Audit and Inspection
Inspection from Health Authority
- > 30 inspections by National HA to date
- 1 Japanese PMDA
- All without major findings
Sponsor Audit
- > 70 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