After the FDA (or other regulatory agency for drugs marketed outside the U.S.) approves a new drug, companies may conduct additional studies, including Phase IIIb and Phase IV studies. Late-stage drug development studies of approved, marketed drugs may continue from several months to several years.

Phase IIIb/IV Studies: Phase IIIb trials, which often begin before approval, may supplement or complete earlier trials by providing additional safety data or they may test the approved drug for additional conditions for which it may prove useful.

Phase IV Studies expand testing of a proven drug to broader patient populations and compare the long-term effectiveness and/or cost of the drug to other marketed drugs available to treat the same condition.

Post-Marketing Studies: Post-marketing studies test a marketed drug in new age groups or patient types. Some studies focus on previously unknown side effects or related risk factors. As with all stages of drug development testing, the purpose is to ensure the safety and effectiveness of marketed drugs.

Post-Market Research Services that can be outsourced on CanBiotech include:

Health and Safety
  Adverse Reaction Assessment
  Post-Market Survelliance
  Safety Assessment
  Safety Protocol Development