Sage Biotech Inc. is honored to be your partner in introducing and delivering new pharmaceutical drugs and medical devices. We deliver a variety of clinical development services customized to fit your objectives, whether you need a single function across several drug programs, a range of functions within a single therapeutic area, or introducing new novel medical devices.

Choose Sage Biotech Inc. and you can benefit from scalable capacity, dedicated staff, the ability to reduce fixed costs and accelerate timelines. Our team of experts will rapidly respond to your needs as they evolve.

We bring together the right balance of R&D, best business practices and quality manufacturing to introduce and deliver novel pharmaceutical products and medical devices.

Study design

• Protocol development
• feasibility checklist
• Assist with enrolment, ethics and compliance
• Developing Standard Operating Procedure
• Site initiation
  • Research Site and Investigator Selection
  • Investigators’ Meetings
  • Personnel Training
  • Site Initiation
  • Site Set-up
• Site Monitoring
  • Complete Monitoring Activities Associated with Phase II-IV of Clinical Research
  • Source Document Review and Data Verification
  • Checking Internal Consistency of CRF Data
  • Data Query Management
  • Issuing Data Alerts to CDM
  • Monitoring of Enrollment Rate and Patient Eligibility Criteria
  • Training
  • Site Closure

Project Management

• Study Coordination
• Budget and Time Management
• CRAs and Project Team
• Progress Reports
• Medical Monitoring and Reporting of SAEs
• Statistical analysis planning
• Subject randomization

Data Management

• Creating database at your site or ours and according to your specifications
• Detailed case report form (CRF) Design and Review
• Double-Data Entry
• Electronic Data Capture projects
• Data listings or reporting to your requirements
• Comprehensive Data Validation
• Data Quality Assurance
• Dictionary Preferred-Term Coding
• Data Management Training and Consultancy
• Data Analysis
• Data Management Reporting
• Data Review Meeting
• Database Locks with Associated Documentation
• Database transfer in Sponsor defined formats with detailed documentation

Medical writing

• Investigator’s’ Brochures
• Protocols
• Integrated Clinical and Statistical Reports
• Manuscripts
• Submission to journals
• Posters and Publications
• Translation services
• IND Preparation and Administration
• Regulatory Submissions
• EDC Compilation and Administration
• ICH-compliant Documents