Japan

Why is Japan attractive for sponsors to conduct clinical trials?

• Pharmaceutical market: The third-largest market in a single country supported by aggressive new drug development and Universal Health Insurance.
• Drug development environment：
  • Well-established clinical development knowledge and environment including clinical investigational sites with well-trained site staff, SMO and regulatory processes. Those sites include university hospitals, institutional hospitals, public and private city hospitals and clinics as well which could provide timely study start-up and patient enrolment with highly eligible subjects in most therapeutic areas.
  • High quality of clinical data with a low drop-out rate in general.
  • The globalization of drug development has been well developed and more than 50% of clinical studies in Japan are Multi-Regional Clinical Trials (MRCT).
  • SAKIGAKE NDA process, a highly expedited evaluation process, is applicable for innovative drug candidates which will be launched first in Japan.
  • New chemical entities are being increased, particularly biotechnology products that are remarkable.
• Drug research environment: For early-stage clinical development, there are many key researchers and key opinion leaders who could conduct early-stage clinical research such as exploratory clinical study, clinical pharmacology study, or proof of concept study, which could provide the scientific rationale to proceed with further steps of clinical development toward approval and launch.
• Characteristics and culture: In general, the Japanese are well educated and keen to follow study rules and guidelines which is typically one of the key factors to obtaining a successful result of a clinical study.

Why is the EPSI and George Clinical alliance the CRO of choice for our sponsors in Japan?

1. Strength of EPS Group in Japan：
   • Well recognized as the TOP CRO partnership and site management organizations (SMO) in Japan through a more than 30-year history in Japan by stakeholders, sponsor companies, investigational sites and regulatory bodies.
   • No coverage limitation of therapeutic areas, stage of a clinical study, modality of project or purpose of a clinical study.
   • EPS Group companies cover all service needs, from first-in-man through to marketed products with a one-stop solution including CRO, SMO and CSO. The SMO covers more than 6,600 sites including those from key hospitals to clinics which could accelerate clinical studies sufficiently.
   • Well-trained and experienced staff who could lead and manage clinical study well as well as communicate with investigators and site staff effectively in a timely fashion.