As a comprehensive clinical trials methodology and co-ordination centre, we partner with sponsors and steering committees to design robust methodologies and deliver efficient trial operations tailored to the study’s research objectives.
We provide comprehensive expertise across the full life cycle of clinical trials - from protocol development and regulatory submissions to study execution, site management and closeout.
Our commitment is to uphold the highest quality standards while ensuring full compliance with Good Clinical Practice (GCP) and all applicable regulatory requirements. Our team includes experienced project managers, research assistants and methodological experts.
Our services include:
- Grant writing support and budget planning
- Site feasibility and selection services
- Protocol development
- Methodological consultation
- Project and site management
- Development of project plans
- Regulatory consulting and submissions
- Safety event adjudication
- Organizing data safety monitoring boards/committees
- Expedited serious adverse event (SAE) reporting
We have expertise in:
- Therapeutic drugs
- BiologicsMedical devices
- Natural health products
- Observational studies
- Longitudinal registries
- Qualitative studies
- Non-pharmacological interventions
- Multi-centre, national & international studies
