LSK Global PS

A CRO with Global Ambition

Reliable CRO
Technically
Advanced CRO
Ethical &
Transparent CRO
CRO going Global with
Competitive Service Delivery
Quality Oriented
Full Service CRO

LSK Global PS, a leading CRO in Asia Pacific Total solution to Successful New Drug Development from Consulting to Clinical Trials

LSK Global PS contributes to the entry of domestic pharmaceutical industry into the global market with competitiveness and expertise

As the first CRO in Korea which has successfully conducted clinical trials for new drug development on a global level, LSK Global PS provides a clinical research service competitive with the qualities satisfying the regulatory requirements of US and Europe.

STRENGTHS

The best CRO in Asia Pacific reliable in its diverse experiences and competence in global clinical trials
A Leading CRO
in Korea

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Provision of One-Stop Full Service for Entire Cycle of Clinical Trials

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Wide and Diverse
Experiences in Clinical Trials

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Asia centric
Global CRO

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Specialized
Human Resource

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Consulting Service

LSK Global PS has expertise and experience required for the development lifecycle starting from the establishment of initial development strategy to the strategies for CMC, preclinical study, clinical study, IND/NDA, etc. in the development of medical technology including new drugs.

Medical Service

For medical affairs, 3 medical specialists provide advices on what need to be considered from medical point of view during the phase of establishing strategies and plans for developing new drugs and technologies. They suggest and review the target patient population, study design, and evaluation variables during the preparatory phase for clinical trials in parallel with providing answers to medical inquiries and evaluating safety during each study period.

Medical Writing

LSK Global PS develops and provides ethical and scientific protocols for various studies including phase 1∼4 clinical studies on medicinal products and clinical studies on medical devices, human studies of health functional foods, observational studies, and post-marketing surveillances. After a clinical study is completed, LSK Global PS also prepares the clinical study report including the considerations on its statistical analysis results and clinical implications.

Regulatory Affairs

In LSK Global PS, RA experts are performing tasks to facilitate the conduct of clinical studies and the registration of products in a prompt and efficient manner throughout the entire development process of medical technologies including medicinal products by understanding the domestic and foreign regulations thoroughly and applying them harmoniously.

Project Management

LSK Global PS coordinates a clinical study as a whole and leads the entire teams as requested by a client by contemplating the project management plan and establishing the schemes for detailed project management, timeline management, quality management, risk management, and vendor management.

Study Start-Up

LSK Global PS helps to advance the project schedule by simultaneously mobilizing manpower specialized in the fields of project management, site start up, and clinical research operation to manage the time in the preparatory phase prior to start up a study efficiently.

Clinical Operation

LSK Global PS performs the tasks of overall site management including the per-study visit, initiation visit, regular monitoring, and close-out visit. Through the monitoring, LSK Global PS ensures as the top priority the clinical study is properly conducted in compliance with the relevant regulations, SOPs, and protocol, and performs periodic quality control to increase the completeness and accuracy of the collected data.

Data Management

LSK Global PS provides a full service for the data management regarding the configuration, operation, and management of the CDM system, starting from the development of the CRF(Case Report Form). Based on the data management experiences in various therapeutic areas, LSK Global PS provides efficient and specialized services in the collection and management of the clinical data obtained from Phase I~IV studies, OS(Observational Study), IIT(Investigator Initiated Trial), and PMS(Post-Marketing Surveillance).

Biostatistics

LSK Global PS analyzes the data and produces an appropriate assessment of the efficacy and safety based on the extensive knowledge and experiences of the experts in the field of biostatistics. LSK Global PS provides the comprehensive services beginning with the establishment of the statistical analysis plan reaching the analyses of data, preparation of outputs conforming to the CDISC standards, preparation of analysis reports, and consultation on statistics. LSK Global PS has wide experiences in the statistical analyses of diverse clinical researches and post-marketing surveillances as wells as clinical trials.

Epidemiological Research for PMS / OS

LSK Global PS has been providing professional services for the entire process of the post-marketing observational study including the rPMS(regulatory Post-Marketing Surveillance/reexamination study), observational study(prospective and retrospective studies), and survey by establishing a department dedicated to the tasks for epidemiological research in 2010.

Pharmacovigilance

As a domestic CRO, LSK Global PS is providing the pharmacovigilance services of managing the safety information on pre- and post-marketing medicinal products, medical devices, etc. Through organization of the department specialized in pharmacovigilance for the first time.

Quality Assurance

LSK Global PS performs independent audits and internal quality management in compliance with the ICH-GCP. LSK Global PS provides audits based on the ICH-GCP and consulting service built on the experiences in the audits of a lot of domestic/foreign pharmaceutical companies and CROs, and the inspections by the regulatory authorities. In addition, LSK Global PS is providing services for the development of standard operating procedures(SOPs) complying with the ICH-GCP and domestic laws/regulations, consultation, and vendor assessment.

Academic Research Service

Academic Research Service(ARS) provides the best quality service from research planning, development to publication based on scientific integrity that complies with global standards

Training

LSK Global PS has been running a systematic education program for the employees involved in clinical studies including monitors for more than 10 years. LSK Global PS is staffed with the instructors having rich experience in clinical studies and has the advantage of providing education closely related with the practical works along with the ethics and basic understanding of clinical studies.

EXPERIENCES

LSK Global PS is providing efficient clinical service of high-quality satisfying the global standard.

1620+

TOTAL
180+

GLOBAL
145+

IND
265+

ONCOLOGY
16+

RESCUE

NEWSROOM

NETWORK

Education Center

LSK Global PS is running a training to develop the professional manpower on the global level.

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