Contract Medical Affairs, Clinical Trial (CMACT)
About Clinical Research Monitors
(CRAs responsible for post marketing survey)
Clinical research is different to the clinical trials that pharmaceutical companies conduct in the process of developing new drugs; it is a type of clinical study, focused on human test subjects, performed for the purpose of improving prevention, diagnostic and treatment methods, understanding the cause and pathology of diseases, and improving the quality of life for patients. The main work of clinical research monitors is to visit the medical institutions where clinical research is conducted, to check that the research is appropriately performed in accordance with applicable rules, and to collect data.
Most important objective of clinical trials
Recruitment of patients to participate in clinical trials is performed under very strict conditions; only patients satisfying very narrowly defined eligibility criteria can be accepted. In this way, the question of whether an unapproved compound can produce the desired effect can be decided with sufficient precision. The substance being trialed, may or may not be approved as a pharmaceutical product, but even if it is, it starts life like a “newborn baby.” For example, a blood pressure drug may be approved as a pharmaceutical product if it is found in the clinical trial to have the effect of lowering blood pressure and if it is proven to have no major safety issues. The most important consideration for patients with high blood pressure, however, is that they do not suffer a potentially fatal event such as a myocardial infarction or stroke as a result of lowered blood pressure.
Drawing out the full potential of pharmaceutical products
Clinical research is conducted to pursue the true value of a pharmaceutical product by verifying its desired effect. Once the “baby” pharmaceutical product becomes a splendid, full-fledged “adult”, it may be recommended by medical guidelines, making it easier for clinical physicians to prescribe it, and easier for large numbers of patients to benefit from it. In addition, enhancing the value of new drugs during the period of patent protection allows the pharmaceutical company to recoup its R&D costs more quickly and accumulate funds for further development. Success promotes the development of new drugs and enables the needs of patients and other stakeholders in the pharmaceutical industry to be met sooner.
Work performed by Clinical Research Monitors
Each monitor is usually in charge of one project, involving 10 to 20 medical institutions. According to the scale of the project, a team of monitors might consist of anywhere between several and dozens of monitors. The main tasks of a monitor are (1) To select medical institutions for conducting the clinical research; (2) To explain the planned research to physicians and conclude contracts with them; (3) To coordinate patient recruitment to ensure that it progresses smoothly; (4) To check that research is being done according to applicable rules; and (5) To collect data involving checking whether there have been any side-effects or conflicting data. Compared to CRAs in clinical trials, Clinical research monitors deal with a larger number of medical institutions and have communication with them by telephone and email more often than by face to face conversation.
Mission of Linical’s Contract Medical Affairs Business
Linical was one of the first companies in the CRO industry to deliver their services by deploying clinical research monitors on-site. As a company, we did this because we wanted to offer an optimized service for clinical research, which operates according to different rules than clinical trials. Basically, while clinical trials are conducted according to GCP-type rules, clinical research must comply with ethical guidelines. The clinical research environment is changing significantly due to various compliance issues that have occurred in recent years, resulting, for example, in the ethical rules being enshrined in law. Linical grasps these kinds of trends quickly and adapts to them flexibly. We pursue our work with the goal of becoming an industry leader in high ethical standards.