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2019 ClinActis Overview

ClinActis Pte Ltd
ClinActis Pte Ltd
ClinActis Pte LtdClinActis Pte Ltd

ClinActis Pte Ltd is a Clinical Research Organization specialized in Asia Pacific, providing pharmaceutical, medical device, medical nutrition and biotech companies with state of the art clinical research services with an approach fully customized to the specificities of Asia Pacific. Our regional coverage includes Singapore, Malaysia, Thailand, The Philippines, Vietnam, Indonesia, Taiwan, Hong Kong, Korea and Australia, as well as India through our strategic alliance with an Indian CRO.

2019 ClinActis Overview

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Corporate Overview
ClinActis Pte Ltd - 112 Robinson Road - #06-04 - Singapore 068902 Telephone: +65 6436 5500 - info@clinactis.com
■ Full service CRO providing
clinical trial services to the
pharmaceutical, medical
device, medical nutrition and
biotech companies in Asia
Pacific.
■ Established in 2009.
■ Headquartered in Singapore.
ClinActis Pte Ltd
■ Multicultural company. As
such, the team is able to
communicate effectively with
international clients.
■ Exclusively focused on Asia
Pacific, with solid expertise in
applying international quality
standards to regional
specificities.
■ Flexible in our approach to
work scope and budgeting
and contracting process
Value Proposition
■ Committed to implementing
international standards in
clinical trials.
■ Ability to deliver high quality
results to our clients is based
on recruiting and maintaining
the best talent within our
organization.
■ ClinActis’ senior management
is fully accountable for the
quality of deliverables to our
clients.
Delivering Quality
About Us
ClinActis Pte Ltd - 112 Robinson Road - #06-04 - Singapore 068902 Telephone: +65 6436 5500 - info@clinactis.com
n HQ:
Singapore
n Branch Offices/Affiliates:
Korea, Taiwan, Hong Kong,
Malaysia, Philippines
n Local Presence:
Thailand, Indonesia, Vietnam,
Australia/New Zealand, China
n Partner:
India, Japan
●Singapore
Thailand
Malaysia
Taiwan
The Philippines
Hong Kong
Vietnam
Korea
Japan
Indonesia
India
China
Australia
New Zealand
ClinActis Pte Ltd - 112 Robinson Road - #06-04 - Singapore 068902 Telephone: +65 6436 5500 - info@clinactis.com
Geographic Coverage
Unique Geography
(Asia Pacific)
Well Established
Quality Management
System
Quick Start-up
(2-6 months)
FDA / EMA
Acceptable Data
System Audits
by Sponsors
ClinActis Pte Ltd - 112 Robinson Road - #06-04 - Singapore 068902 Telephone: +65 6436 5500 - info@clinactis.com
Value
25
90+ 30+500+
Clinical Projects Clinical Sites Sponsors
ClinActis Pte Ltd - 112 Robinson Road - #06-04 - Singapore 068902 Telephone: +65 6436 5500 - info@clinactis.com
Basic Facts
0 0
Zero 483’s
Warning Letters
ClinActis Pte Ltd - 112 Robinson Road - #06-04 - Singapore 068902 Telephone: +65 6436 5500 - info@clinactis.com
Quality Through Managed Growth – When ‘Zero’ Matters
Zero Enrolments
Missed
Ad

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2019 ClinActis Overview

  • 1. Corporate Overview ClinActis Pte Ltd - 112 Robinson Road - #06-04 - Singapore 068902 Telephone: +65 6436 5500 - info@clinactis.com
  • 2. ■ Full service CRO providing clinical trial services to the pharmaceutical, medical device, medical nutrition and biotech companies in Asia Pacific. ■ Established in 2009. ■ Headquartered in Singapore. ClinActis Pte Ltd ■ Multicultural company. As such, the team is able to communicate effectively with international clients. ■ Exclusively focused on Asia Pacific, with solid expertise in applying international quality standards to regional specificities. ■ Flexible in our approach to work scope and budgeting and contracting process Value Proposition ■ Committed to implementing international standards in clinical trials. ■ Ability to deliver high quality results to our clients is based on recruiting and maintaining the best talent within our organization. ■ ClinActis’ senior management is fully accountable for the quality of deliverables to our clients. Delivering Quality About Us ClinActis Pte Ltd - 112 Robinson Road - #06-04 - Singapore 068902 Telephone: +65 6436 5500 - info@clinactis.com
  • 3. n HQ: Singapore n Branch Offices/Affiliates: Korea, Taiwan, Hong Kong, Malaysia, Philippines n Local Presence: Thailand, Indonesia, Vietnam, Australia/New Zealand, China n Partner: India, Japan ●Singapore Thailand Malaysia Taiwan The Philippines Hong Kong Vietnam Korea Japan Indonesia India China Australia New Zealand ClinActis Pte Ltd - 112 Robinson Road - #06-04 - Singapore 068902 Telephone: +65 6436 5500 - info@clinactis.com Geographic Coverage
  • 4. Unique Geography (Asia Pacific) Well Established Quality Management System Quick Start-up (2-6 months) FDA / EMA Acceptable Data System Audits by Sponsors ClinActis Pte Ltd - 112 Robinson Road - #06-04 - Singapore 068902 Telephone: +65 6436 5500 - info@clinactis.com Value 25
  • 5. 90+ 30+500+ Clinical Projects Clinical Sites Sponsors ClinActis Pte Ltd - 112 Robinson Road - #06-04 - Singapore 068902 Telephone: +65 6436 5500 - info@clinactis.com Basic Facts
  • 6. 0 0 Zero 483’s Warning Letters ClinActis Pte Ltd - 112 Robinson Road - #06-04 - Singapore 068902 Telephone: +65 6436 5500 - info@clinactis.com Quality Through Managed Growth – When ‘Zero’ Matters Zero Enrolments Missed
  • 7. ■ Strategic Consulting ■ Regulatory Support ■ Medical Writing ■ Logistics ■ Pharmacovigilance ■ Quality Assurance ■ Project Management ■ Monitoring ■ Data Management ■ Biostatistics ClinActis Pte Ltd - 112 Robinson Road - #06-04 - Singapore 068902 Telephone: +65 6436 5500 - info@clinactis.com Services
  • 8. 180days 42days 60days 90days 120days Hong Kong Korea ThailandTaiwan Japan Singapore Malaysia New Zealand 365days China Australia = Notification only Philippines Vietnam India Indonesia ClinActis Pte Ltd - 112 Robinson Road - #06-04 - Singapore 068902 Telephone: +65 6436 5500 - info@clinactis.com Regulatory Approval Timelines
  • 9. ClinActis Pte Ltd - 112 Robinson Road - #06-04 - Singapore 068902 Telephone: +65 6436 5500 - info@clinactis.com 2019 Award
  • 10. Christophe Tournerie, MD – Founder & CEO Dr. Tournerie has more than 20+ years experience in clinical research in Europe and Asia Pacific including Japan, working with biotechnology companies, pharmaceutical companies and clinical research organizations. After completion of his medical studies in Paris and various hospital assignments in France, Dr. Tournerie spent a period of 3 years at the National Medical Research Institute in France in the field of drug development in anti-HIV products. His introduction to the pharmaceutical industry was as Medical Director in an American biotechnology company developing anti-HIV products. Then, he moved to a large global CRO, heading the Project management Department for South Europe, and then as Head of Operations in the Japan affiliate. Later, Dr. Tournerie headed the Asian clinical research activity for a multi-national Pharmaceutical Company, based in Singapore. More recently, Dr. Tournerie was Vice President Asia Pacific for a large global CRO, based in Singapore. During this assignment, Dr. Tournerie developed the business strategy for the region, successfully established and directed operations in 12 countries and built a highly professional team. Christophe Tournerie, MD Founder & CEO ClinActis Pte Ltd - 112 Robinson Road - #06-04 - Singapore 068902 Telephone: +65 6436 5500 - info@clinactis.com Founder & CEO
  • 11. Global CROs: Large organizations Solid Infrastructure International quality standards BUT Lack of understanding of Asia specificities Lack of flexibility Higher costs Local CROs: Proximity to market Flexible Lower costs BUT Uncertain quality standards No full Asia regional coverage GAP A CRO Specialized in Asia Pacific, Site Networks, Knowledge of Patient Populations, with Flexibility, Lower Costs, at International Quality Standards Market Opportunity: Significant Gap in Current CRO Offering ClinActis Pte Ltd - 112 Robinson Road - #06-04 - Singapore 068902 Telephone: +65 6436 5500 - info@clinactis.com Asian Based
  • 12. ■ To provide a unique and dynamic expertise while applying global drug development standards to the specificities of each country in the Asia Pacific region. ■ To become the reference (FSP) CRO specialized in conducting clinical research in Asia Pacific, offering state of the art quality services, with cost effective solutions. Mission Vision ClinActis Pte Ltd - 112 Robinson Road - #06-04 - Singapore 068902 Telephone: +65 6436 5500 - info@clinactis.com Mission and Vision
  • 13. Extra Attention Flexibility Senior Management Experience § In-Country Regulatory Relationships § Senior Management Insight & Input § Additional visits § Additional negotiation of on-site budgets § Library of Site contracts by Country § Access to Patient Databases § Singapore HQ § Senior Management based in the region and accountable for deliverables § Regional PM knowledge of region wide sensitivities § More senior CRAs/PMs § CRAs located locally in each Country § Consistent Standards § Centralised Knowledge § Scope of work, budgeting & contracting § Adaptability: Experience amending operating structure if it will create better outcomes. § Tailoring specific services § Creating new roles for the benefit of a study § Country specific rates § Accessibility Solid Operating Structure § CEO & Director of Operations have combined 40+ years of personal experience setting up and running operations in all major countries in the region § Extensive knowledge of regulatory frameworks, best KOLs and sites across the region based on ICH/GCP compliance and audits ClinActis Pte Ltd - 112 Robinson Road - #06-04 - Singapore 068902 Telephone: +65 6436 5500 - info@clinactis.com Value Proposition
  • 14. CRITERIA § Locally Based § Full Time § Global and Local Experience § Both Biotech and CRO Experience § ICH/GCP Trained MOTIVATIONS § Asian Company for Asia § Traditional Model § Experiences To Be Gained § Management In Singapore § Flexible § Scientist Rather Than Admin Role QUALITY § Senior Management Fully Accountable for Deliverables § Quality Control Process § Senior Management Insight & Input § International Influence TRAINING § Senior Management = Mentors § ‘On-The-Job’ Training § Varied, Multi-Tasking Environment § QC and Co-Monitoring = Consistent Standards Highly Experienced High Retention Rates Added Expertise Continued Development ClinActis Pte Ltd - 112 Robinson Road - #06-04 - Singapore 068902 Telephone: +65 6436 5500 - info@clinactis.com Clinical Research Professionals
  • 15. Experience ClinActis Pte Ltd - 112 Robinson Road - #06-04 - Singapore 068902 Telephone: +65 6436 5500 - info@clinactis.com
  • 16. I 16% II 8%IIa 3% IIa/IIb 3% III 40% III/IV 3% IV 19% Registry 8% ■ Oncology (50%) ■ Neurology/CNS (25%) ■ Infectious Disease (15%) ■ Inflammation (70%) ■ Respiratory (10%) ■ Renal (5%) ■ Haematology (5%) ■ Vaccines (10%) ■ Endocrinology (2%) ■ Cardiovascular (5%) ■ Ophthalmology (10%) Therapeutic Areas ■ Urology (5%) ■ Gastroenterology (20%) ■ Nutrition (5%) ■ Dermatology (5%) ■ Cosmetics (2%) ■ Surgery (2%) ■ Trauma (2%) ■ Allergy/Immunology (10%) ■ Autoimmune (30%) ■ Medical Device (5%) Study Phases ClinActis Pte Ltd - 112 Robinson Road - #06-04 - Singapore 068902 Telephone: +65 6436 5500 - info@clinactis.com Experience
  • 17. Indication Study Design Study Phase # Sites # Patients Location Responsibilities Client (Blinded) T-cell Lymphoma Open-label III 35 80 SG, HK, KR, TW, PH, MY, TH PM, Reg, Monitoring EU Pharma GIST Double-blind III 40 180 SG, HK, KR, TW, PH, MY, TH PM, Reg, Monitoring EU Pharma Prostate Cancer Double-blind III 45 130 SG, HK, KR, TW, PH, MY, TH PM, Reg, Monitoring EU Pharma Pancreatic Cancer Double-blind III 33 90 SG, HK, KR, TW, PH, MY, TH PM, Reg, Monitoring EU Pharma Colorectal Cancer Double-blind III 38 124 SG, HK, KR, TW, PH, MY, TH PM, Reg, Monitoring EU Pharma Colorectal Cancer Open-label III 21 100 SG, HK, KR, TW, PH, MY, TH PM, Reg, Monitoring EU Pharma Esophago-gastric adenocarcinoma Double-blind III 16 140 HK, KR, MY, PH, TH PM, Reg, Monitoring EU Pharma Melanoma Open-label III 30 75 SG, HK, KR, TW, PH, MY, TH PM, Reg, Monitoring EU Pharma Hepato cellular carcinoma Open-label III 28 110 SG, HK, KR, TW, PH, MY, TH PM, Reg, Monitoring EU Pharma Breast Cancer Double-blind II 2 8 SG Monitoring EU NGO Pleural Mesothelioma Double-blind II 3 12 KR Reg, Monitoring US Biotech Epithelial Cancers Open-label l 1 12 SG Monitoring US Biotech ClinActis Pte Ltd - 112 Robinson Road - #06-04 - Singapore 068902 Telephone: +65 6436 5500 - info@clinactis.com Oncology Experience
  • 18. ClinActis Pte Ltd - 112 Robinson Road - #06-04 - Singapore 068902 Telephone: +65 6436 5500 - info@clinactis.com Therapeutic Area Study Phase # Sites # Patients Location Activity Client Obstetrical / Unripe Cervix II 13 360 SG, HK, TH PM, Reg, Monitoring EU Biotech Ophthalmology IV 1 20 SG Monitoring Gov’t Agency Regenerative Medicine (Cardiology) Pilot 1 10 SG Reg, Monitoring EU Biotech Chronic HBV Infection I 5 20 SG, KR PM, Reg, Monitoring US Biotech Dysfunctional AV Fistulae Med Device PMS 6 60 SG, TW PM, Reg, Monitoring EU Med Device Asthma III 50 150 SG, HK, KR, TW, PH, MY, TH PM, Reg, Monitoring EU Pharma CNS (ALS) III 15 20 SG, HK, KR, TW, PH, MY, TH PM, Reg, Monitoring EU Pharma Progressive Supra-Nuclear Palsy III 20 30 SG, HK, KR, TW, PH, MY, TH PM, Reg, Monitoring EU Pharma Multiple Sclerosis III 30 80 SG, HK, KR, TW, PH, MY, TH PM, Reg, Monitoring EU Pharma Vaccine (Rabies) I 1 30 SG PM, Monitoring, DM, CSR Regional Pharma Ophthalmology IV 1 250 PH Monitoring US Pharma Vaccine (HBV) I 1 30 SG PM, Monitoring, DM, CSR Regional Pharma Rheumatoid Arthritis III 17 50 SG, TW, KR, PH, MY PM, Reg, Monitoring EU Pharma Severe Asthma III 21 150 KR, PH, TW, MY, TH PM, Reg, Monitoring EU Pharma ClinActis Pte Ltd - 112 Robinson Road - #06-04 - Singapore 068902 Telephone: +65 6436 5500 - info@clinactis.com Other Therapeutic Experience
  • 19. Therapeutic Area Study Phase # Sites # Patients Location Activity Client Dermatology IV 3 50 SG Full Service (Protocol to Manuscript) Regional Pharma Hematology Registry 15 150 MY, TH PM, Reg, Monitoring EU Pharma Neurology III/ IV 12 216 AU, SG, HK, PH PM, Reg, Monitoring EU Pharma Nutrition III 1 153 SG PM, Startup, Monitoring Global Nutrition Diabetes Registry 18 175 SG PM, Reg, Monitoring Global Pharma Infectious Disease I 1 16 SG PM, Reg, Monitoring EU Biotech Infant Colic III 7 103 AU, SG, India, TH, TW PM, Reg, Monitoring EU Pharma Alzheimer’s disease III 15 202 KR, TW, SG, MY, PH, HK PM, Reg, Monitoring EU Pharma Dermatology IV 4 90 SG Startup/ Manuscript Global Pharma Nutrition IIb 2 142 SG Startup Global Nutrition Nutrition IV 1 161 SG PM. Monitoring Global Nutrition Multiple Sclerosis I 1 18 SG PM, Reg, Monitoring EU Biotech Hematology I 1 48 SG PM, Reg, Monitoring EU Biotech Allergic Rhinitis I 1 20 SG Startup, Monitoring US Pharma ClinActis Pte Ltd - 112 Robinson Road - #06-04 - Singapore 068902 Telephone: +65 6436 5500 - info@clinactis.com Other Therapeutic Experience (Continued)
  • 20. Summary ClinActis Pte Ltd - 112 Robinson Road - #06-04 - Singapore 068902 Telephone: +65 6436 5500 - info@clinactis.com
  • 21. ■ Specialized and Focused solely on Asia Pacific; ■ Proven track record of expediting start-up (90-120 days) ahead of other regions; – Majority of Studies (Global and Pivotal for FDA and EMEA filings) – Huge Patient Population (100% recruitment attainment) – Extensive Library of Site contracts ■ Senior Management based in Singapore (Pharmaceutical/Biotech/CRO Hub in APAC) to provide local oversight; ■ Flexibility: model, scope of work, budgeting and contracting; ■ Highly experienced and Trained CRAs with International experience; ■ Low Turnover rate <5% ■ 100% of ClinActis CRAs have experience in Oncology, 80% have experience in Cardiovascular and 50% in Diabetes; ■ Extensive Networks of ICH/GCP Compliant Sites throughout APAC ■ Senior Management have extensive experience leading multiple Global Pivotal studies in Oncology, Infectious Disease, CNS and Cardiovascular studies across Asia Pacific The ClinActis Advantage ClinActis Pte Ltd - 112 Robinson Road - #06-04 - Singapore 068902 Telephone: +65 6436 5500 - info@clinactis.com Advantage