One stop full service Contract Research Organization

Start with LSK Global PS97 Toegye-Ro, Coryo Daeyungak Tower 16th Fl,Jung-Gu, Seoul 04535 Korea

Main : +82. 2. 546. 1008Fax : +82. 2. 584. 9008E-mail : bd@lskglobal.com (for Estimation) information@lskglobal.com (for General inquiry)

Website : www.lskglobal.com

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LSK Global PS LSK Global PS

To become an Asia-centric global CRO that helps Korean pharmaceutical industry to expand into the global market.

LSK Global PS

Vision

Established in 2000, LSK Global Pharma Service Co., Ltd. is the largest One Stop Full Service contract research organization (CRO) in Korea. We provide services of a variety of therapeutic areas including oncology, cardiovascular, endocrinology, and etc.

Through various global clinical trial opportunities, we have developedpartnerships with many local and overseas pharmaceutical companies as well as global CROs and we have equipped ourselves with abilities to provide ‘One-Stop Total Solution’ for new drug development and clinical trials.

In abstract, improved cost effectiveness and reduced opportunity cost that we bring to our clients through our accumulated know-how, expertise and effective risk management are the basis for gaining client satisfaction for building business credibility.

We have successfully established a stable clinical trial management system through the experiences, capability of designing and operating clinical trials which meets global standard.

History2020 07 Published, “A Leading CRO, Understanding of Clinical Trial Practice” celebrating the 20th year anniversary 03 Execution of MOU with Gangnam Severance Hospital, Yonsei University for cooperation for clinical trials research 02 LSK Global PS Asia Branch (Taiwan) established2019 12 First CRO to acquire the ‘ISO 37001’certification for Anti-Bribery Management Systems for the entire service area. 06 Recognized as a Certified Clinical Data Manager (CCDM®) Industry Partner by Society for Clinical Data Management (SCDM) 05 LSK Global PS Europe Branch(Poland) established 02 Joint Research and Development with Mediforum for phase 2b/3 clinical trials for PM012

Established LSK NRDO(No Research Development Only) subsidiary 2018 03 Over 1,000 clinical research projects completed or ongoing2017 12 LSK Global PS & Avixgen, joint investment research and development

LSK Global PS & MetiMedi Pharmaceuticals, joint investment research and development 11 LSK Global PS & Chemon, Non-clinical Service CRO, MOU 03 First Korean CRO to Acquire ‘ISO 9001’ Certification for Clinical Trial Services 2016 08 LSK Education Center, Designated as an Education Center for Clinical Research by MFDS 06 Medidata CTMS service, first among CROs in Korea 04 LSK SMO established 03 Strategic Alliance for Apatinib global clinical trials with LSK BioPharma 2015 10 Oracle Health Sciences InForm Service 05 LSK CEO elected first chairperson of the Korean Association of Clinical CROs 04 Signed agreement with Seoul National University Hospital 2012 05 Seminar on “Outcome Research” (Seoul, Korea) 02 Seminar on “Multinational Clinical Research Trials & CDM” (Seoul, Korea)2011 09 Started Asia CRO Alliance 06 Started Medidata Soulutions Service 03 Signed Agreement with Korea Univ. Hospital2010 08 Electronic Data Capture Service with Target e*StudioⓇ 07 CDM Research and Development certification from KITA2009 11 Signed agreement with Dankook Univ. Hospital Clinical Trial Center2007 08 The company name was changed to LSK Global Pharma Services Co., Ltd.2006 05 Joined ACTN (Asia Clinical Trials Network) 01 Partnership with Target Health, Inc.2001 12 Lifecord and Westat-Korea merged to form Lifecord Stat-Korea, Inc.2000 03 Westat-Korea was established (Westat, Inc. Korea branch)

A Leading CRO in Asia-Pacific

Quality Oriented Full Service CRO

Technically Advanced CRO

Ethical & Transparent CRO

CRO Going Global with Competitive Service Delivery

A CRO withGlobal Ambition

Reliable CRO

World class Clinical Trial Service

Advancement of DomesticPharmaceutical Industry

into World Market

Organization

Update on Oct. 2020

Training Dept.

Training

PM Dept.

PMProject

Directors PS

CTM HQs

SSUCO QC

C&MC Dept.

C&MC RPA

QA Dept.

QA

CC Dept.

CC

MA Dept.

BDDept.

BD

BSDept.

BP BS

SCDept.

PD RA

BNS Vice President(CBO, CSO)

Senior Medical Advisor Oncology Director& Medical Monitor Executive Advisor

Executive Vice President(COO, CFO)

PVDept.

PV

ERDept.

ER

FADept.

FA

M&P Dept.

ADPL AC

CMDept.

CM

MW&RESDept.

MW&RES

STAT Dept.

STAT

CDM HQs

Dept.CDM

CDM DSM DQM DMS

ITDept.

IT

CSO

President

CO Dept.

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LSK Global PS LSK Global PS

ExperienceSince 2000, LSK Global PS has conducted over 1,000 global and domestic clinical research projects and accumulated enough expertise as well as capability to provide high-quality, cost effective clinical trial services that meet global standards.

LSK conducts all phases of interventional studies and variety of non-interventional studies including Investigator Initiated Trials, phase 4, PMS, observational studies, and etc.

Therapeutic Area

Oncology 16%

1,216 Projects(2000~2020.06)

Cardiovascular 16%

Endocrinology 9%

Neurology6%

Other10%

Vaccine4%

Urology 4%

1% Pediatrics

1% Plastic surgery

1% Immunology

1% ENT

1% Nephrology

1% Obstetrics/Gynecology

1% Blood system disorder

4% G

astro

ente

rolo

gy

3% Hepatology

3% Infection Disease

3% Respiratory

2% Medical Genetics

2% Rheumatology

2% Dermatology2% Psychiatry

2% Ophthalmology

Orthopedics 4%

Updated on June 2020 Updated in June 2020

Phase I 10%

Phase IV 4%

Phase II 25%

IIT 3%

PMS 1%

Observational Study 1%

Bridging Study 1%

Outcome Study 1%

Feasibility 1%

Phase III 43%

Consulting 5%

Other 5%

Global Study Total 136 studies

Phase I 16%

Phase IV 8%

Phase II 13%

IIT 4%

PMS 8%

Observational Study 6%

Research 2%

Health Food 1%

Bridging Study 1%

Medical Device 1%

Other 13%

Phase III 27%

Study Type Total 1,216studies

Phase I 24

Phase IV 1

Phase II 31

IIT 6

Bridging Study 1

Medical Device 1

Phase III 33

IND Study Total 97 studies

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LSK Global PS LSK Global PS

Scope of service

Clinical trial

PlanNDA

Application Post-Marketing surveillance Re-examination SubmissionConduct

Consulting ProtocolDevelopment

MonitoringQuality Control

Quality Assurance Re-examination annual report

Pharmacovigilance Pharmacovigilance

NDASubmission

Re-examination Submission

IND

Application

ND

A Approval·Sale

Re-Exam

ination

DrugAllocation

SubjectEnrollment

DataManagement

StatisticalAnalysis

ClinicalStudy

Report

SubjectEnrollment

DataManagement

StatisticalAnalysis

ResultReport

One Stop Full Service

Consulting

• Regulatory Strategy Consulting

• Bridging Study Strategy

• Study Design Consulting

• Product Development Consulting

• CMC Consulting

Project Management

• Milestone Management

• Risk Mitigation Plan

• Budget Management

• Vendor Management

Pharmacovigilance

• PV System Set-up & Management

• PSUR / PBRER Development

• RMP Development

• Literature Surveillance

• Safety Data Management

• Signal Detection

• PV SOP Wrting

Study Start-up

• Feasibility (Site / Investigator)

• IRB Submission

• CTA (Clinical Trial Agreement)

• PSSV

Biostatistics

• Sample Size calculation

• Randomization

• Statistical Analysis

• IDMC Support for Interim Analysis

• SAS Programing

• CDISC ADaM

• Data management

• Statistical Analysis

• Reporting

Medical Writing

• Protocol Development

• ICF Development

• CSR Writing

Medical Service

• Medical Consulting

• Target Product Profile

• Clinical Trial Design

Clinical Operation

• Monitoring (SIV, MV, COV, Query Resolution etc.)

• Documentation (Collection and Maintenance)

• Safety Management

• Site Management

• Quality Control

Quality Assurance

• Audit (Study, System, Vendor Qualification)

• SOP Development and Management

• Quality Management

Regulatory Affairs

• IND/NDA preparation& Submission

• IP/Non-IP Import Permit

• CMC Writing

• CTD Writing

• Bridging Exemption Report Writing

• Reimbursement Package /Submission

Data Management

• Data Management (EDC & Paper)

• CRF Development (Paper&e-Contents)

• Medical Coding

• CDISC SDTM/IWRS

• Data Sciences

PMS / Observational Studies

• Protocol & CRF development

• Project management

• Site management

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LSK Global PS LSK Global PS

Global Project Management

e-solution

Project Managers (PMs) are experienced in multinational clinical studies and are capable of providing excellent project management services through one-stop communication with customers.

We operate the latest solution that fulfill the requirements of FDA 21 CRF Part.

Partner for effective overseas expansion of pharmaceuticals!

• Cost-effective, timely and high quality phase 1&2 trials in Korea and outside of Korea

• Competitive and highly efficient pivotal clinical trials

• Clinical trials in South East Asia

• Strategic Global Clinical Trials through Global Network in Asia, USA and Europe

Clinical Trial

Sponsor

Korea

Asia-Pacific

Europe

USA

Project Management

Strength

• ICH-GCP Standard SOP (English, Korean)

• Globally accepted e-solutions for services of CO, DM, STAT, PV etc.

• Numerous assessment audits(Global CROs and pharmaceuticals)

• ISO 9001:2015 for overall clinical research services

Global Standard Quality

• High quality staffs with international and domestic study experiences

• Large number of Certified Study Builder and Certified MedDRA Coder in Korea

• Staffs qualified for EMA’s EudraVigilance ICSR electorinic reporting / training and evaluation of XEVMPD

• Medical Doctors for medical monitoring and review

• Systematic and professional staff training

Specialized Human Resource

• Over 1,000 projects completed or ongoing

• Various clinical trial experience (global∙local, large∙small, early∙late phase)

• Study rescue operation experience (over 10 projects)

• Mock-Inspection (US-FDA, EMEA)

Extensive Experience

• Study consulting expertize

• High quality study design

• Prompt study preparation by accumulated DB

• Strategic project management and site management

• Efficient and seamless One-Stop Communication

• Rapid issue analysis and CAPA management

Strategic Planning & Management

LSKGlobal PS

SAS SoftwarePV SystemMedical Imaginag System

eTMF SystemCTMS SystemEDC System

SAS Version 9.x BI Server,SAS Institute, NC, USA.

LSK Global PS LSK Global PS

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Asia CRO AllianceLSK Global PS provides services with the Asia CRO Alliance (ACA) for global expansion of parmaceuticals and medical devices.

The ACA is a unique and first-of-its-kind network that covers clinical investigations in the region of Asia.The ACA is comprised of the best CROs, all experts in local requirements, customs, and culture.

Global Network

Asia-Pacific

• Veras Research Japan, Ltd. (Japan)

• StatPlus, Inc. (Taiwan)

• Horus Co., Ltd. (Vietnam)

• MyXMO (Malaysia)

• MPI, Inc. (Tokyo, Japan)

• MakroCare Clinical Research, Ltd. (Andhra Pradesh, India)

• Southern Star Research (Sydney, Australia)

• CR Medicon (Nanjing, China)

Europe

• Julius Clinical Research (Zeist, Netherland)

• Cato Research Israel, Ltd. (Tel Aviv, Israel)

• Egeen International, Inc. (Eastern Europe)

• HungaroTrial (Budapest, Hungary)

USA

• Cato Research Durharm, Ltd. (North Carolina, USA)

• Medidata Solutions, Inc. (New York, USA)

• Target Health, Inc. (New York, USA) ACA Partner• (Australia] Southern Star Research

ACA CROs

• (Korea) LSK Global PS Co., Ltd. • (Japan) Veras Research Japan Ltd.• (Vietnam) Horus Co., Ltd.

• (Malaysia) MyXMO• (Taiwan) StatPlus, Inc.

New York

North Carolina

Japan

TaiwanVietnam

Malaysia

Australia

China

Israel

Hungary

EstoniaNetherland

Europe(PV)HQ

India Taiwan(DM)