Best Practices in Clinical Informatics and Healthcare

Clinical informatics involves the discipline of using Information Technology for clinical practices. The infusion of IT into clinical practices is a very major step in the healthcare industry today. Clinical informatics helps to hasten and accelerate the speed at which information about clinical trials is sent out to different locations across the world. It facilitates greater and speedier exchange of clinical information, fostering greater collaboration between clinical researchers situated in different parts of the globe.

The trail of an FDA clinical trial audit

An FDA clinical trial audit need not be feared, so long as there is compliance with regulatory requirements. more...


Clinical Risk Management Lies at the Heart of Patient Safety

Clinical Risk Management is the process of identifying and mitigating risks in a healthcare setting. Risks are inherent in a clinical or healthcare practice, as they are in any other activity. But the field of healthcare has to be doubly wary of risk management because an adverse risk can cause irreparable loss if it leads to an event such as death. To a healthcare organization or practice, a bad event can harm the name beyond repair. more...


Implementation of Regulatory Aspects of Clinical Research is critical

One of the prime areas of clinical studies is regulatory aspects of clinical research. This applies in almost equal measure to medical research as a whole. The FDA and other regulatory bodies have spelt out a number of regulations that have to be complied with if the clinical research is to be approved. These regulatory requirements cover all aspects of clinical research. A look at some of these regulatory aspects would be instructive: more...


Understanding Clinical Governance

Clinical Governance has come to be a discipline of healthcare. It may be said to have originated in the UK in the mid-1990's following the outbreak of the Bristol heart scandal, at which it was discovered that lackadaisical approach on the part of the medical team that performed pediatric cardiac surgery resulted in too many avoidable deaths of young patients. more...


A peek at Clinical Laboratory Science

Clinical Laboratory Science, alternatively called medical technology, is the science that provides laboratory-related information and feedback to medical professionals. These inputs help health practitioners diagnose the laboratory aspects of a disease. In simple terms, Clinical Laboratory Science provides the medical practitioner the laboratory information needed for arriving at a precise laboratory finding of an ailment. more...


The nature and purpose of Clinical Practice Guidelines

Clinical Practice Guidelines (CPGs) refer to a set of guidelines that medical practitioners and other caregivers employed in healthcare can use as reference to help in the decision-making process for ensuring better health outcomes for patients. These guidelines, since they relate to clinical practice, are arrived at after a meticulous, deep and systematic assessment of clinical evidence, which is at the core of evidence-based care. more...


Clinical Research Informatics - its prospects and challenges

Among the subdomains of biomedical informatics, Clinical Research Informatics (CRI) has been evolving of late into a full-fledged discipline in itself. It is basically concerned with developing an assortment of tools and methodologies that help coalesce and give a sense of interconnectedness to the various sub disciplines of biomedical informatics. It seeks to coordinate and connect disciplines such as community practice, healthcare settings, clinical trials and basic research to gather and analyze informatics from these more...


Clinical Trial Recruitment Methods

Clinical trial recruitment methods are the basis for selection of the appropriate subjects for a clinical trial. Proper selection is the fundament of clinical research. This factor is the biggest contributor to the outcome of the research, since it is on the subjects - the participants in a clinical research - that the whole purpose of the research depends. We may liken the selection of subjects to the raw material used for production. Just as the quality of the raw material determines the quality of the final output; the subjects that go into a clinical trial decide the veracity and quality of the clinical trial. more...


Rationale for Clinical Trial Regulations

Clinical trials, as we all know, are carried out to test the efficacy of a new drug or device being developed for a specific condition or disease. Clinical trials are experiments that have a high degree of risk if they are not properly implemented. For this reason, it is necessary for regulatory bodies to regulate clinical trials. more...


Standard Operating Procedures for Clinical Trials

A set of standard operating procedures for clinical trials is absolutely vital for ensuring the effectiveness of the study for a number of reasons. Standard operating procedures for clinical trials are a very potent means to help researchers, principals or sponsors ensure the accuracy and consistency of the procedures needed for the clinical trial. more...