ClinActis FSP Model

ClinActis Pte Ltd - 112 Robinson Road - #06-04 - Singapore 068902 Telephone: +65 6436 5500 - [email protected]

Functional Service Provider Geography - People - Services

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.


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.


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.

Christophe Tournerie, MD – Owner 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.


About Our Founder

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.

ClinActis Pte, Ltd. – An Asia Pacific Based CROStrategic Partnership Offering§  Geographic Reach§  People§  ServicesStrategic Partnership Models§  Non-dedicated resources§  Dedicated resources§  Flexible Resources


Functional Service Provider – Operational Expertise and Footprint

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, Taiwan, 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

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).


Functional Service Provider – Geographic Reach

Our Geographic Reach Australia/New Zealand, Malaysia, Hong Kong, India, Indonesia, Philippines, Singapore, South Korea, Taiwan, Thailand, Japan and Vietnam

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.


Functional Service Provider – People

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.

Wee Lin Tan, Regional Project Manager Wee Lin graduated from the National University of Singapore with a Pharmacy degree and worked as a Pharmacist for 2 years. With her passion in improving health of the patients, she joined an international clinical research organization to train as a CRA. Thereafter, she continued her CRA career in an international pharmaceutical company before joining ClinActis Pte Ltd. Since joining ClinActis in year 2010, Wee Lin has progressed from a CRA to Project Lead and is now a Regional Project Manager. With approximately 10 years


Functional Service Provider – People (continued)

experience in the clinical research industry, Wee Lin has accumulated experience in numerous therapeutic areas such as cardiovascular, dermatology, infectious diseases, nutrition, oncology etc. In line with ClinActis’ vision to be the reference CRO in Asia Pacific, Wee Lin has successfully completed clinical trials within or earlier than timelines and study budget. Her clinical trial experience ranges from Phase I to IV studies and from protocol design to manuscript development. Some of Wee Lin’s achievements include first patient in for global trials, 100% safety reporting compliance, 100% achievement of deliverables etc. Besides proactively identifying risks, Wee Lin believes in actively engaging stakeholders (Sponsor, investigator, site personnel, CRAs, data managers, medical monitors etc) to ensure that project status is communicated clearly to all parties and instructions are implemented correctly.

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 – Services

Clinical Project Management Logistics Site Management Clinical Monitoring Clinical Research and ICH GCP Training

Functional Service Provider Temporary Clinical Staffing Data Management Medical Writing Consulting Services


Functional Service Provider – Resource Strategy

Project Management

Staffing

Contracts

Planning

Costs

Study

Voluminous

Shared

Tasks

Hour

Pipeline

Streamlined

Dedicated

Resources

Resource

Tac?cal Strategic

CRO Systems Shared


Functional Service Provider – Partnership Structure

Client Project Manager

Data Management

Site Management

ClinAc?s Project Manager

Execu?ve Oversight

Execu?ve Sponsor Execu?ve Sponsor

Partnership Head Partnership Head

Opera?onal Services

Opera?ons Management

Project Delivery Team

Medical Wri?ng

Clinical Monitoring

Clinical Opera?ons

Project Management

Client/Partner

Client/Partner


Functional Service Provider – Management Plan

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) Management Tools §  Alliance Manual/Guide (for all participants/users) §  Operations Plan §  Performance Dashboard §  Web Portal for all Communications and Reports


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


Functional Service Provider – Partnership Models (Continued)

Example of Resource Planning for Flexible Model

0

5

10

15

20

25

30

35

Months

# of

Sta

ff

Non-‐Dedicated

Dedicated Staff

Actual FTEs


Functional Service Provider – Relationship Benefits §  Reduces Overall Drug Development Costs §  Saves Staffing/Hiring/Human Resource Costs §  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


Contact Us for More Information

Imen Jelassi, PharmD, MSc EU Director, Strategic Relations M: +33 6 28 11 13 71 E: [email protected]

Bill Van Nostrand Head of Business Development, North America M: +1 908-229-5220 E: [email protected]

ClinActis FSP Model

Health & Medicine

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