Category: Clinical Research

A career in clinical research can begin at any of the different stages of clinical research. An aspirant in the clinical research field usually begins as a clinical research associate or as a clinical research scientist or as a clinical research coordinator. There are other entry positions, but these three are the most common entry route to a career in clinical research.

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Medical writing is a scientific discipline where documents related to medical related works are written by professionals who have a background in life sciences and have skill in writing. Medical writing primarily focuses on providing content for the pharmaceutical industry. It involves writing about different document types like regulatory or research related, disease or drug-related promotional material in print and web form, content for health-related websites, magazines, etc and also for journalism and marketing purposes that relate to the medical sector.

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The Case Report Form (CRF) is a tool used in clinical research in the form of paper or an electronic questionnaire by clinical research sponsors to gather and record information about patients participating in the research. The main objective of CRFs is to preserve and maintain the integrity and quality of data collected. CRFs are important to every clinical research project because they contain all the data about every single participating patient.

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Clinical trials involve the production of large quantities of information that need to be recorded in order to analyze them for adverse events, patient profile, etc. Electronic record keeping has changed the manner in which information about trials and patients are stored and accessed. Electronic records also serve as a means for researchers to access information about previous trials in order to find if there is any data that had been overlooked but might be of use. The term data and information used here are interchangeable and include numeric data files, qualitative files like interview transcripts, field notes, and research files in audio and video formats among others.

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Clinical trials in the 21st century are conducted with the involvement of multiple stakeholders like clinical investigators, patients, hospital staff, physicians, regulators, and research sponsors that include government, academia, industry, non-profit organization among others. Each of these stakeholders bring different resources into the trial and varies from monetary resources to research knowledge.

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Clinical research is a science involved in testing new drugs that are discovered to have the potential for treating various medical treatments to patients and healthy volunteers. Clinical research cannot be simplified and defined as a single job needing two to three skills. Clinical research is a long process actually involving multiple steps and operations, all requiring different skills along with interdisciplinary skills.

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A clinical trial, which is the investigation of a new drug for its medical potential, consists of four phases. Although the number of steps may vary according to the context of the clinical trial being conducted, it is generally observed that four phases are involved in the entire investigation starting from safety assessment of the sales and marketing phase. The aims of these four phases can be broadly described in the following manner:

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Foreign or International medical graduates (IMGs) in large number try to opt for pursuing a career in medicine in the US. But it is not always possible for all of them to do so. In the case of non-availability of the core medical option, there are other options available.

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Artificial intelligence is deemed to be an integral part of the fourth industrial revolution. This revolution, unlike previous industrial revolutions, is expected to bring in a system revolution rather than a product revolution as told by the founder of the World Economic Forum, Klaus Schwas. By a system revolution, what is inferred is that the future holds opportunities for melding cyber and physical systems via artificial intelligence-real world interfaces. An example of this is IBM’s Watson which is an artificial intelligence, cognitive computing program that is currently being tested by Mayo Clinic researchers, in collaboration with IBM on the difficult task of recruiting matching patients with the requirements of a clinical trial.

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The best practices for clinical trial operations are difficult to define/describe due to clinical trials being diverse in nature. Yet there are certain requisites that are universally relevant to all clinical trials and best practices can be adopted within these requisites for a clinical trial. The following is a list of such requisites.

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Clinical trials refer to and involve testing new drugs for diseases and other negative health conditions that affect human beings and discovering information about the new drug’s efficacy on such health conditions.

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Clinical trials are how researchers and chemists working with drug companies check out the effectiveness of new drugs before they are made available to the general public. There are many people who apply for clinical trials and the reasons are varied, making some quick money being one of the most common of them.

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Clinical trials are conducted for collecting data related to safety as well as the efficacy of new drug along with device development. There are various steps as well as stages of approval in such a trial. A drug or a device cannot be released in the market without passing these essential phases.

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With risk based monitoring gaining importance in the clinical trials and with the release of the FDAs directives, it has become imperative to implement RBM strategies in each stage of drug development.

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Every year, millions of dollars are invested by pharmaceutical research and development companies due to clinical trial failures. All the capital invested on research development and experimental procedures is totally lost, when these clinical research trials fail for various reasons.

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