Services
Osaiway commit to organize, conduct and complete successful clinical trials. Our services include:
Trial Management
Pre-study Site Preparation
Site feasibility studies
Site selection and evaluation
Collection of essential documents
Attending Investigator's Meetings
Documentation procedures, such as Trial Master File Management,central investigator file and investigator site file
Negotiation With Investigator Grants
Site Information and Training:
Staffing with trained and experienced CRCs
Patient recruitment support
Investigational Product (IP) Management
Training on IP, lab handling procedures, ECG, etc.
Logistics management
Site specific Standard Operating Procedures (SOP's)
On-site developmental briefing of Investigators and research team
Site Monitoring:
Patient follow up
Tracking CRFs
Regulatory compliance
Site Quality Assurance
Maintenance of Site documents
Resolution of queries
Research site liaison
Progress and status reports
Resolution of issues like Serious Adverse Event & DCFs within timelines
Study Close Out:
Patient follow up
Tracking CRFs
Regulatory compliance
Site Quality Assurance
Maintenance of Site documents
Progress and status reports
Resolution of issues like Serious Adverse Event & DCFs within timelines