One stop full service Contract Research Organization

엘에스케이글로벌파마서비스

04535 서울특별시 중구 명동 퇴계로 97, 고려대연각빌딩 16층

Tel : 02. 546. 1008Fax : 02. 584. 9008E-mail : 견적문의 bd@lskglobal.com 일반문의 information@lskglobal.com

Website : www.lskglobal.com

02 03

LSK Global PS LSK Global PS

History2020 07 창사20주년기념“한국LeadingCRO의임상시험실무이해”발간 03 연세대학교의과대학강남세브란스병원과임상시험협력및연구성과위한MOU체결 02 ㈜엘에스케이글로벌파마서비스DataManagement대만지사(LSKTaiwan)설립2019 12 CRO최초부패방지경영시스템‘ISO37001’인증획득 06 국내CRO최초SCDM(SocietyforClinicalDataManagement)으로부터CCDM®(CertifiedClinicalDataManager)IndustryPartners로인증 05 LSKGlobalPS유럽(폴란드)연락사무소개설 02 ㈜메디포럼과치매치료제(PM012),2b/3상임상시험및공동연구개발MOU체결

신약개발자회사㈜엘에스케이엔알디오(LSKNRDO)설립

2018 03 임상연구수탁건수1,000건돌파2017 12 에빅스젠/메티메디제약과전략적제휴및투자계약체결 11 국내최초민간비임상시험기관인켐온과신약공동연구개발역량강화MOU체결 03 국내CRO업계최초임상시험서비스전분야‘ISO9001’인증획득2016 08 LSK교육센터,식약처임상시험등교육실시기관지정 06 국내CRO최초MedidataCTMS도입 04 ㈜엘에스케이에스엠오(LSKSMO)별도법인설립 03 LSKBioPharma와아파티닙(Apatinib)글로벌임상전략적제휴체결2015 10 오라클헬스사이언스인폼(OracleHealthSciencesInForm)도입 05 대표이사한국임상CRO협회초대회장 04 서울대학교병원임상시험센터와전략적파트너십체결2012 05 OutcomeResearchSeminar개최(서울,한국) 02 MultinationalClinicalResearchTrials&CDM개최(서울,한국)2011 09 AsiaCROAlliance구축 06 MedidataSolutions,Inc와ChannelPartner협약체결 03 고려대학교구로병원과임상시험협약체결2010 08 ElectronicDataCaptureService시작/Targete*StudioⓇ 07 LSKCDM연구개발실인증2009 11 단국대학교임상시험센터와협약체결2007 08 사명변경㈜라이프코드스텟코리아→㈜엘에스케이글로벌파마서비스2006 05 ACTN(AsiaClinicalTrialsNetwork)오픈 01 TargetHealthInc와ClinicalResearch&RegulatoryConsulting파트너십협약체결2001 12 Lifecord&Westat-Korea합병및사명변경“㈜라이프코드스텟코리아”2000 03 WestatKorea창립(미국WestatInc.한국지사)

LSK Global PS㈜엘에스케이글로벌파마서비스는2000년설립된국내최대통합임상시험수탁기관(CRO)으로

항암,심혈관계및내분비계를포함한다양한치료영역에특화된서비스를제공하고있습니다.

CRO의역할은물론신약개발파트너로서의다수의국내외제약사및글로벌CRO와의

파트너십을통해신약개발과임상시험을위한원스탑토탈솔루션(One-StopTotal

Solution)을제공해드리고있습니다.

다양한글로벌임상시험경험을통해축적된노하우와비용대비높은효율성,효과적인위기대처능력으로

기회비용을줄여고객만족도와신뢰도를높였습니다.또한안정화된시스템으로GlobalStandard수준의Quality로임상시험을

설계하고운영할수있는역량을갖추었습니다.

이러한역량을토대로㈜엘에스케이글로벌파마서비스는국내임상시험발전의중추적역할과대한민국제약산업의세계시장진출에

성공적파트너가되기위해노력해나갈것입니다.

아시아의중추적인글로벌CRO로써한국제약산업의글로벌시장진입에기여한다.

Vision

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.

04 05

LSK Global PS LSK Global PS

ExperienceLSKGlobalPS는설립(2,000년)이후글로벌기준을충족하는높은수준의효율적인임상시험서비스를제공한노하우와역량을

기반으로1,000건이상의다양한글로벌및국내임상시험을수행하였습니다.

연구유형별,치료군별로쌓아온다양한임상연구경험으로허가용임상시험과연구자주도임상시험,4상임상시험,PMS,관찰연구

등허가후임상을수행하고있습니다.

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

06 07

LSK Global PS LSK Global PS

Scope of 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

임상시험

계획 NDA 신청 재심사 신청시험 실시판매 후 조사

컨설팅프로토콜

개발

무작위

배정

증례

등록

모니터링

품질관리(QC)

감사(QA) 안전성 정기보고서 등 작성

안전성정보 안전성정보

증례

등록

데이터

관리

데이터

관리

통계

분석

통계

분석

결과 /

재심사

보고서

임상시험

결과

보고서

NDA

제출

재심사신청

서류작성IND 신청

NDA 승인·

판매(

허가)

재

심

사

One Stop Full Service

08 09

LSK Global PS LSK Global PS

Global Project Management

e-solution

LSKGlobalPS는다국적임상시험의경험과노하우를갖춘ProjectManager(PM)가고객과의One-stopcommunication으로

효과적인Projectmanagement서비스를제공하고있습니다.

FDA21CFRPart11의기준을충족하는최신의Solution을제공합니다.

SAS SoftwarePV SystemMedical Imaginag System

eTMF SystemCTMS SystemEDC System

신약개발의 효율적인 해외진출 Partner!

• 한국및한국외국가에서의효율적인비용과시간그리고고품질의1상,2상임상시험

•경쟁력있고효율성이높은3상임상시험

• 동남아시아국가에서의임상시험

• 아시아,미국,유럽의Globalnetwork를통한전략적인Global임상시험

Clinical Trial

Sponsor

Korea

Asia-Pacific

Europe

USA

Project Management

Strength

•ICH-GCP기반의SOP구축(영문,국문)

•FDA21CFRPart11의기준을충족하는시스템구축및운영(CO,DM,STAT,PV등)

•다수의글로벌CRO및국내외제약사의Systemaudit

•ISO9001:2015품질경영시스템인증(임상시험서비스전분야)

Global Standard Quality

•Global및Local임상시험경험을갖춘수준높은staff

•국내최대CertifiedStudyBuilder및CertifiedMedDRACoder인력보유

•국내유일EMAEudravigilanceICSR전자보고와XEVMPD에대한교육및평가완료자격을갖춘PV전문인력다수보유

•MedicalDoctor에의한medical모니터링및검토

•체계적이고전문적인직원교육

Specialized Human Resource

•1,000건이상의임상시험완료및진행

•다양한임상시험경험(global·local,large·small,early·latephase)

•다수의임상시험Rescue수행

•US-FDA와EMEA의Mock-Inspection경험

Extensive Experience

•우수한Study컨설팅

•highquality시험디자인

•축적된DB를통한연구준비시간단축

•전략적Projectmanagement및Sitemanagement

•원활하고효율적인One-StopCommunication

•신속한Issue분석및재발방지관리

Strategic Planning & Management

LSKGlobal PS

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

LSK Global PS LSK Global PS

1110

New York

North Carolina

Japan

TaiwanVietnam

Malaysia

Australia

Israel

Hungary

EstoniaNetherland

Japan

Asia CRO AllianceLSKGlobalPS는아시아를중심으로하는제약또는의료기기개발의글로벌확장을위하여한국의LSKGlobalPS,일본,베트남,

말레이시아,대만,필리핀의현지CRO들로구성된ACA(AsiaCROAlliance)를구축하였습니다.

ACA는각지역의요구사항및문화,관습에능통한현지CRO의네트워크로보다차별화된서비스제공이가능합니다.

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)

Global Network

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.

Europe(PV)HQ

India Taiwan(DM)

China