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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 : [email protected] (for Estimation) [email protected] (for General inquiry)
Website : www.lskglobal.com
02 03
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.
04 05
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
06 07
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
08 09
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
1110
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)