Our many years of experience facilitate comprehensively managing the research in accordance with the requirements of Good Clinical Practice and all applicable laws.
First Phase Research:
Safety evaluation of a medication.
Usually carried out on a small number (20 to 100 people) of healthy volunteers over a few months.
Assesses how the drug works in the human body:
Second Phase Research:
Testing effectiveness of the new medication after safety has been determined.
Involving several hundred patients, this phase can last from several months to a few years.
Third Phase Research:
The medication is tested on several hundred to several thousand patients to more precisely determine the effectiveness of the drug, benefits of therapy, and the range of possible adverse drug reactions.
Favorable results of third phase research make it possible to receive post marketing authorization of the drug or broaden the indications for its use. This research usually lasts several years.
Fourth Phase Research /Marketing:
During the fourth phase of research, pharmaceutical companies examine the following:
• Compare the medication with the others existing on the market
• Monitor the long-term effectiveness of the medication and its influence on the quality of the patient’s life
• Much of the research is to determine actual benefits relative to other traditional and alternative therapies