Monitoring in clinical trial
The contract is signed, the research is in full swing. However, who and how guarantees the sponsor’s confidence that his funds were not invested in vain? The sponsor should take care about this before starting the trial, selecting who will be engaged in monitoring the project for safety and compliance with all formal procedures. These can be sponsor staff, contract research organizations or independent experts.
To begin with, it is necessary to understand what monitoring in clinical trials is. Monitoring of a clinical trial is a process to monitor the progress of a clinical trial to ensure that it is conducted, documented and reported to the appropriate authorities under the Protocol, the GCP rules, standard operating procedures and the requirements of official authorities. All these procedures are called “monitoring of clinical research”, and professionals who provide these services are called monitors or CRA (Clinical Research Associate).
A clinical research specialist or CRA (Clinical Research Associate) is a very responsible, prestigious and fairly well-paid profession in the pharmaceutical market. CRA is researching the desired and side effects of medications, including new medicines and those which are already on the market. However, this is only a small, but the main part of a huge range of his duties. In different companies, this post may be called differently: as a controller of clinical studies (or tests), as an administrator, as a research assistant or as a coordinator.
As the executive director of X7 Research Dmitry Kryuchkov notes, the clinical research monitor should be well versed in various therapeutic areas, understand the methods of examining patients, including high-tech methods. In addition, it is necessary to know and understand the rules of good clinical practice (GCP ICHE6 standard), to understand Russian and international legislation in the field of organizing and conducting clinical trials.
Candidates for this position are indeed subjected to strict requirements: necessarily higher medical, less often – pharmaceutical education, knowledge of English. Companies also require the applicant to have excellent communication skills in written and spoken language, both in Russian and English, the ability to establish relationships with people, the ability to work in a team and attention to detail. A mathematical mentality, a commercial vein, administrative and organizational skills are also welcome. This work requires high self-organization and the ability to quickly learn information. It is highly desirable to have previous experience in the same field, which may include medical practice, drug sales, clinical work in the laboratory, work with clinical data, pharmaceutical research.
In accordance with the consistent development of any clinical project, the monitor can also identify several main stages of work: before the clinical part, during the study and after the completion of the clinical part of the study.
So, at the stage of preparation for clinical research, the monitoring specialist selects and instructs doctors, consultants, and testers qualified for the trial. Also, his duties include the preparation of research laboratories and centers – their provision with the necessary equipment and materials.
During the clinical stage, monitoring of the trial is carried out on the shoulders of the monitor, including regular visits to research centers, collection and verification of patients’ medical records, and solving current problems, which, incidentally, may be of the most unforeseen nature.
At the end of the trial, the clinical study monitor closes the research centers, and also participates in the preparation of a technical test report together with a specialist in the statistical processing of medical data.
It is worth noting that the work of a clinical research specialist is very different in different companies. In some companies, CRA participates in the process from start to finish – from discussing the trials with the doctor who submitted the idea, and from developing a protocol till writing the final report. In other companies, the clinical trial project is developed by a consulting physician, and the specialist’s function is to collect data on the progress of the trials.
From all the above, it is obvious that the work of the CRA is not only complex, but also interesting, diverse. Such specialists should combine both the soft skills inherent in highly qualified managers and be as concentrated and focused as possible in order to avoid mistakes in filling out and verifying various official documents. It is the professionalism of the monitor that guarantees the trial safety and compliance with formal requirements.
At X7, you’ll find only superbly trained and seasoned CRAs. Our CRAs have been involved in cardiology, neurology, rheumatology, oncology, pulmonology and many other areas of medicine. In addition, we have monitors available with experience in target nosology. Thus, you can be sure of the quality of your X7 Research specialist.