국가임상시험지원재단

2023

• JAN.25

  In-seok, Park, inaugurated as the 3rd Chairman of the KoNECT

• JAN.13

  Signed a Letter of Intent(LOI) with Osaka University Hospital in Japan to build an Asian network

• JAN.12

  Signed the Korea Drug Development Fund business agreement(MOU) for domestic new drug development and pharmaceutical industry development

2022

• NOV.30

  Signed a business agreement (MOU) with the Korea Research Institute of Bioscience and Biotechnology to establish a preclinical-clinical linkage system

• NOV.16

  Signed an MOU with Daegu-Gyeongbuk Advanced Clinical Trial Center and Cheongju-Osong Advanced Clinical Trial Center to establish KoNECT regional base education center

• NOV.15

  Signed a business agreement (MOU) with the Health Insurance Review and Assessment Service for the use of healthcare big data and the development of the clinical trial industry

• NOV.14

  Preparing a roadmap for rapid development of future infectious disease treatments and vaccines

• NOV.10

  Signed an agreement with Cellid to recruit participants for clinical trials and use public platforms for the development of booster vaccines exclusively for Omicron

• NOV.04

  Held Clinical Trial Digital Transformation Research Group Forum 2022

• NOV.04

  Enterprise-Researcher-Decentralized Clinical Trial Element Technology Developer signed a Letter of Intent(LOI) for Business Cooperation

• OCT.22

  Conversion of the Enterprise's own Physician Investigator, Clinical Research Associate, Clinical Research Coordinator, and Clinical Research Pharmacist certification system to a private qualification system

• OCT.12-14

  Hosted the 8th KoNECT International Conference (2022 KIC)

• OCT.06

  Signed a business agreement(MOU) with Dong-A ST for the introduction of new drugs not introduced in Korea

• SEP.30

  Designated as a public service corporation(donation organization)

• JUL.26

  Signed an agreement with HYUNDAI BIOSCIENCE to recruit participants and use a public platform for the phase 2 clinical trial for the development of a COVID-19 treatment

• JUN.09

  Launched Clinical Trial Digital Transformation Research Group

• MAY.20

  Hosted the 2022 Clinical Trials Day

• JAN.01

  Signed a contract with Korea University Guro Hospital to recruit participants for clinical trials for the development of a COVID-19 booster vaccine

2021

• DEC.29

  Won the Grand Prize for Web Award Korea 2021 in the field of research institute

• DEC.22

  Opened the Patient-Centered Clinical Trials Portal Service

• DEC.16

  Signed an MOU with the Korea Health Information Service

• NOV.16

  Launched a new integrated KoNECT website

• OCT.05-07

  Hosted the 7th KoNECT International Conference (2021 KIC)

• AUG.31

  Signed an agreement with the GeneOne Life Science to recruit participants for the phase 2a COVID-19 vaccine clinical trial and linked public platform

• AUG.24

  Signed an agreement with the SK bioscience to recruit participants for the phase 3 COVID-19 vaccine clinical trial and linked public platform

• AUG.20

  Started promotional campaign for national participation in COVID-19 vaccine clinical trial

• AUG.02

  Designated as Education Center for Regulatory Affairs Specialists (RA) in Medical Devices

• JUL.12

  Opened the Clinical Trial Participation Support Consultation Center

• MAY.20

  Hosted the 2021 International Clinical Trials Day

• MAY.10

  Organized the COVID-19 Vaccine Clinical Trial Support Task Force for participants recruitment and enrollment.

• APR.08

  Opened the Korea Clinical Trial Participation Platform (K-CLIC) Services

• MAR.05

  Opened the Clinical Trial Consulting Center for sponsors

2020

• NOV.10

  Opened the COVID-19 Clinical Trial Portal and held the joint signing ceremony for preclinical trial participation letter of intent

• SEP.22

  Designated as the National Infectious Diseases Clinical Trials Center and organized the Infectious Diseases Clinical Trial Center Consortium

• AUG.09

  Hosted the 6th KoNECT International Conference

• AUG.07

  Signed an MOU with the Korean Society of Infectious Diseases

• JUN.19

  Designated as APEC LSIF RHSC Training Center of Excellence (CoE) for Regulatory Science pilot for MRCT and GCP Inspections

• JUN.17

  Designated as an excellent joint training center by the Consortium for HRD Ability Magnified Program (CHAMP)

• JUN.12

  Signed an MOU with the Korean Association for the Study of the Liver

• MAY.28

  Established the National Clinical Trial Support Center

• MAR.02

  Designated as the official “Clinical Trial Support Center” under the Special Act on Fostering and Support of Pharmaceutical Industry

• JAN.20

  Appointed Byoung-jun, Bae as the 2nd Director of the Korea National Enterprise for Clinical Trials (KoNECT)

2019

• DEC.17

  Published the “Second Korean Clinical Trial White Paper”

• SEP.20

  Hosted the Korea Clinical Datathon 2019

• SEP.17

  Hosted the 5th KoNECT International Conference

• SEP.02

  Signed an MOU with the Korea Drug Research Association (KDRA)

• AUG.21

  Signed an MOU with Tigermed in China

• MAY.29

  Signed an MOU with the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA)

• MAY.17

  Held the 3rd International Clinical Trial Day Event with the government award for contribution to clinical trials

• APR.17

  Started the national campaign, “I Support Clinical Trials.”

• APR.01

  Signed an MOU with the Korea Association of Clinical Research Coordinator (KACRC)

• JAN.01

  Changed the institution's name to Korea National Enterprise for Clinical Trials (KoNECT)

2018

• NOV.02

  Hosted the Korea Clinical Datathon 2018

• OCT.31

  Hosted the 4th KONECT International Conference

• JUN.01

  Signed an MOU with the Asan Medical Center

• MAY.18

  Held the 2nd International Clinical Trial Day Event with the government award for contribution to clinical trials

• JUN.22

  Signed an MOU with Seoul National University Hospital/p>

• FEB.01

  Started the clinical development consulting (K-DREAM) program

2017

• DEC

  Started operation of Korea Clinical Trial Information Portal (K-CLIC)

• DEC.22

  Hosted the KoNECT Asia PK Network Workshop (participated by PMDA)

• DEC.16

  Signed an MOU with Korea Cancer Study Group

• NOV

  Conducted survey of clinical trial awareness for the general public and patients Published the “Korean Clinical Trial Industry Statistics”

• NOV.16

  Hosted the KoNECT Forum (New Drug Development Using Clinical Big Data)

• NOV.04

  Started the certification tests for clinical trial specialists

• NOV.01-03

  Hosted the 3rd KoNECT International Conference

• OCT.27

  Signed an MOU with the King Abdullah International Medical Research Center (KAIMRC) in Saudi Arabia

• OCT.01

  Appointed as the operating agency for CRO Self-Registration System (commissioned service by the Ministry of Food and Drug Safety)

• SEP.20

  Signed an MOU with the Translational Research Informatics Center (TRI) in Japan

• SEP.07-21

  Participated in the European Society for Medical Oncology Congress (ESMO, Spain)/World Congress of Neurology (WCN, Japan)

• AUG.17

  Hosted the Global New Drug Development Forum (quarterly)

• AUG.04

  Signed an MOU with Severance Hospital

• AUG

  Signed an MOU with Severance Hospital

• JUN.15

  Announced the execution of CRO institutional certification and consulting support project

• JUN.01-23

  Dispatched delegation to the American Society of Clinical Oncology (ASCO) and Drug Information Association (DIA)

• May.19

  Held the 1st International Clinical Trial Day Event with the government award for contribution to clinical trials

• May.15

  Hosted the KoNECT Regulatory Symposium

• APR.24-25

  Hosted the US FDA IND/NDA Training

• MAR.31

  Announced the execution of outbound support project for CRO

• MAR.20-24

  Participated in the Pharma Asia/Orphan Drug Conference in Singapore

• FEB.10

  Announced the execution of internship program for CRO

2016

• DEC

  Published the “Korean Clinical Trial White Paper”

• NOV.12

  Conducted the 6th certification test

• NOV.02-03

  Hosted the 2nd KoNECT International Conference

• OCT.20

  Signed an MOU with the Korean Society for Clinical Pharmacology and Therapeutics

• OCT.12-14

  Participated in Bio Japan and held a seminar

• OCT.12

  Conducted survey of clinical trial awareness for the general public and patients

• SEP.26-27

  Conducted special training for EMA regulations육

• SEP.09

  Held a meeting for revitalization of clinical trials

• AUG.16

  Started IRB form standardization study (jointly with KAIRB)

• AUG.16

  Executed CRO institutional certification and consulting support project

• JUN.26-30

  Dispatched delegation to DIA in the U.S. / Hosted KOREA DAY

• JUN.15

  Formed the gastric cancer network with 6 Asian countries

• JUN.03-06

  Dispatched delegation to ASCO in the U.S. / Hosted KOREA DAY

• MAY.12

  Signed an MOU with Korea University Anam Hospital

• APR.01

  Designated as the 1st educational institution for the Ministry of Food and Drug Safety's clinical trials

• MAR.29

  Held the opening ceremony of education center and workshops for partners

• MAR.28

  Executed the outbound support project for CRO

• JAN

  Analyzed the database of clinicaltrials.gov and provided regulatory information of 9 Asia countries

2015

• DEC.15

  Relocated the education center for clinical trial specialists (Chungjeongno→Gongdeok-dong KPX 6F)

• NOV.28

  Conducted the 5th certification test

• NOV.18

  Held the invitational briefing sessions for 6 companies including Senju Pharma, a pharmaceutical company in Japan

• NOV.04-05

  Hosted the 1st KoNECT International Conference

• NOV.02

  Opened the KoNECT Integrated Information System (KIIS)

• AUG.31

  Held the opening ceremony for KoNECT Collaboration Center

• JUN.14-18

  Participated in the North America Drug Information Association (DIA) and business partnering

• MAY.15

  15 Held the KoNECT-Kitasato University Joint International Cooperation Symposium

• MAY.01

  Started the Consortium for HRD Ability Magnified Program (CHAMP) project (Ministry of Employment and Labor)

• APR.09

  ECRIN(European Clinical Research Infrastructure Network)과 MOU 체결

• APR.01

  Established and started operation of the KoNECT Collaboration Center

• MAR.25

  Signed an MOU with the Korean Society for Clinical Development (KSCD)

• MAR.19

  Signed an MOU with the Ministry of Food and Drug Safety

2014

• DEC.20

  Executed the certification system for clinical trial specialists

• OCT.27

  Executed CRO institutional certification and consulting support project

• SEP.29

  Signed an MOU with the Drug Information Association (DIA)

• SEP.19

  Hosted the 1st Clinical Trial Specialist Workshop

• SEP.01

  Started research on “Korea Clinical Trials Global Initiative (KCGI)” (Professor Min Soo, Park of Yonsei University, Director of KCGI/research managing institute headquarters)

• JUL.08

  Started the education course for clinical trial specialists

• JUL.03

  Appointed as the Specialized Institution in Information Management for New Drug Development under the Special Act on Fostering and Support of Pharmaceutical Industry

• JUL.01

  Appointed members of the headquarters operation committee (2 subcommittees and 4 committees)

• JUL.01

  Started the commissioned service project “Support for the Establishment of Foundation for the Advancement of Clinical Trials” by the Ministry of Health and Welfare

• JUN.10

  Appointed the first head (Chairman Dong-hyun, Chee)

• MAY.09

  Prepared and relocated headquarters office

• MAR.25.

  Approved by the Ministry of Health and Welfare to establish a corporation

• JAN.24

  Held the KoNECT initiators meeting (Founder, Professor of Seoul National University College of Medicine, Sang-goo, Shin)

2013

• NOV

  Appointed the Global Clinical Trial Center (Severance Hospital and Inje University Pusan Paik Hospital)

2012

• NOV

  Appointed the Global Clinical Trial Center (Seoul National University Hospital and Asan Medical Center)

• FEB

  Executed the first clinical trial specialists certification system

2010

• OCT.05

  Appointed the regional clinical trial center (1 location other than Seoul)

• APR

  Integrated operation of 8 tasks for the Clinical Trial Professional Training Academy

2009

• AUG

  Executed pilot project for Clinical Trial Professional Internship program

• APR

  Selected additional 2 tasks for “Regional Clinical Trial Center” (1 in Seoul and 1 outside of Seoul)

2008

• MAY-SEP

  Selected 18 detailed tasks and 9 institutions for clinical trial specialists training academy support project

• MAY

  Selected additional 3 tasks for “Regional Clinical Trial Center” (2 in Seoul and 1 outside of Seoul)

2007

• DEC

  Appointed the director for the Korea National Enterprise for Clinical Trial (KoNECT) and started research on agreements/KoNECT

• NOV.14

  Deliberated the selection of the director for Policy Deliberative Committee for Health and Medical Service Technology

• OCT.10

  Announced the director

• OCT.09

  Deliberated the project plan for Policy Deliberative Committee for Health and Medical Service Technology

• JUL-SEP

  Prepared the Korea National Enterprise for Clinical Trial Transition Plan to secure international competitiveness in the Korean clinical trial field

• APR-JUL

  searched efficiency improvement of the regional clinical trial center program and operated the TF team for transition as an enterprise

• 02

  Established the Ministry of Health and Welfare R&D project improvement plan and Integrated the regional clinical trial centers (9 centers) and organized

2006

• MAY

  Selected 3 additional tasks for “Regional Clinical Trial Center” (2 in Seoul and 1 outside of Seoul)

2005

• MAY

  Selected 4 additional tasks for “Regional Clinical Trial Center” (1 for each region)

2004

• DEC

  Selected 2 additional centers for “Regional Clinical Trial Center” (1 in Seoul and 1 outside of Seoul)

• APR

  Conducted a research for Clinical Trial Based Support Project”