Audit and Inspection

Inspection from Health Authority

  • > 20 inspections by National HA to date
  • 1 Japanese PMDA
  • All without major findings 

 

Sponsor Audit

  • > 50 audit to date
  • All without major findings
  • Auditors from UK, US, Japan, Australia, Singapore, Hong Kong, etc.
  • A 2-day auditing by two Japanese auditors done on April 2008 in TTMC’s hospital

 

SMO Services
Feasibility
  • Delegated staffs for professional feasibility study in multiple sites
  • Site and PI recommendation
  • Consultation for site/investigator selection
  • Database Survey
  • PI interview
  • Trustworthy feasibility report
Site Coordination
  • Provide/Organize training & education programs for site staff
  • Establish and coordinate investigator team
  • Establish infra-structure for trials in hospitals
  • One-stop service for internal & external parties in a site
  • One-stop service for multiple sites within the network
Trial Conducting
  • Provide dedicated, full-time and experienced Clinical Research Coordinators on-site
  • Assist in visits and meetings arrangement & FU
  • Assist in accelerating the processof IRB if possible
  • Set up central recruitment campaign for trials
  • Assist in the preparation and conduct of monitoring, audit and inspection
A good SMO would benefit

Sites

  • Investigators and Sites need assistance
  • Well-established infra-structure & well-trained, dedicated staff are essential for quality trial conduct and performance
  • Good performance bring income and reputation to sites

Sponsor

  • Efficient and accurate feasibility response
  • Efficient contract process for multiple sites
  • Efficient pre-study preparation
  • Efficient subject recruitment
  • Good compliance and high quality of conduct
  • High retention rate for trial subjects
  • Efficient query resolution

Patients

  • In good hands
  • 24 hours, 7 days a week, professional care