Late Phase
Evidence Meets Opportunity in Late Phase
You’ve spent hundreds of millions of dollars and years bringing your product through the drug development process. Now you face multiple opportunities – and possibly more requirements – to demonstrate safety and effectiveness in larger populations. But your budget isn’t endless.
With Quintiles, you get the insights, experience and efficiencies to optimize your post-marketing research investment. Our phase IIIb clinical trials staff and our phase IV clinical trials teams understand there are many study and design variables, so we align and customize our processes to deliver on your objectives cost-effectively. We use:
- Multidisciplinary, data-driven study design and recruitment approaches
- Flexible delivery models and proven processes
- Dedicated, specially trained late phase project managers
- Experts in health outcomes, epidemiology, biostatistics and post-marketing regulations
Phase IIIb Clinical Trials and Phase IV Clinical Trials Services
- Post-marketing safety surveillance
- Additional indication or label expansion trials
- Comparative effectiveness; outcomes research
- Observational; registries
- Risk management programs/REMS
