About the Author
Proxima CRO Team
Isabella Schmitt, MBA, RAC
Director of Regulatory Affairs
Ms. Schmitt has also served in additional regulatory affairs and clinical research roles in which she contributed to multiple regulatory submissions and clinical affairs projects across a wide range of indications.

Biopharma trials may include drugs and cell-based products.  They are rigorously controlled experiments or observations that are carried out on a new drug. They are conducted on human subjects to assess the drug’s safety, tolerability, and pharmacokinetics. In contrast to medical device trials, Biopharma trials are not specific on the selection of samples. A new drug or natural health product trial is first tested in the laboratory on laboratory animals to assess the drug's components and study its effects on the sample. If results obtained from the laboratory test shows potential benefits and no serious safety concerns it then proceeds to carrying out a clinical trial test on its effect on human beings. Biopharma trials occur in 5 stages:

  • Phase 0 (Early Phase I):  This phase aims to expedite the drug approval process. In most cases, Phase 0 studies are carried out on a small group of people (not
  • Phase I: This phase aims to determine the highest dose that can be administered to humans without serious side effects. The investigators spend several months investigating the effects of the drugs on about 15-30 people who have the underlying conditions. During phase 1, placebos are not administered to human subjects.
  • Phase II: Phase II involves a large group of volunteers (25 to 100 human subjects) who are living with the condition that the new medication intends to treat. Participants are usually administered the same dose found to be effective in the previous phase.  Investigator monitors the participants for several months to see how effective the drug is and to evaluate its safety. The data collected during this phase helps the investigator come up with the method for conducting phase III.  Placebos are not administered to human subjects in this phase.
  • Phase III: The purpose of phase III is to evaluate the safety and effectiveness of the new drug in comparison to existing medications for the same condition. Phase III usually involves a large number (100 or more) volunteers. Phase III are usually double-blinded, which means neither the doctor nor the participant knows the treatment protocol the participant is receiving (whether it is the new one or the standard one). This helps to eliminate bias during results analysis. Placebos may be administered during phase III.
  • Phase IV: Phase IV trials happen after the FDA has approved the medication. This phase can last for many years and involves thousands of participants. It takes an average of 10 years for a new drug to go from preclinical development to approval.
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