Category: Clinical Research

  • DoE Approach to Clinical Trials

    The Design of Experiment or DoE for short refers to that branch of applied statistics which deals with planning, conducting, analyzing and interpreting results of controlled tests with the objective of assessing the outcome in response to variables due to changes in one or more factors. The original work in this field was done by R. A. Fisher in the early 20th century. He argued that a properly designed experiment and execution leads to avoiding frequently encountered problems in analysis it later.

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  • Clinical Research Associate – An overview

    The Pharmaceutical industry is responsible for bringing in new drugs for the treatment of diseases. For this, it largely depends on clinical studies and trials conducted by clinical research teams that include research associates and other professionals.

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  • Drug Biotransformation In Clinical Trial Management

    The process of drug biotransformation has been carried out by complex enterprise formed on the basis of considering various elements including a plethora of research activities such as fundamental clinical research experience clubbed with a number of disciplines, processes, and technologies. It also takes diverse inputs referring to drug knowledge, disease knowledge, professional or personal affairs, regulatory/legal issues, marketing and business practices and medical factors in addition to global business. Health care issues play a predominant role in determining health care costs which are then utilized for the process of drug development. In fact, of late it has been determined that factors impacting healthcare utilization thrust a great force to refine the fluctuation in potential drug biotransformation in clinical trial management.

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  • Mobile Apps for Clinical Trial!

    In recent years, mobile apps have revolutionized communication and outreach in every sphere of life. It has given ease, flexibility to sharing information and messaging.

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  • Importance Of Clinical Nurse In The US!

    The health care system in the United States has been an extensive area which has scope for several designations and one of the important and essential job profiles is the role of clinical nurse specialists. They take care of numerous responsibilities and have the potential to serve the needs and expectations of health care consumers. The demands of such consumers are met by Clinical Nurse Specialist (CNS) and Advance Practice Registered Nurse (ARPN). However, there are exclusive responsibilities and privileges assigned to ARPN but not for CNS. Some of those distinguished features remain as a challenge for the number of clinical nurse specialist and they are invariably working to look upon it and prove themselves in the US health care industry.

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  • mHealth-New Initiatives

    The involvement of wireless technologies has played a huge role towards the development and achievement of numerous health objectives especially in mHealth technology across the globe.  Some of the powerful combination of factors is responsible for this technological change which includes the advancement in mobile technologies, applications and the rise in new opportunities for the integration of mobile health into existing eHealth services. Over the years, the continuous growth in the coverage of mobile cellular networks has been of great support for the flourishing mHealth initiatives. Undoubtedly, mHealth has acquired a prominent power in health care industry provided with the substantiate increase in wireless subscribers. It has been reported according to the international telecommunication union (ITU), now there are over 5 billion wireless subscribers out of which over 70 percent of the subscribers reside in low and middle-income countries. An additional alibi to the establishment of strong wireless networks is given by GSM association which reports 85 percent majority of wireless signals cover 85 percent of the world population. Obviously, the reports suggest a possible extension in the reach of the electrical grid more than it was anticipated.

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  • Patient Management and Retention – Issues in Clinical Trials

    Over the past few years, the issues related to patient management and retention, pop out to instill discussions among various professionals involved in clinical trials. Most of the times, such discussions lead to identifying the difference between patient retention and patient adherence; revolving around patient management. However, the studies have shown a significant difference between the two in spite of confusions arising out of co-relation. The basic understanding quotes that patient compliance and retention is the two basic factors responsible for the success of clinical trials.

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  • Critical Importance of Comparator Temperature Excursion for a Clinical Trial!

    Pharmaceutical companies and manufacturers have the responsibility of delivering quality medicinal products with correct attributes to patients. All medical products are affected by temperature variations and may lose potency or even cause harm.

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  • Image Analysis In Clinical Trials

    In order to discover and define the most basic primary and secondary endpoints in clinical trials, the process of imaging is extremely useful. When classifying the applications of imaging for study outcome purposes, the performance of imaging equipment and software tools have played an important role with respect to its tremendous technological improvement. Over the period, the idea of image processing has evolved significantly from the use of standard X-ray angiography on 35 cine-film/plain film to digital cath lab systems with DIOCAM compatible standards linked to digital storage.

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  • Clinical Trial Management System Checklist

    Clinical trials play a significant role in health-care.  Clinical trial is an important feature of clinical research conducted by healthcare and pharmaceutical industries. The success of these trials depends of many logs, trackers, protocols, templates, essential documents and more. The studies need to be meticulously monitored, carried out with care and precision and reached to an accurate conclusion.

    In today’s world of ever changing dynamic and challenging life conditions clinical trials have become very complex. These trials require a sophisticated and integrated approach that assists in calculating trial costs, regulatory risks and adhering to strict schedules.

    CTMS or clinical trial management system is specialized software used by healthcare industry, especially in biotechnology and pharmaceutical fields for clinical trials for clinical research. CTMS defines and manages all activities that are included in the long and rigorous trial process.

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  • Job Opportunities for A SAS Clinical Associate!

    A SAS Clinical Associate is an individual who is competent at using SAS programming skills for clinical work. Recent studies show that SAS analytics skills for clinical research are the most valuable skills to cultivate. Career opportunities are plenty as demand for SAS talent has an increasing trend with more than 80,000 customer sites around the world.

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  • A Synopsis Of Compass Intelligent Monitoring!

    Having been exposed to a lot of risk-based monitoring strategy, sponsors and CROs around the globe, it’s a great delight to improve monitoring strategies after the arrival of compass intelligent monitoring. People with diverse requirements towards clinical trial monitoring in the trade industry have started to associate with each other to understand the concepts and techniques available in the emerging system of monitoring strategies. The root of compass intelligent monitoring rises from the optimization of clinical trials with the support of highly advanced technology and analytics. It is very important to realize that the advancement has taken a great leap on various clinical trials and monitoring outsourcing models.

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  • Interactive Response Technology in Clinical Research

    Interactive Response Technologies (IRT) perform many functions in patient interaction and drug supply chain management during clinical trials or research. They are in use for more than 15 years as a means of increasing efficiency in clinical trials. However, extensive use of these technologies has happened in the last 7-8 years.

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  • Electronic Document Management Systems (eDMS) – An Overview

    Electronic Document Management system or eDMS is a computer-based program designed for creation, storage, retrieval and control of documents.  eDMS are workflow based systems where a workflow is defined for each document from its creation to archival. This system helps in easy retrieval and exchange of information between various entities such as clinics, doctors, clinical researchers, etc. The information can be in the form of documents, reports, images, audio/ video files.

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  • End to End Patient Engagement Clinical Research!

    Experts feel that the main setback; to the End to End Patient Engagement programs in Clinical Research is the problems of awareness, understanding, and trust among trial participants and the providers. Together with this, is the disconnect between the interest shown by the patient to participate and whether he actually enrolls for the program. Other hurdles include collecting a particular group of patients for a particular type of study and the fact that about 10 % of those that do enroll are lost to follow-up. “In order to solve this problem the specialty service provider ‘Bioclinica’ has suggested that two separate divisions be created by the company under its ‘Global Clinical Research business segments’ The president and CEO of ‘Bioclinical’ John Hubbard feels that together both the divisions will succeed in creating an integrated offering which will convince patients to enroll in this end to end patient engagement in clinical research.

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