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 Experience • 45 years experience in clinical research in pharmaceutical and biotechnology companies as well as CROs • 28 years experience in Asia Pacific, including Australia/New Zealand, China, Malaysia, Hong Kong, India, Indonesia, The Philippines, Singapore, South Korea, Taiwan, Thailand and Japan • Extensive knowledge of regulatory frameworks, best KOLs and sites across the region • Vast therapeutic experience including Cardiovascular, CNS, Endocrinology, Infectious diseases, Oncology, and Respiratory

1. ClinActis)Pte)Ltd)). 112)Robinson)Road). #06.04)). Singapore)068902)). Telephone:)+65)6436)5500)). info@clinactis.com
Current Scenario of Paediatric Clinical
Trials in the Asia Pacific Region

2. ClinActis)Pte)Ltd)). 112)Robinson)Road). #06.04)). Singapore)068902)). Telephone:)+65)6436)5500)). info@clinactis.com
Your%Proactive%Clinical%Research%Partner%in%Asia%Pacific
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.
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.

3. ClinActis)Pte)Ltd)). 112)Robinson)Road). #06.04)). Singapore)068902)). Telephone:)+65)6436)5500)). info@clinactis.com
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&
proEactive&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.

4. ClinActis)Pte)Ltd)). 112)Robinson)Road). #06.04)). Singapore)068902)). Telephone:)+65)6436)5500)). info@clinactis.com
About&Our&Founder&and&CEO
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&antiMHIV&products.
His&introduction&to&the&pharmaceutical&industry&was&as&Medical&Director&in&an&American&
biotechnology&company&developing&antiMHIV&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&multiMnational&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.

5. ClinActis)Pte)Ltd)). 112)Robinson)Road). #06.04)). Singapore)068902)). Telephone:)+65)6436)5500)). info@clinactis.com
Operational+Expertise+– Regional+Footprint
ClinActis)Experience
! 34+years+experience+in+clinical+research+in+
pharmaceutical+and+biotechnology+companies+as+
well+as+CROs
! 28+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

6. ClinActis)Pte)Ltd)). 112)Robinson)Road). #06.04)). Singapore)068902)). Telephone:)+65)6436)5500)). info@clinactis.com
! There is a high level of interest among sites in the Asia Pacific region in
conducting pediatric trials across various therapeutic indications.
! There also appears to be an adequate patient pool in many indications, and the
availability of a database of healthy subjects can assist in faster screening of
subjects for vaccine trials.
! No major insurmountable challenges were identified in conducting paediatric
trials.
Asia%Pacific%Conditions

7. ClinActis)Pte)Ltd)). 112)Robinson)Road). #06.04)). Singapore)068902)). Telephone:)+65)6436)5500)). info@clinactis.com
! Complexity of the consent and assent process across the countries needs to be
considered.
! Adapt to local or sites’ needs including trial design adaptations for this
population to ensure compliance (minimize invasive procedures, placebo
control, visit schedules versus school timings, etc).
! Eighty percent confirmed needing an assent from paediatric patients; 81%–95%
confirmed acceptance of placebo-controlled and pharmacokinetic studies by
ethics committees; and 37% cited challenges in conducting studies in this
population.
Asia%Pacific%Challenges

8. ClinActis)Pte)Ltd)). 112)Robinson)Road). #06.04)). Singapore)068902)). Telephone:)+65)6436)5500)). info@clinactis.com
Current'Paediatric'Age'Classifications'(ICH'Guidance'E11*)'Identify'5'Separate'
Categories:'
Age Group Category
Born at < 37 weeks gestation Pre-term, newborn infants
< 0 day Pre-term, newborn infants
0-27 days Term newborns
28 days – 23 months Infants and toddlers
2-11 years Children
12 to 16-18 years depending on region Adolescents
International Conference of Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use

9. ClinActis)Pte)Ltd)). 112)Robinson)Road). #06.04)). Singapore)068902)). Telephone:)+65)6436)5500)). info@clinactis.com
! As per new regulations, now the guidance required the paediatric data to be
collected all clinical trials for new therapies.
! It is important to understand and to be prepared to meet the complex demands
based on some of the factors below before conducting the pediatric trial in the
region:
! Understand the paediatric regulatory landscape in a country.
! Expertise in protocol design that meets the local need
! Identify the high performing and experienced investigator sites
! Implementation and support for the investigator sites and staff during study
initiation.
! Customize laboratory testing and strategy to optimize the clinical plan (minimize
blood volume while meeting protocol needs)
New$Therapy$Guidance

10. ClinActis)Pte)Ltd)). 112)Robinson)Road). #06.04)). Singapore)068902)). Telephone:)+65)6436)5500)). info@clinactis.com
Regulatory+Dossier+for+
Paediatric+Clinical+Trials

11. ClinActis)Pte)Ltd)). 112)Robinson)Road). #06.04)). Singapore)068902)). Telephone:)+65)6436)5500)). info@clinactis.com
Item SGP MYS TWN KOR THA HKG PHP IND AUS
Protocol √ √ √ √ √ √ √ √ √
IB √ √ √ √ √ √ √ √ √
CRF √ √ √ √ √ √ √ √ √
Informed consent √ √ √ √ √ √ √ √ √
Investigator’s CV √ √ √ √ √ √ √ √ √
Nonclinical report √ √ √
Clinical report √ √ √
CMC report √ √ √ √
GMP cert /COA for IMP √ √ √ √ √ √ √ √ √
IMP sample for IND √
(*SGP= Singapore; MYS= Malaysia; TWN= Taiwan, KOR= Korea; THA= Thailand; HKG= Hong Kong; PHP= Philippines; IND= Indonesia; AUS= Australia)

12. ClinActis)Pte)Ltd)). 112)Robinson)Road). #06.04)). Singapore)068902)). Telephone:)+65)6436)5500)). info@clinactis.com
! The child/minors (less than 18 years of legal age; depending on country) must give
consent to being enrolled in a clinical trial; unless the child/minors being determined by
the investigator that he/she is lack of capacity, insufficient understanding and
intelligence to give informed consent.
! The Principal Investigator must ensure that, at the earliest feasible opportunity:
! The child/minors is given a full and reasonable explanation of the required elements of the
informed consent; and
! The child/minors consent to continue being a subject in the trial is obtained if re-consent is
applicable.
! If the child/minors refuses to re-consent, the Principal Investigator must ensure that the
child/minors eases to be a subject in the clinical trial.
Informed Consent Requirement for Pediatric Clinical Trials

13. ClinActis)Pte)Ltd)). 112)Robinson)Road). #06.04)). Singapore)068902)). Telephone:)+65)6436)5500)). info@clinactis.com
! As per the IRB requirement, an assent informed consent form with layman term for the
child/minors to be used.
! The contents of the assent informed consent form must contains the below:
! Objective of the trials
! The trial is conducted in subjects having a disease or condition for which the product being
tested in the trial is intended;
! There is some direct benefit for the group of subjects involved in the trial;
! The foreseeable risks to the subjects involved in the trial are low; and
! The negative impact on the well-being of subjects involved in the trial is minimised and low.
Informed Consent Requirement for Pediatric Clinical Trials (Continued)

14. ClinActis)Pte)Ltd)). 112)Robinson)Road). #06.04)). Singapore)068902)). Telephone:)+65)6436)5500)). info@clinactis.com
! The Parent or Deputy or Legal representative/guardian of the child/minor must give
consent for the child/minors being a subject in a clinical trial.
! A copy of the following documentation should be maintained on file, where applicable,
for enrolment of child into a clinical trial:
! Deputy of child*: Certified Court Order Letter; or
! Parent of child: Birth certificate of the minor; or
! Legal Guardian of child: Certified Court Order Letter
Informed Consent Requirement for Pediatric Clinical Trials (Continued)

15. ClinActis)Pte)Ltd)). 112)Robinson)Road). #06.04)). Singapore)068902)). Telephone:)+65)6436)5500)). info@clinactis.com
Sites&for&Paediatric&Clinical&Trials&In&Asia&

16. ClinActis)Pte)Ltd)). 112)Robinson)Road). #06.04)). Singapore)068902)). Telephone:)+65)6436)5500)). info@clinactis.com
Country
Number,of,potential,Sites,to,conduct,
Paediatric,Clinical,Trials
Sites,with,NICU ICH,sites
Korea 8?10,sites 8 Yes
Thailand 6?8,sites 5 Yes
Vietnam 6?8,sites 6 Yes
Taiwan 8?10,sites 8 Yes
Philippines 8,sites 7 Yes
Malaysia 8?10,sites 6 Yes
Singapore 3,sites 3 Yes
Indonesia 6?8,sites 4 Yes
Hong,Kong 3,sites 3 Yes
Site Capabilities

17. ClinActis)Pte)Ltd)). 112)Robinson)Road). #06.04)). Singapore)068902)). Telephone:)+65)6436)5500)). info@clinactis.com
ClinActis’*Capabilities*and*Experience*
in*Paediatric*Clinical*Trials*

18. ClinActis)Pte)Ltd)). 112)Robinson)Road). #06.04)). Singapore)068902)). Telephone:)+65)6436)5500)). info@clinactis.com
ClinActis Organizational Structure
Data Management
Biostatistics
Medical Writing
CRAs CRAs
CEO
Head, Clinical
Research
Services
(CEO Acting)
Singapore Taiwan Korea Hong Kong Philippines Malaysia Thailand Indonesia Vietnam
QA
Director, Strategic
Relations
(EU)
Administrative
Affairs
General, Finance,
Recruitment, IT
(SG)
Legal Counsel
Current
External support
CRAs
CTAs
Country Leader
CRAs
Country Leader
CRAs
CRAs Country Leader
CRAs
Planned
China
Country Leader
CRAs
India
Australia
Head of Business
Development
(USA)
Country Leader
CRAs
Country Leader
CRAs
Medical Affairs
(CEO Acting)
Regional PMs
(SG & HK)
Director,)Clinical)
Research
(SG)
Ass.)Director,)Clinical)
Operations
(SG)

19. ClinActis)Pte)Ltd)). 112)Robinson)Road). #06.04)). Singapore)068902)). Telephone:)+65)6436)5500)). info@clinactis.com
ClinActis 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 gained
• Management in Singapore
• Flexible
• Scientist rather than admin role
• Locally(Based
• Full(Time
• Global(and(Local(Experience
• Both(Pharma(&(CRO(
experience
Highly
Experienced
High)Retention)
Rates
Continued)
Development
Added
Expertise
CRITERIA
QUALITY
MOTIVATIONS
TRAINING

20. ClinActis)Pte)Ltd)). 112)Robinson)Road). #06.04)). Singapore)068902)). Telephone:)+65)6436)5500)). info@clinactis.com
! Paediatric Nutrition
! Juvenile Idiopathic Arthritis
! Skin Disorder
! Hepatitis Vaccine
! Flu Vaccine
! Infant Colic
ClinActis Staff Therapeutic Areas
Experience in Paediatric Clinical Trials
! Site selection and feasibility
! Contracts
! Organize the Investigator Meeting
! Submissions to IRBs
! Submissions to RAs
! Initiation visits
! Project Management
! Monitoring
! Ensure data authenticity by checking
source data
! Ensure data completeness
! Problem solving
! Close out visits
ClinActis Staff Role And Experience
in Pediatric Clinical Trials

21. ClinActis)Pte)Ltd)). 112)Robinson)Road). #06.04)). Singapore)068902)). Telephone:)+65)6436)5500)). info@clinactis.com
Our Capabilities in
Paediatric Clinical Trials
Age Group
ClinActis Studies
Paediatrics
0-3 yrs 7
3-6 yrs 3
6-10 yrs 3
10-12 yrs 3
12-18 yrs 3
Total
Studies
(not including
the same
study)
10
Country
Avg. Years
of Clinical
Trial
Experience
Avg. Years of
Paediatric
Experience
Number of
CRAs with
PED CT
Experience
Paediatric Clinical
Trial Therapeutic
Experience
Phase of the
Clinical Trial
Sites Managed
Singapore 9 2 1
Paediatric Nutrition
Skin Disorder
Infant Colic
II, IV 3
Philippines 9 2 1
Juvenile Idiopathic
Arthritis II 2
Indonesia 8 3 1
Skin Disorder
Pediatric Nutrition II, IV 8
Taiwan 5 2 1
Infant colic
II 3
Australia 9 2 1
Infant Colic
Pediatric Nutrition
II, IV 1
Vietnam 7 5 1
Hepatitis Vaccine
Flu Vaccine
Pediatric Nutrition
III, IV
4

22. 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
Head of Business Development,
North America
M: +1 908-229-5220
E: bvannostrand@clinactis.com