HOMEA Leading CRO in Korea
As a leading CRO in Asia-Pacific representing Korea, LSK Global PS is taking the initiative for advancement of the domestic CROs and trying its best to help Korean pharmaceutical industry expand its scope into the global market.
CAPABILITY
- 400 Clinical Trial Experts providing One-Stop-Full-Service for new drug development
- 1620+ Clinical Trial Research Experience including 180+ Global Trials (As of June 2024)
- Global Network with ACA (Asia CRO Alliance) and Global Partners around the world
- First Korean CRO to conduct a multinational FiH (First in Human) oncology phase 1 study
- First Korean CRO to complete a large-scale global oncology phase 3 trial in 12 countries
INNOVATION
- First Korean CRO to have in-house PV(Pharmacovigilance) team and establishing a European branch for Pharmacovigilance service
- First Korean CRO to establish a Data Management Taiwan branch
- First Korean CRO to use remote clinical trial solution system
- The Big Data Part team employs RWD/RWE data to expand the scopes of new drug development
- The management of LSK Education Center focuses on delivering a systematic education program aimed at training industry associates to become clinical trial experts with a global perspective
QUALITY
- First Korean CRO to acquire Quality Management System ISO 9001:2015 certification for all clinical trial service areas
- First Korean CRO to be certified as CCDM® (Certified Clinical Data Manager) Industry Partner
- First Korean CRO to acquire Anti-Bribery Management System ISO 37001:2016 certification for corporate system management
- First Korean CRO to acquire Clinical Investigation of Medical Devices for Human Subjects ISO 14155:2020 certification for conducting medical device trials
- First Korean CRO to acquire Information Security Management Systems ISO/IEC 27001 : 2013 certification
- First Korean CRO with EMA pharmacovigilance information direct reporting qualified specialists
- Entire team of QA department with RQAP-GCP (Registered Quality Assurance Processionals in Good Clinical Practice) qualification
Provision of One-Stop Full Service for Entire Cycle of Clinical Trials LEARN MORE 
LSK Global PS provides the services for project management and clinical development at the highest level during the entire cycle of clinical trials through its great wealth of experience, support system, and infrastructure.
- Consultation on New Drug Development
- Conduct of Phase I-III Clinical Trials
- Conduct of Phase IV Clinical Trials and Post-Marketing Surveillances
Wide and Diverse Experiences in Clinical Trials LEARN MORE
As of March, 2018, LSK Global PS has been awarded more than 1,000 contracts for clinical trials projects, and has completed and or conducting more than 1,620 clinical trials as of June 2024.
* Others : Anesthesiology, Dental, Hematology, Antifungal Agent, General surgery, Angina pectoris, Consulting, etc.
Rescue of Multiple Clinical Trials
LSK Global PS has sufficient experiences and excellent competences that can lead clinical trials with diverse problems arising while conducted by pharmaceutical companies or other CROs to the right direction by resolving such problems. LSK Global PS has rescued more than 13 clinical trials in the various fields including Quality Control & Audit, Data Management, Statistical Analysis, Clinical Operation, and Pharmacovigilance.
Asia Centric Global CRO
Global Standard Quality Services
The excellence possessed by LSK Global PS in the development and management of clinical trials has been verified through the repeated audits by multiple domestic and foreign pharmaceutical companies and global CROs, and the inspections by the Korea Ministry of Food and Drug Safety.
LSK Global PS has gained recognition for its excellent services to the entire areas of clinical trials by becoming the first CRO in Korea which acquired the certification
for ‘ISO (International Organization for Standardization) 9001:2015’ Quality Management Systems in March 2017.
Capacity for conducting Global Clinical Trials
LSK Global PS has been conducting more than 130 global clinical trials and successfully completed a huge scale clinical trial conducted globally at over 95 study centers in 12 countries of Europe and Asia as well as USA for the first time in Korea.
Construction of Infrastructure for Global Clinical Trials
LSK Global PS has established a customized process for global clinical trials by grasping changing rules and regulations of the foreign regulatory authorities and introducing the systems suitable for global standards.
LSK Global PS provides the optimized solutions to help global clinical trials to be successfully conducted by establishing customized strategies for the licensing regulations of individual countries with the help of regulatory experts from its global partner CROs.
Global Project Management
The project managers having diverse experiences in global clinical trials accede to the requests from clients in a prompt and precise manner and systematically manage the partner CRO of each country.
Specialized Human Resource
“Experienced Resource”
LSK Global PS provides high-quality clinical trial outputs through the manpower possessing experiences and know-hows accumulated in the individual fields of clinical trials including global ones for more than 10 years.
“Certified Resource”
- Certified Programmer for the Java
- Certified Engineer for Information Processing
- Certified Study builder and System Administrator for Rave®
- Certified Clinical Data Manager(CCDM®) by SCDM
- Certified Medical Coder(MedDRA)
- SAS® Certified Advanced Programmer
- PV Staffs Qualified for EMA’s EudraVigilance ICSR electronic reporting and trained and evaluated for XEVMPD
- RQAP-GCP(Registered Quality Assurance Professional in Good Clinical Practices)
- Certified QCRA (Qualified Clinical Research Associate) *QCRA(Qualified Clinical Research Associate) exam (CRA qualification exam per year, provided by KoNECT)
“Medical Monitor”
LSK Global PS reviews the problems that may arise in clinical trials through the medical monitoring performed by medical doctors of various fields.
