Clinical Trial Services and Management

Clinical Trial Services and Management

Clinical trials hold enormous potential for benefiting patients, improving therapeutic regimens and ensuring advancement in medical practice that is evidence based.

The purpose of a clinical trial is to find a new and improved way to treat, prevent, or diagnose different types of illness.

  • A clinical trial is defined as the systematic study of new drug in human subject to generate data for discovering and/or verifying:
  • The clinical pharmacological (including pharmacodynamic and pharmacokinetic) effects and/or adverse effects
  • With the objective of determining safety and/or efficacy of the new drug

Clinical trials are split into four separate phases, all of which involve testing a newly developed drug on an increasing number of patients and/or volunteers:

Phase I : This early phase is crucial in determining whether a drug is safe enough to proceed onto later phases. It determines a safe dosage range for humans and is the first opportunity to discover and evaluate any side-effects. Healthy volunteers largely participate.

Phase II : The drug's safety is further evaluated and any side-effects are closely monitored and analysed. This is the stage in which the drug's effectiveness will really become apparent.

Phase III : This phase is carried out on a very large scale. Surprisingly, the drug is most likely to fail during this phase. The effectiveness, safety and side-effects continue to be monitored. It's also a chance to compare it to similar drugs already in the market.

Phase IV This phase is carried out after the drug has entered the pharmaceutical market and involves real world data monitoring. Phase IV trials take place over an indefinite period in order to collect vital information about side-effects associated with long-term use.