ClinActis - Case Study: Global Colorectal Oncology

ClinActis Pte Ltd - 112 Robinson Road - #06-04 - Singapore 068902
Telephone: +65 6436 5500 - info@clinactis.com
Case Study:
Global Colorectal Oncology

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.

Operational Expertise – Regional 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

Oncology Experience

Case Study – Global Colorectal Cancer
§  Study: Global Randomized, Double-blind, controlled Phase III
§  Global enrollment duration: 2 years
§  Study involving: 34 countries, 165 sites in Americas, EU and Asia Pacific
§  Study recruitment target : 550 patients
§  Responsibilities: ClinActis is responsible for Asia Pacific

Proactive Approach
When working as part of global trials, ClinActis recruits a month or two ahead of the US and
Europe. With work commencing simultaneously in all countries, this table represents the
countries that submitted for approvals for the study. Other countries involved were still
awaiting approvals.
Country HA first EC FPI
Malaysia 17-Mar-14 30-Oct-13 15-Aug-14
Taiwan 17-Dec-13 24-Dec-13 25-Aug-14
Hong Kong 08-Apr-14 03-Dec-13 24-Sep-14
Philippines 20-Jan-14 15-Feb-14 29-Oct-14
France 20-Nov-13 11-Dec-13 13-Nov-14
Hungary 18-Sep-14 7-Aug-14 No recruitment
Slovakia 2-Sep-14 8-Jul-14 No recruitment
Spain 10-Oct-14 10-Jun-14 28-Nov-15
Czech Republic 20-Aug-14 16-Jun-14 09-Nov-15
United Kingdom 15-Sep-14 1-Sept-14 19-Dec-15
USA Pending

Proactive Approach (Continued)

§  Malaysia, Taiwan and Hong Kong
achieved first recruitment 8 weeks
after the sites were activated, with the
Philippines in just 6 weeks
§  In comparison, in the other countries
in Europe it took 1 year to recruit their
first patient
§  US approvals were still ongoing
§  Submissions can be faster in Europe,
due to the translational aspect which
is obviously required in Asia
§  To overcome this and ensuring proper planning, by submitting the English documents
first to the IRB whilst having translations conducted in parallel. When the translations
are ready, these can be submitted to the IRB during the IRB Q and A

Recruitment Strategies

§  Precise definition of patient population/
specific tumor characteristics during
initial phase is the key to ensuring
enrolment success
§  Bi-weekly phone call to support the site
recruitment
§  Support sites in pre-screening activities
include discussion the actual patient
case with Sponsor to confirm patient’s
eligibility
§  Provide the inclusion and exclusion checklist to ease the screening process
§  Prepare physician referral and patient education materials
§  Increasing awareness of the study through face to face meeting with targeted physician
§  Newsletter and monthly recruitment status to maintain investigator’s interest in continued
participation

Recruitment Strategies (Continued)

§  Medical monitors work closely with site
to explain and communicate precise
definition of patient population,
especially rationale of difference in
frequency of CT scans (standard of
care vs. investigational requirements)
should be carefully explained
§  In some countries, the sponsor is
required to pay for comparator or co-
administered drugs to support the
clinical trial activity
§  Creating a dialog with the investigator for opinions of the compound that could help
sponsor to anticipate issues or questions from the site
§  Training investigators on the Informed consent process

Case Study – Key Results and Lessons Learned
§  Most submission to IRB/ CA completed ahead of schedule
§  First global enrolment was from Asia
§  The first patient was screened in Malaysia on 5 AUG 2014 and the first
randomization occurred on 15 AUG 2014.
§  Good team work, communication and coordination within the stakeholders
are important in patient recruitment.

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
Head of Business Development,
North America
M: +1 908-229-5220
E: bvannostrand@clinactis.com

ClinActis - Case Study: Global Colorectal Oncology

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