On the 20th of May 1747, more than two hundred and sixty years ago, the first clinical trial was started by the famous Scottish physician James Lind who was trying to find a cure for scurvy. The trial resulted in the revolutionary finding of the therapeutic action of citrus in patients with scurvy. Since then, the 20th of May is globally celebrated as an International Clinical Trials Day.
OCT is happy to join the celebration and commemorate James Lind who has started what we are proud to continue together with our colleagues all over the world, helping bringing new efficient medicines to a global population.
Clinical trials are research studies requiring involvement of people. The main goal of any clinical trial is to provide impartial and objective evidence of safety and efficacy of one or another kind of treatment in order to get further approval and permission to use the drug to treat patients. People, or patients, are the core element of any clinical trial, and their safety always remains the priority during the investigational process. This fundamental notion underlies one of the thirteen core principles of any clinical trial, which are described by the International Conference on Harmonization — Good Clinical Practice (ICH-GCP) and are applied to any type of clinical trials.
Clinical trials can be categorized according to different criterias, but generally the following types of trials are distinguished: bioequivalence and therapeutic equivalence studies; early stage (phase I/IIa) trials; pivotal (phase IIb/III) trials ; post-approval / post-authorization / post-marketing / phase IV studies. Also, according to the objectives of the clinical trials, they might be prevention trials, treatment (interventional) trials or diagnostic and screening trials.
Moreover, clinical trials can be described as randomised trials, open label trials or blind/double-blind studies, multinational, single centre or multi centre trials, or placebo controlled trials. These terms describe the way that the trials are organized, which influence the subjects of the studies.
OCT experienced team works strictly in accordance to the GCP standards and are eager to provide the full range of services connected with clinical trials conduct in Russian Federation, Central and Eastern Europe. We have a solid experience in organizing trials of all the above-described types and phases, as well as in providing supporting services that are vital for a successful and high quality clinical trial. Thus, we provide any kind of support for the turn-key projects of our clients, including consulting and conducting GCP trainings, medical writing and preparation of documents for clinical trials approval application, data management and statistics, as well as the new service recently introduced by our team – support in drug registration in Russia.