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.

1. Your Proactive Clinical Research
Partner in Asia Pacific

2. Asia Pacific, the Growth Force
Economic growth remains strong in Asia Pacific markets
despite the economic crisis.
The pharmaceutical market in Asia is growing at 10-15% in
Asia compared to 5-7% in G7 countries (source: Price
Waterhouse Coopers).
Good Clinical Trial Infrastructure in the Region
There is continuous growth in the scientific base and
capabilities in Asia, encouraged by local authorities, given the
growing contribution of clinical research to the local economy.
There are centralized healthcare institutions, well qualified,
highly motivated investigators and excellent clinical trial
facilities which are comparable to the best in class globally.
Trials are supported by clinical trial units and study
coordinators.
Efficient Regulatory and Ethics Committee Processes
With the appropriate approach, the regulatory approval
processes in most Asia is no more complex than in the US or
Europe, with the exception of China where it is still relatively
complex and require long timelines.
Overview of Clinical Research in Asia Pacific
The trend is among the regulatory authorities within the
region is towards reduction of regulatory approval timelines.
Regulatory agencies in several countries do provide clear
instructions on their processes and requirements for
documentation. Most agencies provide this information on
their websites which are updated regularly to include the
latest requirements and policies.
All regulatory agencies are well organized and welcome
meetings with sponsors as necessary to facilitate the
submission and review process.
The majority of healthcare institutions have well organized
Ethics Committees (EC) / Institutional Review Boards (IRBs)
which follow ICH GCP and have now acquired significant
experience.

3. Market Opportunity: Significant Gap in
Current CRO Offering
Successful Study Delivery
with
Cost efficiency
High Quality
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,
with flexibility, lower costs, at
international quality standards

4. Value Proposition
Extra Attention Flexibility
Senior
Management
Experience
• Regulatory
Relationships
• Senior Management
Insight & Input
• Additional visits
• Additional
negotiation of on-
site budgets
• Singapore HQ
• Senior Management
based in the region and
accountable for
deliverables
• Regional PM knowledge
of region wide
sensitivities
• More senior CRAs/PMs
• Consistent Standards
• Centralised Knowledge
• CEO & Director of
Operations have
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
• 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

5. Geographic Coverage
5
n HQ:
Singapore
n Branch offices/Affiliates:
Korea, Taiwan, Hong Kong,
Malaysia, Philippines
n Local presence:
Thailand, Indonesia, Vietnam,
Australia
n Partner:
India

6. ■ Strategic Consulting
■ Conduct Ph I & II Studies
■ Clinical Trial Design
■ Protocol Development
■ Regulatory Guidance and Planning
■ Regulatory Agency Representation
■ Submission Planning
■ Site Feasibility, Selection
■ Statistical Analysis Plan
■ Safety Reconciliation
■ Database Lock
■ CSR Production
Core Services
■ Strategic Consulting
■ Plan and conduct Ph III & IV Studies
■ Interim Analysis in Pivotal Trials
■ Regulatory Guidance and Planning
■ Regulatory Agency Representation
■ Submission Planning
■ eCRF Database Development
■ Statistical Analysis Plan
■ Safety Reconciliation
■ Database Lock
■ CSR Production
Phase I & II Phase III & IV

7. ClinActis Clinical Research Professionals
• Senior Management = mentors
• 'On-Job' training
• Varied, multi-tasking environment
• QC and Co-monitoring = consistent
standards
• Senior Management Fully
Accountable for Deliverables
• Quality Control Processes
• Senior Management Insight &
Input
• International Influence
• Asia Company for Asia
• Traditional Model
• Experiences to be gain
• Management in Singapore
• Flexible
• Scientist rather than admin role
• Locally Based
• Full Time
• Global and Local Experience
• Both Pharma & CRO experience
Highly
Experienced
High
Reten2on
Rates
Con2nued
Development
Added
Exper2se
CRITERIA
QUALITY
MOTIVATIONS
TRAINING

8. Key Therapeutic Experience
I
16%
II
8%
IIa
3%
IIa/IIb
3%
III
40%
III/IV
3%
IV
19%
Registry
8%
STUDY PHASES
• Oncology
• Infectious diseases
• Neurology & CNS
• Inflammation
• Respiratory/ pulmonary
• Renal
• Haematology
• Vaccines
• Endocrinology
• Urology
• Gastroenterology
• Nutrition
• dermatology
• Cosmetics
• Surgery
• Trauma
• Allergy/ immunology
• Autoimmune

9. ClinActis Pte Ltd - 112 Robinson Road - #06-04 - Singapore 068902
Telephone: +65 6436 5500 - info@clinactis.com
Contact Us for More Information
Imen Jelassi, PharmD, MSc
EU Director, Strategic Relations
M: +33 6 28 11 13 71
E: ijelassi@clinactis.com
Bill Van Nostrand, MBA
Head of Business Development,
North America
M: +1 908-229-5220
E: bvannostrand@clinactis.com