2019 ClinActis Overview

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

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
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
Value
25

90+ 30+500+
Clinical Projects Clinical Sites Sponsors
Basic Facts

0 0
Zero 483’s
Warning Letters
Quality Through Managed Growth – When ‘Zero’ Matters
Zero Enrolments
Missed

■ Strategic Consulting
■ Regulatory Support
■ Medical Writing
■ Logistics
■ Pharmacovigilance
■ Quality Assurance
■ Project Management
■ Monitoring
■ Data Management
■ Biostatistics
Services

180days
42days
60days
90days
120days
Hong Kong
Korea
ThailandTaiwan
Japan
Singapore
Malaysia
New Zealand
365days
China
Australia = Notification only
Philippines
Vietnam
India
Indonesia
Regulatory Approval Timelines

2019 Award

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
Founder & CEO

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
Asian Based

■ 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
Mission and Vision

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
Value Proposition

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
Clinical Research Professionals

Experience

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
Experience

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
Oncology Experience

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
Other Therapeutic Experience

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
Other Therapeutic Experience (Continued)

Summary

■ 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
Advantage

2019 ClinActis Overview

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