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Medicentres research department, established in 1991, has already proven to be a recognized player in pharmaceutical research in Canada. Prior to a new drug approval by the FDA (U.S.A.) or the HPB (Canada) these drugs are put through various "phases" of trials. In our family practice setting we are able to conduct phase 3 and 4 investigations in a wide variety of therapeutic areas. In the past the pharmaceutical companies looked to large institutions and universities to fulfill the study requirements, however now close to 80% of all trials are done at clinics similar to ours in North America. The term GOOD CLINICAL PRACTICE encompasses the ethical responsibilities we have as an investigative site, as well as the regulatory requirements that ensure the Rights, Safety and Well Being of the trial subject. This remains our most important consideration. The opportunity to participate gives our physicians and nurses a chance to diversify their practices/careers. It gives us insight to trends of future treatments and therapies. Our roles are vital in providing the quality Data necessary to allow the regulatory agencies to determine if the new drugs are Safe and Effective prior to their |
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