ClinActis FSP Model

ClinActis Pte Ltd - 112 Robinson Road - #06-04 - Singapore 068902 Telephone: +65 6436 5500 - info@clinactis.com
Functional Service Provider
Geography - People - Services

Your Proactive Clinical Research Partner in Asia Pacific
ClinActis Pte Ltd is a full service CRO providing clinical
trial services to the pharmaceutical, medical device,
medical nutrition and biotech companies in Asia Pacific.
Established in 2009, ClinActis Pte Ltd is headquartered
in Singapore.
ClinActis Value Proposition
ClinActis is a multicultural company. As such, the team
is able to communicate effectively with international
clients.
ClinActis is exclusively focused on Asia Pacific, with solid
expertise in applying international quality standards to
regional specificities. ClinActis is flexible in our approach
to work scope and budgeting and contracting process.
Delivering Quality to Our Clients
ClinActis is committed to implementing international standards in clinical trials. Our 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.

Mission and Vision
With headquarters based in Asia, all corporate decisions
are made within the region, in order to better anticipate
our client needs and adapt to local specificities.
Vision
Our vision is to become the reference CRO specialized in
conducting clinical research in Asia Pacific, offering state
of the art quality services, with cost effective solutions.
We strive to employ people with genuine expertise in the
region and with a passion for excellence, to work with
our clients in the most pro-active way, and to build a
relationship based on trust, transparency and strong
ethics.
Mission
Our mission is to provide our clients with unique and
dynamic expertise in applying global drug development
standards to the specificities of each country in the Asia
Pacific region.

About Our Founder
Christophe Tournerie, MD – Founder and 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.

Why Asia – Why Now – Why ClinActis
Discussion With Christophe Tournerie, MD – Founder and CEO
During the early 2000’s, Asia generated a lot of hope for drug companies in terms of clinical research capabilities.
Although the market here is still in its infancy, it offers great potential which is not yet fully utilized. This potential
market requires CROs to possess clinical expertise across multiple therapeutic areas with the flexibility to work across
sponsor development pipelines. Our expertise is in multiple therapeutic areas and our flexibility makes us unique in our
ability to respond to any kind of sponsor request in terms of clinical research and drug development in the APAC
Region.
ClinActis management attracted and developed ICH/GCP certified talent across APAC for multiple types of studies and
therapeutics to meet the demand of conducting both global and local country studies with a flexible and agile business
model that meets industry demands.
Our FSP model allows our clients to choose their trials by therapeutic expertise for one study or multiple studies in a single country or throughout
APAC through accelerated study start up with our people, our extensive investigator network and Contract Library facilitating fast enrollment.
Our model allows a sponsor to utilize our experts as ‘Resources’ and not just for a ‘Task’ driven service. This flexibility of service is available across
multiple therapeutic studies from day-to-day or week-to-week??. Our flexible FSP Model eliminates ‘down-time’ for sponsors when engaged with
ClinActis because our experts can always be utilized to reduce cost and save development time.
All these reasons are why ClinActis’ FSP Model makes us the “Leading APAC Regional CRO”.

Functional Service Provider – Operational Expertise and Footprint
ClinActis Pte, Ltd. – An Asia Pacific Based CRO
Strategic Partnership Offering
 Our Geographic Reach
 Our People
 Our Services
Strategic Partnership Models
 Non-dedicated resources
 Dedicated resources
 Flexible Resources
ClinActis Experience
 33 years experience in clinical research in pharmaceutical and
biotechnology companies as well as CROs
 27 years experience in Asia Pacific, including Australia/New Zealand,
China, Malaysia, Hong Kong, India, Indonesia, the Philippines, Singapore,
South Korea, Ta iwan, Thailand, Japan and Vietnam
 Extensive knowledge of regulatory frameworks, best KOLs and sites across
the region
 Vast therapeutic experience including Oncology, Infectious diseases,
CNS, Cardiovascular, Endocrinology, and Respiratory

Functional Service Provider – Geographic Reach
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).
Our Geographic Reach Australia/New Zealand, China, Malaysia, Hong
Kong, India, Indonesia, Philippines, Singapore, South Korea, Taiwan,
Thailand, Japan and Vietnam

Functional Service Provider – Our People
Paul Lim, Director Clinical Research
Paul Lim has 15 years’ clinical research experience with global pharmaceutical
companies and global CROs. He holds a Master’s Degree in Pharmacy (Clinical
Pharmacy) and started his clinical research career as a Clinical Pharmacist in the
National University Hospital in Malaysia. He later joined an international CRO as
senior CRA in Singapore, and another CRO as Clinical Operations Manager.
Subsequently, he joined a Biotech company as Regional Clinical Research &
Development Manager Asia, Australia, Europe, US, Europe, and Middle-East regions.
After this experience, he joined an international pharmaceutical company as Senior
Clinical Development Manager Clinical Development, Greater China and Asia. Lastly,
before joining ClinActis, he held the position of Senior Clinical Site Manager Asia in
another leading international pharmaceutical company.
His therapeutic areas experience includes cardiovascular, oncology, endocrinology,
infectious diseases, neurology, and respiratory diseases. Paul brings with him a
wide breadth of project management and clinical research experience.

Product Development Services in Asia Pacific
ClinActis Pte Ltd is a full service CRO providing
clinical trial services to the pharmaceutical,
medical device, medical nutrition and biotech
companies in Asia Pacific. Established in 2009,
ClinActis Pte Ltd is headquartered in Singapore.
Services Include:
Functional Service Provider
Clinical Project Management
Regulatory
Logistics
Site Management
Clinical Monitoring
Clinical Research and ICH GCP Training
Temporary Clinical Staffing
Data Management
Medical Writing
Consulting Services
Functional Service Provider – Our Services

Planning
Strategic
Study
Tactical
Pipeline
Voluminous Contracts Streamlined
Shared Staﬃng Dedicated
Tasks Project Management Resources
Hourly Cost / Time Savings Resource
CRO Systems Shared
Functional Service Provider – Resource Strategy

ClientProject
Manager
Data
Management
Site
Management
ClinActis
Project
Manager
Executive Oversight
Executive Sponsor
PartnershipHead
Operational Services
Operations Management
Project Delivery Team
Medical Wri?ng
Clinical
Monitoring
Clinical
Opera?ons
Project
Management
Client/Partner
Partnership Head
Client/Partner
Execu?ve Sponsor
Functional Service Provider – Partnership Structure

To effectively develop and manage the partnership, a management
structure must be defined to include:
Management Teams
 Strategic Management Team (those responsible for day-to-day
activities for a particular study/group of studies)
 Operations Management Team (those responsible for the segment
outsourced [function, therapy, phase])
 Senior Management Team (those responsible for outsourcing and
business strategy)
 Local Deployment of CRAs
 Country Specific PMs
Management Tools
 Alliance Manual/Guide (for all participants/users)
 Operations Plan
 Performance Dashboard
 Web Portal for all Communications and Reports
Functional Service Provider – Management Plan

Functional Service Provider – Partnership Models
Non-Dedicated Resources
 Transactional Relationship (project by project)
 Request for Proposal (RFP) drives process
 Services Start with Signed Agreement
 ClinActis Delivers Specifications Per Project
 Resources are assigned on a project-by-project basis
 Works Well for Limited Outsourcing and Short-Term Planning
Dedicated Resources
 Dedicated Resources Work Exclusively with Client
 ClinActis is Responsible for Managing the Dedicated Staff
 Customer Provides Regular Resourcing Forecasts to Allocate Staff
 Consistency of a Dedicated Team Allows for Efficiencies, Flexibility and
Cost Savings
 This Model is Most Successful Given a Sufficient Volume of Work to
Outsource and Advanced Planning
Flexible Resources
 A Combination of Non-Dedicated and Dedicated to Maximize Flexibility
and Contain Costs

Example of Resource Planning for Flexible Model
25
20
15
10
5
0
30
35
Months
#ofStaff
Non-‐Dedicated
Dedicated Staﬀ
Actual FTEs
Functional Service Provider – Partnership Models (Continued)

Functional Service Provider – Relationship Benefits
 Reduces Overall Drug Development Costs
 Saves Staffing/Hiring/Human Resource Costs
 Takes Advantage of Local Domain Knowledge
 Reduces Recruitment Time and Effort
 Saves Time by Reducing “Procurement” Work Load
 Improves Quality by Developing Consistent Work Flow
Processes/Team
 Avoids Downstream Reintegration of Data
 Accuracy in Managing Study Budgets
 Accommodates Natural Attrition
 Consistent Provider of Services
 Management Oversight from ClinActis
 ClinActis Manages Capacity and Infrastructure Needs Depending
on Workload
 Opportunity for Role Reengineering

Colorectal K Case Study – Key Results (APAC CRO)
 Key Results and Lessons Learned
 Majority of submissions to IRB/ CA completed ahead of schedule.
 First global enrollment was from Asia.
 The first patient was screened in Malaysia on 05 JAN 2014 and the first randomization occurred on 15 JAN
2014.
 Good team work, local knowledge, communication and coordination within the stakeholders are important
in patient recruitment.

 Asia Pacific leg of a Global Randomized, Double-Blind, Placebo-Controlled Phase
III study in severe uncontrolled asthma, with a global enrolment duration of 2
years.
 10 countries involved, about 75 sites in Eastern Europe, Middle East, North
Africa, Latin America, and Asia.
 Malaysia achieved first recruitment 8 weeks after the sites were activated, with
the Philippines in just 6 weeks.
 After 1-year recruitment, the global enrolment reached 63% of the planned
randomization target, with the Philippines and Malaysia as the second and the
third key recruitment drivers worldwide.
Asthma Case Study – Key Results (APAC CRO)
Key Results and Lessons Learned
 First global enrolment was from Asia
 The first patient globally was screened and randomized in Malaysia
 It is key to ensure that the study protocol (eligibility criteria) takes into account international standards of
treatment
 It is important to have some direct communication between the sponsor and the sites. The investigator
meeting is very useful on this aspect

 Most experienced Team in Asia
 CEO with 18+ years of conducting ICH/GCP quality studies in
APAC
 Management 45+ Years
 CRAs Average 7+ Years
 Clinical Operations 13+ Years
 Deep Domain Knowledge of Sites, Patient Databases, Contracts,
CRCs and Principal Investigators
 Trusted Relationships with Health Authorities
 82+ ICH/GCP Compliant Oncology Sites
 Over 90+ CNS ICH/GCP compliant sites with Neurologists and
Psychiatrists
 Many of our sites have U.S. trained PIs
 Accelerated Study Start up due to our library of site relationships,
contracts and processes as well as country logistics
 Phase 1 trials in virtual every APAC country as part of global
submissions at substantially less cost and time
 A proven research model to accelerate new drug applications in
China
Why ClinActis? …Our Geography, People, and Services Deliver Results!

Contact Us for More Information
Bill Van Nostrand
Head of Business Development,
North America
M: +1 908-229-5220
E: bvannostrand@clinactis.com
Imen Jelassi, PharmD, MSc
EU Director, Strategic Relations
M: +33 6 28 11 13 71
E: ijelassi@clinactis.com

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