Vantage BioTrials
Vantage BioTrials is a Canadian Contract Research Organization (CRO) specializing in comprehensive clinical trial management services. They implement Risk-Based Management and Quality by Design (QbD) methodologies to accelerate studies and reduce risks. The company supports the development of new therapies through expertise in trial design, patient recruitment, site management, and regulatory compliance, with a focus on patient safety and regulatory standards. Vantage BioTrials collaborates with pharmaceutical sponsors, biotech, and research institutions to ensure successful trial execution and improved outcomes. Recognized for operational excellence, innovation, and client focus, the company has received multiple awards including 'Biotechnology CRO of the Year 2018 – Quebec' and 'Most Client Focused Clinical Trial Management Firm – Canada.' They have successfully passed Health Canada inspections and are active in industry conferences and publications.
Industries
Nr. of Employees
small (1-50)
Vantage BioTrials
Dollard-des-Ormeaux, Quebec, Canada
Products
Clinical Trial Management
Comprehensive clinical research organization (CRO) services focusing on risk-based clinical trial management, multinational study execution, and regulatory compliance for pharmaceutical, biotechnology, and medical device sponsors.
Clinical Trial Management System (CTMS)
A web-based, validated, and secure system that provides project owners and leadership with real-time access to trial status, key KPIs, critical trends, and reports.
Cardiology Trial Management Services
Full-service cardiology trial management from early-phase studies to real-world evidence, supporting drug, device, and combination therapies.
Phase IV Clinical Trial Services
Late phase programs and post-marketing studies designed to address regulatory and risk management considerations, create meaningful data reports, and provide disease or product information.
Phase I Clinical Trial Services
Comprehensive early-phase trial management services including study design, feasibility assessments, protocol development, site selection, and risk-based clinical monitoring for bioequivalence and Phase I trials.
Phase II-III Clinical Trial Services
Late-phase study management services utilizing highly-skilled clinical research consultants across North America and Latin America, offering comprehensive oversight from study design to biostatistical analysis.
Clinical Trial Management
Comprehensive clinical research organization (CRO) services focusing on risk-based clinical trial management, multinational study execution, and regulatory compliance for pharmaceutical, biotechnology, and medical device sponsors.
Clinical Trial Management System (CTMS)
A web-based, validated, and secure system that provides project owners and leadership with real-time access to trial status, key KPIs, critical trends, and reports.
Cardiology Trial Management Services
Full-service cardiology trial management from early-phase studies to real-world evidence, supporting drug, device, and combination therapies.
Phase IV Clinical Trial Services
Late phase programs and post-marketing studies designed to address regulatory and risk management considerations, create meaningful data reports, and provide disease or product information.
Phase I Clinical Trial Services
Comprehensive early-phase trial management services including study design, feasibility assessments, protocol development, site selection, and risk-based clinical monitoring for bioequivalence and Phase I trials.
Phase II-III Clinical Trial Services
Late-phase study management services utilizing highly-skilled clinical research consultants across North America and Latin America, offering comprehensive oversight from study design to biostatistical analysis.
Services
Program and project management across all trial phases including oversight, KPI tracking, QbD-based risk mitigation and global site management.
Combination of on-site and centralized monitoring, metric interpretation and proactive interventions to maintain data integrity and participant safety.
Medical oversight for clinical studies, SAE processing and narrative preparation, safety report submissions and DSMB management.
Statistical consulting, SAP development, sample size calculations, Bayesian analyses, clinical data management and data quality oversight.
Preparation of protocols, clinical study reports, investigator brochures, regulatory submissions, abstracts and scientific manuscripts.
Independent audits, vendor audits, gap analysis, development of quality manuals and SOPs, and regulatory inspection readiness programs.
Program and project management across all trial phases including oversight, KPI tracking, QbD-based risk mitigation and global site management.
Combination of on-site and centralized monitoring, metric interpretation and proactive interventions to maintain data integrity and participant safety.
Medical oversight for clinical studies, SAE processing and narrative preparation, safety report submissions and DSMB management.
Statistical consulting, SAP development, sample size calculations, Bayesian analyses, clinical data management and data quality oversight.
Preparation of protocols, clinical study reports, investigator brochures, regulatory submissions, abstracts and scientific manuscripts.
Independent audits, vendor audits, gap analysis, development of quality manuals and SOPs, and regulatory inspection readiness programs.
Expertise Areas
- Clinical trial management (Phase I–IV)
- Risk-based monitoring and Quality by Design
- Adaptive trial design and interim simulation
- Biostatistics and clinical data management
Key Technologies
- Electronic data capture (EDC) systems
- Clinical Trial Management Systems (CTMS)
- Interactive Web Response Systems (IWRS)
- eTMF and computerized system validation
News & Updates
Vantage BioTrials virtualized its operations to reduce waste and improve efficiency, offering remote working conditions and digitized SOPs and policies.
The company adopted Smartsheet to manage its growing demand for early/late phase and medical device trials, ensuring accuracy, flexibility, and real-time data access.
Completed a Phase IV observational study in adult HS patients, measuring real-world effectiveness of adalimumab.
Partnered with Laurent Pharmaceuticals to manage a Phase 2 trial of LAU-7b for COVID-19 in the US, approved by the FDA.
Participated in the April 2025 conference in Boston, discussing trends in clinical development.
Received the award from Acquisition International Magazine in December 2017 for client focus.
Vantage BioTrials virtualized its operations to reduce waste and improve efficiency, offering remote working conditions and digitized SOPs and policies.
The company adopted Smartsheet to manage its growing demand for early/late phase and medical device trials, ensuring accuracy, flexibility, and real-time data access.
Completed a Phase IV observational study in adult HS patients, measuring real-world effectiveness of adalimumab.
Partnered with Laurent Pharmaceuticals to manage a Phase 2 trial of LAU-7b for COVID-19 in the US, approved by the FDA.
Participated in the April 2025 conference in Boston, discussing trends in clinical development.
Received the award from Acquisition International Magazine in December 2017 for client focus.