Category: Clinical Research

Each and every drug that is made available to the public in the market necessarily undergoes certain testing procedures. This process of medical drug testing is popularly known as clinical trials. This step is necessary to understand the effect of any new drug on medical volunteers. The whole procedure is conducted under the vigilant eyes of scientists or medical researchers who constantly develop new drugs.

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In the nascent stage of Risk Based Monitoring, it started on-site. But, with the passage of time, the focus shifted towards centralized monitoring. Centralized monitoring for clinical trials is a preferred approach in the present day scenario. With centralization, the benefits of standardization, an organized approach and better control automatically flow in. During the trial delivery, it helps to deliver a result with utmost accuracy and there is no compromise with the patient safety and data quality. On the other hand, on-site monitoring is totally based on source data verification.

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Clinical trials can result in several complications related to the medical conditions of the participants involved in a clinical trial. During a clinical trial, these kinds of situations or events might happen. It is important to have a proper segmentation of events so that a quick and effective management plan can be implemented immediately. There are different reporting processes that need to be followed in different events. Two most common events in a clinical trial are Adverse Events (SE) and Serious Adverse Events (SAE).

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With the focus and emphasis on Risk Based Monitoring, the role of the clinical research associates is changing. More than one-third of the clinical trials done today, use the elements of risk-based monitoring. Site-based monitoring had always been an essential component in clinical trials. However, with centralized monitoring being a preferred approach, there is change in the role of the clinical research associates.

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Drug development and clinical research are evolving. Researchers are making every effort to improve data safety and integrity. Thus regulators in the US and EU have called for clinical research to shift from the practice of 100 percent source data verification, which is time-consuming and a costly process to risk-based monitoring.

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Medical narratives are an important part of the reports prepared for any clinical trial. These are written to provide a brief description of events occurring during the trials. Narratives are often very short (not more than 100-150 words). Narratives can be written as part of the end report on trials or in case of special events where a participant leaves the trial due to severe adverse events.

“For physicians and other healthcare professionals, medical writers are generally involved in writing textbooks, preparing online study material, power point presentations, Continued Medical Education (CME) programs etc.   For patients, medical writers are routinely involved in developing education material. This generally falls under medico-marketing writing in pharmaceutical companies” source jli.edu.in

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Clinical trials involved during a drug development are very costly. Some research projects require multiple monitoring, which increases the costs. Remote monitoring is less expensive, but cannot meet the accuracy level in some research projects. Thus, researchers have started the use of Risk-based Monitoring which is a popular and hassle free way to perform clinical trials.

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During the process of drug development, clinical trials can be significantly expensive. There are several studies that require multiple monitoring and visits across several sites. While conventional monitoring techniques are responsible for major costs, the additional travel costs are often expensive. Remote monitoring, however, offers a better and less expensive choice.

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Participating in Clinical Trials can be of great help for the researchers trying to develop better health care products.  It can also be rewarding for the participants. Yet, there is only a very slim percentage of the population around the world that participates in Clinical Research.

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One of the major challenges in the pharmaceutical industry is the increasing cost of clinical trials. The cost of clinical trials has increased by more than 50% in the last five years.

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Standard Operating Procedures (SOPs) in Clinical Trials are the standard documents that define the procedure, which must be followed to ensure that standards are followed while carrying out research.  These SOP’s help the research teams, as recommendations for conducting research in the appropriate manner. They clearly outline the step by step procedure to be followed on various topics concerned with clinical research in question.

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In olden times, narratives played a vital role in the medical industry. The recorded history and present illnesses of patients, their diagnostics, care and recovery were shared by medical experts, research centres, doctors and the patients. However, modern medicine and therapy changed everything. People started ignoring narratives and believed in facts or findings.

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Clinical trials are complex and require project management. Project management is applied in various fields as it helps keep the entire process of a project well structured. Reports, documentations, guidelines are created, that give a clear idea about the steps carried during each process. Before the advent of project management, many trials have failed because the complexity of the clinical data was not handled systematically.

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Applying statistical methods to calculate the data in healthcare and medicine industries involves parameters, variables, equations, and different types of quantitative data. This data is used to analyze the effects of the drugs and its impact on the human population. Reports that provide information on the new and current drugs need to provide these statistics to know which drug is in demand in the market. These analysis are used to make business decisions in this industry.

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The measure of how the drug affects the physical, mental, cognitive, and emotional state of an individual denotes the clinical endpoint. In any clinical research of a disease the endpoints of this research includes, reoccurrence of the disease after using the drug, any other symptoms, death rate post drug usage, rate of survival of disease post using the drug, etc. The overall response during and after the usage of the drug also counts as the endpoint.

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