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Introduction to Clinical Data Management

  A clinical trial is the means of determining whether a vaccine, drug, or operation is effective. Clinical Trials, to put it another way, are a sort of studies to investigate new tests and treatments and assesses their effect on human health outcomes. A vast amount of information is created throughout these lengthy and effectively planned clinical trials, which must be maintained. Clinical Data Management comes into action in this situation. Because there is such a strong need for professionally qualified individuals in the field of clinical research, it is critical for ambitious candidates to undergo clinical research training . CDM and Process: The process carried out by collecting, analyzing, and handling the information recorded during clinical trials is known as clinical data management. The primary goal of CDM is to gather as much data as feasible while maintaining a high level of data quality by eliminating errors and inconsistencies. Process: 1     Designing and crea
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Applications of AI in Pharmacovigilance

The significance of medicine and technology in our lives is something that the Covid 19 outbreak has taught us. In fact, the vaccinations for the same were created in the shortest time in human history. This massive undertaking was made possible by advances in medicine and information technology. The two most demanded fields, pharmacovigilance and artificial intelligence, can be combined to progress the field of medicine. AI research is defined in computer science as the concept and development of computer systems capable of doing activities that would ordinarily require human intelligence, such as visual perception, speech recognition, decision-making, and text analysis. Artificial intelligence (AI) technologies have the potential to improve medicine safety evaluations due to large amounts of electronic data. In clinical research, data analysis, which use natural language processing (NLP) technologies and text mining to extract relevant data from a variety of unstructured sources,
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Good Pharmacovigilance Practice Guidelines

  This system, like all other systems, is defined by its processes, structures, and outcomes. The quality of this system can be defined by the characterized system that produces significant parameters based on the drug safety objectives for the sole purpose of good pharmacovigilance practices  that provide guidelines on the pharmacovigilance system's processes and structures. The quality structure includes the pharmacovigilance system's organisational structure, responsibilities, processes, procedures, and resources, along with resource management. All of this necessitates the completion of pharmacovigilance and clinical research training . Good Pharmacovigilance practice guidelines include:       All criteria based on patients, healthcare professionals, and public health must be met solely on the basis of safety.          All departments associated with the pharmacovigilance department should maintain an overall highly efficient and cooperative rapport.          All memb
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Active Surveillance Method in Pharmacovigilance

 As active surveillance takes more time and money, it is employed less frequently in emergency situations. However, it is frequently more thorough than passive monitoring. It's typically used to keep track of case counts when an outbreak has started or is suspected. Community health workers may be instructed to aggressively discover cases in the community in order to identify individuals who do not seek care at medical institutions. To put it another way, it confirms a specific amount of adverse events through a continuous, pre-planned procedure. It's a way of ensuring that passive reports are representative and that health-related occurrences are reported more thoroughly. Hence, getting your clinical research training and certification can be a great investment in your professional future.  A) Sentinel Sites: 1) This entails gathering AE data on a subset of the overall population in order to gain insight into the wider population. For instance; to research about the various
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Clinical Trial Recruitment

  A clinical trial is a study conducted on an individual for research purposes with the aim of assessing surgical, medical, or behavioural interventions. Clinical trials are the primary method used by researchers to determine whether a new treatment, drug, or diet is safe and effective for humans. In the clinical trial patient recruitment process, sponsors, sites, or  recruitment companies look for ways to join with patients who may be suitable for their trial. The advantage of contacting patients online or digitally is that you can reach them from anywhere in the world. Digital platforms facilitate contact establishment and encourage active participation in clinical research. Recent trends in clinical trial recruitment include increasing use of digital advertising to find the most suitable patients for the trial.Clinical research courses and  clinical research training is continually updated based on the disease and evolving technology to ensure the complete s
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Importance of Pharmacovigilance

Pharmacovigilance is a wide term to explain drug safety. It explains the collection, safety, analysis, prevention, and monitoring of the ill-effects of drugs and therapies. It is a process-driven and methodical area within the pharmaceutical industry. This is a safety study of commercially accessible drugs that are tested under real-world conditions or in real-time clinical use in large communities. Pharmacovigilance aims to identify unknown safety problems as early as possible. It also aims to detect an increase in the frequency of these misbehavior's , to quantify the risks, and to avoid the patients from being affected unnecessarily.  Pharmacovigilance encourages education and clinical training by providing clinical research courses, pharmacovigilance courses, clinical research training etc.  Drug professionals' knowledge and awareness of a drug's safety profile plays a fundamental role in patient well-being. These professionals should be well aware of
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Medical Writing

Medical writing includes the design and production of printed or digital documents, particularly about medicine or health care. It is also, an art of creating clear and precise scientific documents that includes clinical research documents, healthcare websites , fitness and medical journals as well as health-related news. Along with this, it includes documentation for clients of media industry, government, clinical research organizations (CROs) and medical device manufacturers. You can be a professional medical writer with clinical research courses and training.  Medical writing can be broadly classified into Regulatory medical writing and Educational medical writing: 1)       Regulatory Medical Writing : Regulatory writing is a branch of medical writing that focuses on the documents that a medical writer or a regulated medical writer must submit to the regulatory authorities at various stages of a clinical trial. In general, each country has its own national auth
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