Evidera, a business of Pharmaceutical Product Development, LLC (PPD), has entered into an exclusive collaboration agreement with Clinical Study Support, Inc. (CSS), a subsidiary of Shin Nippon Biomedical Laboratories Ltd. (SNBL), extending both organizations’ capabilities to deliver more robust consulting and analytical capabilities and creating a more complete geographic customer solution for clinical, real-world and 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 research organization 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 and implementation 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 health technology 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 from our 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 real-world 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 to expand 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 at booth #202 to provide additional information on the collaboration and their expanded capabilities in real-world and patient-centered research.