Osaiway Research Pvt. Ltd

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