The Need to Reduce Operational Complexity
The rise of targeted therapies has given researchers a deeper understanding of the mechanisms by which tumors grow, progress and spread. But the shift from the blockbuster, one-size fits all model towards niche indications have brought with them a huge increase in the complexity of study designs.
Mounting pressure from payers and regulatory agencies to demonstrate efficacy much earlier on in the drug development process has pushed biotech sponsors to find new and innovative ways to control costs while accelerating time to market for promising compounds.
We Understand What’s Important To You
Canadian sites are working hard to streamline their operations and commit to enrollment objectives because they understand how reducing your drug development cycle by three months can have a big impact on your critical number.
WHAT’S YOUR CRITICAL NUMBER?
Study Start-Up
Target First Site Opened (FSO)
- 50% Quicker Start-Up using Reverse Feasibility Program.
- Model clinical trial agreement template.
Patient Recruitment
Target First Patient In (FPI)
- Disease Incidence & Prevalence.
- Comparative Standard of Care to U.S.
- Patient Population comparative to U.S.
- Centralized Healthcare System means higher patient participation rates in Canada.
Regulatory Review
- 30-day default approval period.
- Fast-track approvals for compounds that demonstrate efficacy in early phase trials.
No Logistical Barriers
- Shared Language
- Time Zones
- Borders