Phase I Trials: includes initial studies to determine the metabolism and pharmacological actions of drugs in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness. At this stage, drugs are tested in a small group of healthy volunteers to determine the drug’s activity.

Phase II Trials: includes controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks. These trials are aimed at identifying the optimal dose to be used in Phase III trials and, ideally, they identify drugs that will not make it through the next phase of testing.

Phase III Trials: includes expanded controlled and uncontrolled trials after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug and provide an adequate basis for physician labeling. These studies, which take several years, can involve thousands of patients at multiple trial centers. They are aimed at definitively determining the drug’s effectiveness and its side- effect profiles.

Pharmacogenomics: A key tool for the design and interpretation of clinical trials. It contributes to a precise definition of a disease. It has the ability to correlate drug response to genetic markers and predict dose response and adverse events in some cases. It allows for the stratification of patient populations. The potential benefits include reduction of drug development time due to the demonstration of efficacy in specific populations; the optimization of clinical utility by linking sub-types and efficacy; and reduction of time to market.

Clinical Trial Services that can be outsourced on CanBiotech include:

Clinical Research Organizations
  Clinical Trial Recruitment
  Complete Clinical Trial Management
  Data Management and Biostatistics
  Medical Writing
  Pharmacogenomics
  Preclinical Development
  Project Management and Clinical Monitoring
  Regulatory
  Study Design and Development

Contract Research Organizations
  Contract Manufacturing
  Contract Pharmaceutical
  Contract Research

Data Analysis and Management
  Bioinformatics
  Biostatistics
  Protocol Design

Genomics
   Pharmacogenomic Analysis

Regulatory
  Compliance
  Licensing
  Monitoring Clinical Trials
  Registration
  Regulatory Submissions

Compliance
  FDA-U.S.
  GCP
  GLP
  GMP
  HPB-Canada