EP-SOGO provides on-site supports for efficient and proper implementation of clinical trials

As a Site Management Organization (SMO), EP-SOGO supports pharmaceutical and medical device companies to implement GCP compliant clinical trials utilizing its wide network of contracted trial sites (medical institutions).
EP-SOGO works with investigators, research nurses and administration staff to reduce the total clinical trial work load and improve the quality and speed.

• GCP (Good Clinical Practice)
  Regulations related to standards to implement clinical trials of medicines, issued by ICH and other competent authorities.
• CRC (Clinical Research Coordinator)
  Person in charge of supporting general clinical trial tasks including operations not requiring medical judgment, administration work related to clinical trials and coordination within operating teams under directions by investigators at sites.
• SMA (Site Management Associate)
  Clinical trial administrative staff (called Site Management Associate in Japan) is in charge of supporting proper and smooth procedure of clinical trials complying with GCP through creation, management and storage of documents required for clinical trial operations and IRB operation support.
• IRB (Institutional Review Board)
  Independent committee consisting of specialists for medicine, pharmacy, etc., to review subjects’ human rights or properness of clinical trials.
• Central IRB (single IRB)
  An IRB that conducts a single review for participating sites of the multi-site study