical trials for new drugs . Taking advantage of the special preponderance of Excellence Future CRO, the applicant will cut the work in half while doubling the results . Excellence Future CRO can save the applicant 1/3 to 1/4 of the time the applicant originally anticipated.
The general plan of its quality
According to the Chinese GCP (the 31 st 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 of 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 organizations should apply quality control and quality assurance.
• Every step of the management should be applied according to international SOP
• Overall and systematic service systems may provide valuable service to the consignor
• To feed back information to the consignor quickly and on time, to ensure lucidity of the cooperation
• Strictly observe and faithfully fulfill every item of the contract from the beginning of the contract
• All of the staff 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 research , pharmaceutical economics, information science, clinical trial documents , policies and rules consultation, production and packaging , 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
• Translating and preparation of the application materials
• Drafting and improving the clinical trial protocols
• Choosing the clinical study institutions and investigators
• Providing and choosing center lab
• Formulating 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
• Arranging and coordinating the trial process
• The safe report of investigational drugs and comparator drugs
• Making data processing and statistical analysis
• Quality control and quality assurance
• Compiling clinical trial study report
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