ClinActis Delivers Quality Clinical Trials in Asia Pacific

ClinActis Pte Ltd - 112 Robinson Road - #06-04 - Singapore 068902
Telephone: +65 6436 5500 - info@clinactis.com
Logistics of Asian
Based Clinical Trials

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

Importation of Drugs and Governing Bodies
Logistics
One concern for sponsors is the
importation and distribution of drugs and
biologics into foreign countries. Dealing
with customs and governing bodies can
be challenging. ClinActis supports the
shipment of drugs and biological
samples through carefully planned and
well managed procedures, especially for
temperature and time-sensitive
products.
With local knowledge, use of specialist
logistics providers (local agents to
facilitate customs clearance), set up of
regional distribution hub and careful
selection of regional central laboratory,
the risks involved in the movement of
clinical trials materials will be mitigated.

Drugs
Centralized Drug Depot
In general, the solution ClinActis would
recommend is to set up a centralized drug
depot in Asia with/without country specific drug
depot. To better navigate global trade
regulations, differences in customs
requirements, and regulations, ClinActis works
closely with international drug depots that have
set up offices in Asia specifically for
management of clinical trial logistics, eg:
Zuellig, Fisher Clinical Services etc.
Singapore
For centralized depot, Singapore is a good option not only due to its centralized
geographical location but also the stringent and carefully monitored drug depots, with cGMP
facilities. Such arrangement allows flexibility in drug movement to support active recruitment
sites. Usage of tools such as IVRS and IWRS allow real-time monitoring of the recruitment
and inventory levels at each site for better management of the drug supply vs demand,
including expiry dates management.

Drugs (Continued)
Drug Management
Nevertheless, country specific drug depots could also be a
pragmatic solution to avoid potential delays with regulatory
approvals. ClinActis will propose the best solution for drug
management based on Sponsor’s requirement, our experience with
the shippers and our local knowledge. ClinActis offers country
specific solutions for country specific requirements. For example, in
the Philippines, the Import License is site specific, valid for single
import only and expires in 6 months. Not only does ClinActis track the validity of the Import
License, but also once the current Import License is used and we apply for a new License to
ensure that a valid License is always available. In many countries, there are also strict
requirements for importers i.e. the qualifications of importers and the type of company
performing the import (Sponsor, Distributor or CRO). Customs regulations in these countries
are also complex and are strictly adhered to by customs staff. Any issues with the shipment
itself, or the accompanying paperwork, can result in materials being held in customs for
prolonged periods. Working with ClinActis, who have up to date working knowledge of these
intricacies, as well as careful forward planning will easily help Sponsors ensure the smooth
running of a clinical trial.

Biological Samples
Temperature Sensitive
Biological samples are both time and
temperature sensitive; temperature
requirements can range from ambient to
– 80 degrees Celsius and may
sometimes need to be shipped to the
central laboratory within 72 hours to
maintain specimen integrity. Global
shippers such as TNT, DHL, World
Courier can assist with the packaging,
providing packaging materials (eg: dry
ice) and door to door shipment.
Regional central laboratories have also been set up in Asia Pacific: Lab Connect, Lab
Corps, Quest Diagnostics etc. The use of regional central laboratory can reduce shipment
time, shipment cost and even specimen processing time while adhering to global standards
for the specimen analysis.

Biological Samples (Continued)
Real-Time Shipment Tracking
To ensure that the specimens are seamlessly received by the
laboratory, ClinActis can also assist sites with dummy
specimen shipments to verify the transit time, ensure that the
sites are well trained to pack and label the specimens,
arrange the courier and complete the paperwork required. Not
only that, ClinActis will monitor the real-time shipment of
specimens to the central laboratory with the use of global
shippers’ tracking system. We could also arrange for International Air Transport Association
(IATA) training for site personnel on-site.
As Export License requirements differ from country to country throughout the region,
ClinActis will share our local expertise and advise Sponsors on the most suitable countries
and sites for trials with specific analysis requirements.

Clinical Sites
Singapore Healthcare Infrastructure
The infrastructure varies greatly
between countries and even within each
country itself. Singapore boasts one of
the world’s best healthcare
infrastructures, while in some second
tier countries, certain provinces can be
more advanced than others and when
more sophisticated equipment is
needed, they need to borrow from the
better equipped hospitals. Nowadays in
these countries overall advances in
technology and equipment are visible, even if the building appears less developed.
The choice of site depends on the clinical study’s complexity, the logistics, standard of care
and type of treatment, among other criteria. For a Phase I study where multiple PK sampling
is required, or a complex oncology trial that needs sophisticated diagnostics equipment, a
first tier country should generally be considered.

Clinical Sites (Continued)
GCP Certified Sites
Second tier countries present advantages for where a large
patient pool and less advanced equipment is needed, for
certain therapeutic areas such as infectious and tropical
diseases, or when the protocol requires treatment naïve
patients.
Although South East Asian countries are at different stages of
development, significant advances are being made and the
large increase in GCP certified sites have been established to
support clinical research activities. Singapore, Malaysia and
Korea’s governments, for example, have been taking an
active role in investing and building local clinical research
networks.

Investigators
Motivated and Enthusiastic
Asia has a large pool of well-educated,
highly motivated and enthusiastic
investigators, who have conducted their
studies at well-reputed institutions in the
US or Europe. In the majority of the
countries it is the institution which is paid
with a per patient fee, although in the
Philippines this is a part institution/ part
PI payment. Still, the main motivation is
to work as part of international clinical
trials, increasing their expertise and
hopefully having their name in a
publication, as this will largely help moving forward with their academic career. Investigators
are more conservative than in Western countries, so generally when they provide feasibility
results there will be no great surprise when it comes to the recruitment rates of a study.

Patient Recruitment and Retention
Asia’s High Ranking
According to a 2012 Tufts CSDD report,
clinical site activation rates in Asia Pacific
are at one of the highest, with 91% of sites
successfully progressing through the study
start up stages and recruiting the first
patients in at speed. Not only are site
activation rates high but Investigative sites
operating in this region achieved target
enrollment levels at 107%, making it the top
region in that respect. Despite these figures,
with clinical research activities in the region
Growing and the increase of more complex protocols, it is necessary to emphasize the
importance of focusing on Patient Recruitment. At site level this is being recognized, in
Singapore for example, some sites now have in-house ‘recruitment teams’ to support these
activities.

Recruitment and Retention (Continued)
Patient / Doctor Trust
Across all Asian cultures, physicians are highly regarded and
patients put their complete trust in their doctors creating an
advantage for recruitment and maintaining low drop-out rates.
In Asia more of an emphasis must be placed on the informed
consent process, ensuring site staff are sufficiently trained in
this area and are educating trial subjects early on.
On top of this, extra efforts need to be made ensuring participants feel involved for the trial
duration. The 2013 CISCRP Perceptions and Insights study, on study participant
experiences, showed that in Asia Pacific, the prospect of receiving clinical results and
regular updates about research during the study were the top factors for influencing their
decision to participate. A further study conducted showed that a significantly higher
percentage of study participants in Asia Pacific were receiving updates on either a daily
basis or at least a few times a week, compared to the US and Europe.

Recruitment and Retention (Continued)
Regional Success Factors
Retention strategies are key to success in the region:
§  Assigning a dedicated study coordinator to each trial
subject in order to create familiarity
§  Including personal touches, such as birthday cards in
pediatric studies
§  Building in efficiencies, for example, combining study visit
with other regular visits the patient needs to make
§  Patient meetings, to create a sense of community and
allow to reinforce important messages
§  Weekly phone calls
The same report showed a significantly higher proportion of Asia Pacific study
participants rating free procedures, free study drug and their relationship with study
staff as major motivators to stay in the study: 121%, 140% and 100% respectively
more than their European counterparts.

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 Delivers Quality Clinical Trials in Asia Pacific

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