Manage Contracts, Support Regulatory Inspection and More

CMIC provides Site Management Associates (SMAs) to support Japanese clinical trial preparation and refer clinical trial sponsors to first-rate facilities. Our SMAs help perform administration tasks for medical institutions without language and cultural barriers. SMAs prepare sites for clinical trials, provide IRB submissions, support IRB reviews, manage invoices, prepare documents and support audit/regulatory inspections. As part of your site and patient support team, our SMAs perform wide range of administration tasks needed for Japanese regulatory approval.

Our Edge in Clinical Site Administration

Comprehensive operational support for clinical support

  • We introduce candidate medical institutions which can be matched for each trial to clinical trial sponsors
  • Our SMAs support clinical trial preparation
  • We prepare and manage documents in alignment with GCP

Services

  • Request initiation of clinical trials by medical institutions / prepare for clinical trials
  • Prepare / conclude clinical trial contract
  • Manage invoices of clinical trial
  • Prepare / manage essential documents
  • Arrange IRB / support IRB proceedings
  • Manage / support IRB review of documents
  • Support audit / regulatory inspection

Site Management Support

Clinical Research Coordinator (CRC)