Observer in drug
Proposer of industry
Innovator on the
China GCP Salon founded
China GCP Union founded & preparing for Zhongguancun Industry Alliance
ZHONGGUANCUN JIUTAI GOOD CLINICAL PRACTICE UNION founded
Standard System Construction on drug clinical trials/industry studies implemented
Official website/Wechat public number opened
Held cross-strait“On-site Academic Exchange on Drug Clinical Trials Management”
Launched the platform of clinical study service and established the big data platform on pharmacogenomics
Implementation of auxiliary tool of drug clinical trials management
Released “Field Evaluation Standards on Centralized Management of Drug Clinical Study”
Delegation visited US,developing nationalized cooperation and exchange
Collaborating with the Alliance members,obtained 2 projects’ support on“Precision Medicine Research”of National Key R&D Program
Visited Italy for ITALY-CHINA SCIENCE, TECHNOLOGY AND INNOVATION WEEK
Registration on“NATIONAL ORGANIZATION STANDARD INFORMATION PLATFORM“
Released “Industry Guidebook for CRC”
Initiation of developing “ Industry Guideline for China CRO Management”
Started the building of training platform
Collaborating with the Alliance members obtained 8 projects of New Drug Innovation Platform, and 1 project of key R&D program about Chronic non-communicable diseases
A general election and new leadership group confirmation
Establishment of Committee on clinical study of cell therapy& biological agents
Attended 2018 World Life Science Conference and co-organizer of 2020 World Life Science Conference
Let the innovation mechanism goes first,
to promote the implementation of state policy
support professional innovation
mechanism,mprove the ecological
environment of clinical study,forge and
train professional talents,tackle all kinds of
bottleneck issues of clinical study
Explore the cross-domain application of
innovation technology such as big data, AI,
innovative biotechnology, message block, to
comprehensively improve the quality of
clinical study, the discovery of core
technology，and the efficiency in
transforming scientific research achievement
into production technology.
Referring internationally recognized
standards, to develop and spread standards/
guideline on clinical study with Chinese
characteristics, push the orderly
development of industry regulations,
enhance the voice of
China's pharmaceutical industry in the world.
Based on upstream and downstream industry chain,promoting new technology
for novel commercialization by setting new standards to build
a new form of industrial organization integrated system of production, teaching
and research, cross-border integration , collaborative innovation.
Build membership service system
Application of innovative technology
Innovation on industry management mechanism
Standard establishment on urgently need
“Internet+big data” membership service platform
Explore the platform of trans-domain innovation technology conversion
Organize and implement industry management innovation mechanism
Implementation the standard system of clinical study and experiment
Build the link of industrial chain on innovative clinical study platform
Research center for innovative medical transformation
China clinical trial management organization platform with efficiency and high quality
Internationally recognized standards on clinical study and research with chinese characteristics
Collaborative innovation on multi-organizational,
boost resource conformity, knowledge sharing , rule exploration , enhancing industry vitality
Constantly strives to research on technology strategy, participates in lots of planning and surveillance of national science and technology projects.
Published over 70 articles on SCI Indexed Journals such as Science, Nat Med, Nat Biotech, Cell Res,and is cited more than 1200 times;
Won one first prize in National Teaching Achievement Award, one second prize in National Science and Technology Progress Award,two first prizes & five second prizes in provincial and ministerial level Teaching Achievement Award .
Vice-Chairman of Drug Clinical Trial Professional Committee of CPS
Expert reviewer of the National Technology Invention Prize and technology advancement prize
Responsible expert in National Science and Technology Major Projects for "Major New Drugs Innovation and Development" of the Chinese Ministry of Science and Technology
Financial acceptance expert of National Science and TechnologyMajor Projects , National Science and Technology Major Projects of the National Health and Family Planning Commission
Member of committee on assessment of the protected traditional Chinese medicinal products of CFDA
Evaluation expert in Drug evaluation center of National Development and Reform Commission
Evaluation expert in Investment Assessment Center of PRC Minister of Finance
Expert in EML Group of drug administration of National Health Commission
Base on the Upper,Middle and Lower Reaches of Industry ，Integrating resources of production, education, research and medicine. Building a platform for resource docking and cooperation for various parties in clinical study such as pharmaceutical enterprises and medical institutions/ researchers and third party service agencies，pushing the high quality resources develops both in scope and in depth.
Consultation and technology service in each link of drug or medical device clinical study
Assistant tools—Real-time Help System of clinical study projects：an easy and convenient interactive assistant tool on clinical study that independently developed by the Union, which is able to a flexible customization by features of specific clinical study. It ensures the good clinical practice and traceability of data.
By providing quality control tool and system to hospitals, establish a systematic alert mechanism for a real-time tracking of projects to help center and applicant improve quality management ability.
Provide independent third-party audit and evaluation on center capability from aspects as centers、 ethic committee、professional ability，promoting the standardized development of industry.
Online GCP training—qualification for drug clinical trial institution, inspection review, simulation inspection、 continuing education(before 2018);
Promotion of vocational skills—cooperate with first-class universities and institutions at home and abroad, hold vocational skills training and qualification improvement for all kinds of personnel in the clinical study such as PI、CRC、CRA;
Live broadcasting on industry conferences;
KOL lectures and high-end academic salon.
Developing and promoting practical guidelines and standards of Good Clinical Practice， build and optimize innovative drugs and innovative technology environment，promoting the standardized development of industry. To date，the Union has completed the registration on“NATIONAL ORGANIZATION STANDARD INFORMATION PLATFORM“, released 2 Union standards as“ Industry Guidebook for CRC”、“Field Evaluation Standards on Centralized Management of Drug Clinical Study”,conducted research about “Quality Control and Management Standards of Cell Therapy”.
Provide professional consulting service to our members and society； focus on industrial key research directions，organize prospective study on industry trends，provide advices for national formulation and improvement of relevant policies and regulations.
By participation and organization of various international academic exchanges， actively implementing the "Going Out" strategy，seeking more opportunities for cooperation with international academic organizations ，combining industrial needs and characteristics of clinical study, actively introducing international advanced technical standards and innovation mechanisms，connecting international and advanced management practice.
Union Delegation to the United States for Exchang
Secretary general Cao Cai with technical team from Chinese Academy of Sciences visited Ken-ichi Arai Ken-ichi Arai in Japan
Visited Italy for ITALY-CHINA SCIENCE, TECHNOLOGY AND INNOVATION WEEK
Hold cross-strait“On-site Academic Exchange on Drug Clinical Trials Management”
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