STRENGTHS

A 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

  • A CRO composed of professional manpower having the largest scale in Korea
  • The first CRO in Korea which has won a contract for First-In-Human (FIH, phase 1) clinical trials on anti-cancer drugs of global pharmaceutical companies
  • The first CRO in Korea which has completed the large scale phase 3 clinical trials on anti-cancer drugs conducted globally in more than 12 countries

INNOVATION

  • The first CRO in Korea which has constituted the PV Team and established a PV branch office in Europe
  • The first CRO in Korea which has established LSK NRDO Co., Ltd. and built up a proactive new drug pipeline based on the NRDO(No Research Development Only) business model

QUALITY

  • The first CRO providing a full-service in Korea which has been certified as a CCDM® (Certified Clinical Data Manager) Industry Partner
  • The first CRO which has acquired the ISO 9001:2015 certification for Quality Management Systems in the entire areas of services relevant with clinical trials
  • The first CRO which has acquired the ISO 37001 certification for Anti-Bribery Management Systems

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 surpassed 1,000 contracts for the conduct of clinical trials, and as of December, 2019, it had completed and was conducting more than1,100 clinical trials.

Cardiovascular 1 7% Oncology 1 7% Endocrinology 9% Others 9% 6% Neurology Vaccine Urology Gastroenterology Orthopedics Respiratory Hepatology Infectious Disease Ophthalmology Dermatology Rheumatology Psychiatry Medical Genetics ENT 1% Obstetrics and Gynecology 1% Blood system disorder 1% Pediatrics 1% Immunology 1% Nephrology 1% Plastic Surgery 1% Therapeutic Area 1,153 Projects (2000~2019.12)

* Others : Anesthesiology, Dental, Hematology, Rare Disease, General Surgery, 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 : CTM HQ 32.6%, Securement of QCRA Certification qualified by KoNECT (As of November, 2019) *QCRA test (Annual Qualification test for CRA sponsored 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.