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Phase Ib-III Trials

Minimize your time to market

When bringing a therapy to market, clinical phase research is the biggest R&D investment in terms of both time and money. Biorasi is fast – faster than other CROs. When your innovation is ready for clinical trials, your CRO needs to be prepared and set for a successful start.


 

Biorasi is passionate about rapid, high-quality execution of phase Ib-III clinical trials through,

Patient-centric

Recruitment Strategies

On-demand

Data Infrastructure

Flexible

Project Resourcing Models

to meet the challenges of even the most difficult to execute programs.

Flexible solutions from start to finish


Phase 1b

Flexible solutions from start to finish


All our solutions are available as a flexible functional service provision (FSP) for partners who need more versatility in their outsourcing model.

Phase 1b

We support the full life cycle of clinical trials in patient populations, from initial regulatory enablement through submission for marketing operations. Explore our available solutions.

 

Medical Writing

  • Protocol Synopsis
  • Protocol
  • Investigator’s Brochure
  • IMPD
  • Informed Consent Form
  • Patient Narratives
  • Clinical Study Report
  • Clinical and Nonclinical Summaries
  • Pre-Submission Preparations (e.g., pre-IND, Q-Sub, etc.)

Regulatory Support

  • Regulatory Strategy
  • Pre-Submission Meetings (e.g., pre-IND, Q-Sub, etc.)
  • Global Regulatory Submissions
  • IRB, Local and Central Ethical Committee Submissions
  • Regulatory Reporting (DSUR/PSUR, etc.)

Project Management

  • Global Program Coordination and Oversight
  • Project Transition and Rescue Management
  • Vendor Mobilization and Management
  • Project Plans
  • Investigator Meetings and Trainings
  • DMC Support

Clinical Management and Monitoring

  • Site Feasibility and Qualification
  • Site Contracting and Payment Administration
  • Site Initiation, Monitoring and Closeout
  • Central, Remote, and Virtual Clinical Trial Monitoring
  • Risk-Based Monitoring
  • Site Audit Support

Patient Recruitment

  • Study Marketing and Advertising
  • Community Engagement
  • Patient Navigator

Medical Monitoring

  • 24/7 Medical Support and Guidance
  • Protocol and Plans Review
  • SAE/SUSAR Review and Assessment
  • Medical and Clinical Data Review
  • CIOMS/MedWatch Support

Data Sciences

  • Database Build, Validation and Testing
  • System and User Management
  • Data Cleaning and Query Management
  • Database Reconciliation and Lock
  • CDISC Standardization
  • Statistical Programming and Analysis (Tables, Listings and Figures)
  • Adaptive Designs and Power Analyses
  • CSR, ISS/ISE, DSUR, etc. Support

Safety and Pharmacovigilance

  • Safety Database Management
  • Case Processing
  • Safety Reporting (SUSARs)
  • Medical Coding

Quality Assurance

  • Site and Vendor Audits
  • Study and Trial Master File Audits
  • Inspection Support
  • Risk Assessment
  • Risk Management