A2PRA_PRA Fact Sheet_Dec2014

C L I N I C A L D E V E L O P M E N T S O L U T I O N S F O R J A PA N
CLINICAL
DEVELOPMENT
SOLUTIONS
F O R J A PA N
A2PRA is a joint venture between A2 Healthcare (one of Japan's largest CROs) and
PRA Health Sciences (a top 5 global CRO) that delivers both clinical development
and Embedded (dispatch worker) solutions across all phases of drug development
in Japan. Working with biopharmaceutical companies, A2PRA brings innovative
approaches, modern technologies, scientific expertise, and the global reach necessary
to meet the demands of a diverse marketplace.
A 2 H E A LT H C A R E
EXPERTISE
A2 HEALTHCARE
CORPORATION
N o . OF CLINICAL M O NITOR I NG
S E RVIC ES*
Gl
ob
a
in
ord
proven track rec
ith
s
eC
w
RO
Enabling
Innovation
for Value
Creation
Excellence in
Global Clinical
Operations
Process,
Delivery
and
Execution
PEOPLE,
nd Embeded
Japanese
Expertise,
Reputation
and
Capabilites
GLOBAL
ice a
PEOPLE
PROCESS
TECHNOLOGY
PROCESS
AND
TECHNOLOGY
POWERHOUSE
lD
el
op
me
nt S
olutions
Market Leadi
n
gJ
ap
an
e
*OVER THE PAST 5 YEARS
Gl
ca
N o . OF CLINICAL STUDIES *
in
Cli
ni
10,000+
3,500+
Market Leader
erv
N o . O F EMP L O Y E E S
ice Programs
lS
P R A H E A LT H S C I E N C E S
Serv
ul
* O VE R TH E PA S T 3 YEA R S
o
l
ba
ll
Fu
PRA HEALTH
SCIENCES
lF
860+
170+
A2PRA provides sponsors highly-trained project teams, streamlined processes, and cutting-edge
technology to support their comprehensive drug development needs. In conjunction with a strong
base of Japanese local knowledge, A2PRA executes all projects using PRA SOPs, processes and
systems to ensure consistency for global project teams, and programs.
ev
N o . O F EMP L O Y E E S
LOCAL KNOWLEDGE - GLOBAL EXPERIENCE
With a sole focus on clinical development in Japan, A2PRA delivers customized solutions for
sponsors conducting studies and/or placing sites in Japan. The exclusive PRA – A2 Healthcare
collaboration leverages PRA's excellence in global clinical operations processes, delivery, and
execution with A2 Healthcare’s local expertise, reputation and capabilities. A2 Healthcare offers
unique insights and access to the Japanese market and PRA has a proven record in global,
full-service, and Embedded programs. A2PRA’s capabilities in Japan include:
New Drug Development
Strategic Solutions
Post-Marketing Research
Medical Affairs
Regulatory Affairs
Project Management
Clinical Operations
Patient Recruitment
Clinical Monitoring
Data Management
Biostatistics
Functional Services
Pharmacovigilance
Medical Writing
QA Audits
日本の多くの人々がドラッグラグのない時代を待ち望んでおり、その実現のため、
日本の薬事規制や臨床開発環境においては急速なイノベーションが進んでいます。
A2PRAが提供するのは、日本と世界を結ぶ最新かつ最適なソリューションです。
市川 宏司、代表取締役COO
HIROSHI ICHIKAWA, President and COO
“It’s not enough to be global. A2PRA Project
teams harness knowledge of Japanese regulations
and customs to make quality decisions that are
aligned with study goals.”2
SEAN LEECH, CEO and Representative Director
A2PRA
1
“People in Japan are truly craving the era of no drug lag. Innovation of the Japanese regulations and the clinical development environment is taking place very rapidly to achieve this goal.
A2PRA provides the most effective and updated solutions to bond Japan and the world.” – HIROSHI ICHIKAWA, President and COO
私たちは“グローバル” であることだけに満足しません。A2PRAのプロジェクトチームは、“グローバル“の豊富な実績・経験と日本の薬事規制や医療習慣に関する知識を融合、高度な戦略決定を可能し、試験を成功へと
導きます。ショーン リーチ、代表取締役CEO
2
The advantage of having a local presence goes
deeper than simply already being wherever
you may want to go. It’s the level of integration,
of familiarity with local people and available
resources, combined with the expertise to know
what’s needed and how to get it, that gives our
clinical development partners an edge. We
never forget that every global study is executed
locally. Our team harnesses practical knowledge
of Japanese regulations, standards of care and
cultural customs to maximize the safety and
efficiency of every study.
We empower our project teams to implement
innovative strategies that are specifically
designed to connect study insights from around
the world and move our clients ahead. Because
with each and every study, we’re working with
our clients to change lives and make the world
a better place.
A2PRA provides clinical development and Embedded (dispatch worker) solutions across all phases of biopharmaceutical drug
development in Japan. To learn more, please visit us at a2pra.com or email us at [email protected].