Category: Clinical Research

Clinical research certification is widely recognized to seek numerous job opportunities in different clinical research fields. Students seek for hands-on experience along with high-quality reference materials to pursue their role in the relevant clinical research field. The basic understanding of clinical trial concepts and the types of approaches should get the hold of talented candidates. Those with comprehensive knowledge in a particular clinical trial method will have ample opportunities for externship programs. Students with refined knowledge in proper  clinical trial processes shall pursue the title of certified clinical research professional.

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Clinical trials are research studies which try to determine if a   medical strategy, treatment or device is safe for humans. This research is very scientific it protects its volunteers or patients from any hazards to their health and brings out better study results. Clinical research starts in the laboratory and if it shows promising results then the researchers proceed to experiment on animals and finally, the success here leads them to make clinical trials with humans. The main findings of a clinical research are as follows

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Ehealth is a word used to characterize not only “Internet medicine”, but also virtually everything related to computers and medicine. According to Intel, e-health is “a concerted effort undertaken by leaders in healthcare and hi-tech industries to fully harness the benefits available through convergence of the Internet and health care” .

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Clinical Research or Clinical Trial Research is very important to medical science as it is the knowledge received from these studies, the data received from these ventures that help in the opening of new avenues in the field of advanced medical treatment. Various organizations, physicians, medical institutions and pharmaceutical companies may be some of the sponsors of these clinical trial researches to name a few.

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The world is witnessing an era of digitization of health care sectors where it has become viral with innumerable methods contributing to patient welfare schemes. As the digitization of healthcare sector proves to be dynamic according to the latest trends, a lot of countries have already started implementing it in the health care sector market. The investment by health care providers ranges from providing vast infrastructures to introducing mobile solutions to the market. While the arrival of new information powered healthcare reality increased the expectations of nurses and doctors, the emergence of eHealth has been widely recognized as the democratization of healthcare that meets the challenges caused by various factors in healthcare such as the epidemic of chronic and non-communicable diseases, dramatic costs involved in healthcare and an aging society.

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Standard Operating Principles (SOPs) followed in a business organization deal with the uniformly written procedures woven with detailed instructions framed to register practices, routine operations and processes. SOPs play an integral part in clinical research where the standard practices and daily process are handled for the execution of research tasks with respect to the institutional, federal and state guidance.

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In the futuristic development of clinical research, technology has been a phenomenal source to achieve the unprecedented landmark in diagnoses and treatment. In an industry where the lack of creativity was playing a terrible role, the new era of scientific breakthroughs brought in new opportunities to savor clinical trials. The fast growing technology-enabled clinical research organizations stretch out their expertise to create new innovation in patient care and connectivity.

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Clinical data management is an extremely vital part in clinical research that deals with the gathering of required data, ensuring its integrity and therefore making it available at appropriate quality and cost. With the aid of clinical trials, clinical data management creates a high-quality and reliable data which also proves to be statistically sound in nature.

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Informed consent is an approval given by the patients for the concerned health care professionals before they start any clinical trials. The Case Report File (CRF) will be used significantly in the clinical trial research which collects the data from each participating site. Likewise, ICF (Informed Consent Form) should be written, signed and dated while submitting for approval.

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Clinical trials are part of a long and careful research process that delves into testing which medical approaches and new pharmaceutical products work best for different groups of people affected by particular medical conditions. Since their purpose is to perform research and live human beings are involved in the research as participants, the trials need to follow stringent scientific standards. They also need to be monitored so as to ensure the safety of the human participants.

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The focus on clinical trials has always tended to be more towards the pharmaceutical or procedural or organizational aspects such as sponsor responsibilities, regulatory approval process, drug safety and efficacy, drug development, marketing and sales tactics. Apart from these, patient safety is also ensured stringently, especially after standardization of regulatory guidelines around the world. But the direct engagement of patients with the actual trial has not been dealt with as much as the other aspects of clinical trials/studies. This is due to the fact that in clinical research, research tends to be more focused on being carried out on patients rather than with patients. This approach has made the change to a patient-centered approach slow in clinical research. The traditionally “introvert” nature of the clinical research field in accepting new technologies or ideas is also a major limiting factor in making the change to improve patient participation and thereby experience in clinical trials.

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With the development and expansion of the clinical research sector, problems related to it have also emerged. Dependency on traditional trial methods of on-site monitoring and 100% source data verification are no longer considered convenient and cost effective option. Hence, the US Food and Drug Administration (FDA) has suggested an alternative method known as Risk-based Monitoring.

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Software development has evolved via structured model creation. As we progress further in the 21st-century digital world, applications that require software models to be created are also requiring those models created to be adaptive, iterative and sufficient documentation of the coding involved. A new approach to software development termed as the agile software development began at the start of the 21st century. It along with similar programs emerged to address the dynamic nature of work in various sectors like e-commerce, health, retail, finance, insurance, etc that traditional models of software were finding difficult to provide solutions.

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One of the most important aspects of clinical research is ensuring the safety of new drugs, treatments, etc on patients. This is called pharmacovigilance or drug safety compliance. This safety aspect is monitored, implemented, and complied with in two ways. Firstly, the sponsor of the clinical research, usually a pharmaceutical organization, conducts drug safety tests at all the stages of the clinical trials they conduct wherever it is required by law. They also implement drug safety protocols at stages of the clinical research study voluntarily too. The other way in which pharmacovigilance compliance is ensured is by the laws and guidelines given by the regulatory authorities like the Food and Drugs Administration (FDA) in the US.

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Clinical research is aimed at experimenting different types of medical drugs and treatment methods to determine their efficacy and safety in treating patients. Medical care, on the other hand, is aimed primarily at utilizing existing methods of treatment and drugs approved by the medical community as safe to be used for individual patients according to their specific requirements.

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