Phase II Studies
Much like early phase clinical research, Phase II trials evaluate the safety of nutraceutical products. The difference with Phase II clinical trials is that they also test the effectiveness of the product and tend to be performed with larger groups of participants. Unlike pharmaceutical drug trials, nutraceutical clinical trials can begin at Phase II, as long as you can provide scientific evidence that supports that the nutraceutical is safe for human use.
Types of Phase II Studies include:
- Proof of concept studies (Phase IIa)
- Dose-Response or Dose-Finding Studies (Phase IIb)
Phase III Studies
Phase III studies are typically much larger than Phase I and II trials and can include participant enrolment at different sites or even in different countries. Phase III studies are also often used to confirm the effects shown during a Phase II trial, provide more safety data, and serve as the basis for product labelling. Should a sponsor look to make a disease prevention claim, for example, at least one Phase III study would be needed to substantiate this claim for natural health products (NHPs).
Recruiting for Phase III studies is often challenging due to the need that these trials often require multiple sites with a high number of participants needed. The success of these trials depends on insights gathered using high-quality early phase data. An accurate protocol design based on feasibility studies and phase II trial data is key to mitigating your Phase III trial risks.
Our Phase II-III Clinical Trial Services Include:
- Data management
- Feasibility studies
- Safety and pharmacovigilance
- Medical writing
- Project management
- Protocol Design
- Case report form design
- Regulatory affairs
- Site management
- Clinical Site Monitoring
Contact us for assistance with your Phase II-III clinical trials