Evidera and CSS Collaborate to Develop Joint Real-world andPatient-centered Research Capabilities in JapanWILMINGTON, N.C. (August 21, 2019) – Evidera, a business unit of Pharmaceutical ProductDevelopment, LLC (PPD), has entered into an exclusive collaboration agreement with ClinicalStudy Support, Inc. (CSS), a subsidiary of Shin Nippon Biomedical Laboratories Ltd. (SNBL),
extending both organizations’ capabilities to deliver more robust consulting and analyticalcapabilities and creating a more complete geographic customer solution for clinical, real-worldand patient-centered research.
Evidera is a leading provider of evidence-based solutions to demonstrate the real-world
effectiveness, safety and value of health care products, and CSS is a clinical researchorganization based in Nagoya, Japan, that provides post-market real-world research services,
including database studies, questionnaire development and pharmacoeconomics.
Together, Evidera and CSS will leverage their combined expertise, including Japan-based
multilingual experts, to provide research services to global or Japan-based clients undertaking
studies that include a Japanese component. Such research services include the design andimplementation of real-world studies, epidemiological studies, qualitative and quantitative
patient-centered research, clinical outcome assessment development and validation, patient
recruitment for prospective studies, health economics modeling, and market access and healthtechnology assessment consulting services. The companies also are committed to the joint
development of direct-to-electronic medical record (EMR) and EMR-enabled observational
studies in Japan.
“Our collaboration with Evidera allows us to support larger global projects that may benefit fromour knowledge and expertise in Japanese-specific settings,” said Tatsuya Isomura, M.S., Ph.D.,
founder and chief executive officer of CSS. “Our clients will gain access to global project
management and operational resources that will enable larger and more complex research
programs, as well as more robust evidence of product value and safety.”
Karen Kaucic, M.D., president of Evidera, said, “This collaboration will allow us to provide
broader solutions for our clients as they develop evidence to support regulatory submissions
and market access in Japan. We are excited to work with our CSS colleagues to tap into realworld insights from the growing Japanese market, which is already the third-largest drug market
in the world, to inform and improve drug development and drug coverage decision-making at a
global level.”
Evidera and CSS plan to establish a joint office in Japan to facilitate collaboration and efficient
project delivery. The two organizations also intend to continue to explore opportunities toexpand their joint capabilities in data analytics and management, epidemiology, biostatistics,
medical writing and qualitative research.
Representatives of Evidera and CSS will attend the International Society for
Pharmacoepidemiology (ISPE) conference in Philadelphia Aug. 24-28 and will be available atbooth #202 to provide additional information on the collaboration and their expanded capabilities
in real-world and patient-centered research.

About Evidera
Evidera, a PPD business unit, is a leading provider of evidence-based solutions to demonstrate
the real-world effectiveness, safety and value of health care products. We help
biopharmaceutical, biotechnology and medical device companies generate the evidence
needed to optimize the market access and commercial potential of their products. For more
information, visit www.evidera.com.
About PPD
PPD is a leading global contract research organization providing comprehensive, integrated
drug development, laboratory and lifecycle management services. Our clients and partners
include pharmaceutical, biotechnology, medical device, academic and governmentorganizations. With offices in 48 countries and more than 21,000 professionals worldwide, PPD
applies innovative technologies, therapeutic expertise and a firm commitment to quality to help
clients and partners bend the cost and time curve of drug development and optimize value indelivering life-changing therapies to improve health. For more information, visit www.ppdi.com
About CSS
Since 2004, Clinical Study Support (CSS), Inc. has supported clinical research in real-world
settings and patient-reported outcomes questionnaire development. We have strong expertisein supporting professional experts from local to global levels through English communication.
For more information, visit www.jp-css.com.
About SNBL
SNBL is a Japanese global business corporation that works mainly in pre-clinical research,
pharmacokinetics and analysis, and translational research. SNBL is a business partner of PPD
regarding clinical research business in Japan and has jointly managed the joint venture PPDSNBL, a clinical research service provider in Japan, since 2015. Since being founded as
Japan’s first contract research organization in 1957, SNBL has supported clients by committing
to freeing patients from suffering by supporting drug development and improving medicaltechnology. SNBL is a listed company on the first section of the Tokyo Stock Exchange. For
more information, visit www.snbljapan.com.
PPD Contacts:
Media:
Holly Devine+1 919 456 6389
holly.devine@ppdi.com
Investors:
Thomas Wilson+1 910 558 6423
thomas.wilson@ppdi.com
SNBL Contact:
Media:
Masaya Suzuki+81 3 5565 6216
suzuki-masaya@snbl.co.jp