Category: Clinical Research

Fresh off a $500 million first financing round in late May this year, Outcome Health has already set out to improve its health intelligence offerings with the help of a new collaborator: Harvard Health Publications, Angus LLu, Associate Editor, writes on Fiercebiotech.com.

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Multi-tenant cloud solution acts as a front end to any safety database and integrates with mobile-based applications to automate and standardize the case intake process for reports received from the field, reducing costs for greater ROI, says an ArisGlobal statement.

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According to a last year’s research on checking the pulse of the pharmaceutical industry’s use of trial master file (TMF) and collating feedback from 217 TMF managers from across the globe shows humongous change is under way as the industry shifts from passive to active TMF management and adopts advanced electronic TMF (eTMF) applications to improve inspection readiness and shorten clinical trial times, Rik van Mol, Vice President of R&D Strategy, Europe, at Veeva Systems, responsible for the Veeva Vault R&D suite of applications writes on pharmexec.com.

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Individuals have an inherent right to access their own health information. Patient data access can be a critical tool for proper care, but both providers and patients often face confusion about how HIPAA regulations impact the exchange and release of protected health information (PHI).

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In the Clinical Research arena, the Environmental Monitoring (EM) Program – comprising of viable and non-viable monitoring elements – is designed to routinely monitor particulates as well as micro-organisms in key spears of pharmaceutical manufacturing facility, especially in the aseptic processing areas. While the viable or micro-biological monitoring is replete with routine monitoring of the manufacturing environment for the trace of micro-organisms, the non-viable particulate monitoring, calculates the airborne particle count and further offers inputs on the routine maintenance of the clean room air classification.

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The global e-commerce Major Amazon has made many awestruck with its foray into the hitherto untapped area of healthcare. Although, the company has a perfect platform for selling any product under the sun, including pharmaceutical items, but then why should it get into healthcare segment is the question that begs an answer, according to medium.com report.

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A new research report, published in the Journal of Medical Internet Research reveals that the mobile device (Mobile Technology) can effectively support a slew of things within the clinical research such as project management, data management, and telemonitoring, according to a mhealthintelligence.com report.

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Clinical trials and research completely depend on the consent of people who volunteer to participate in such studies. These people are termed as human subjects. Health and Human Services plays a significant role in protecting and safeguarding  the interests and well-being of these subjects. It deals with rules for Drug Safety, Pharmacovigilance and more.

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In the present times, when personalized medicine is the dominant trend patient centricity in clinical trials, research continues to grow at a rapid rate. Today, the patient wants; requirements and complete well-being have become the priority in clinical research and trials.   Patient -centricity in clinical trials may require substantial investment in the clinical trial design but has a positive impact on recruitment and retention of participants in the trials and studies.       

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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 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 participants.

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On a run to adopt new technologies and implement effective ways which could bring out possible changes in the healthcare industry a lot of innovative techniques have been introduced into the market.

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As many healthcare providers have started adapting to electronic health records (EHR) the healthcare sectors around the globe are in a constant search to find new activities that are related to the field. The survey suggests an increasing demand for health information technology initiatives. Facilities that serve the need to grow innovations, efficient execution of studies, patient access enlargement and patient centricity enhancement leverage biopharmaceutical enterprises with its changing infrastructure. It is expected a potential health information technology in clinical trials could change its landscape to a different level.

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Over the past few years, an increasing protocol complexity has garnered a lot of attention among clinical trial experts. It has lead to various important studies beginning from meditating insights metrics warehouse which reveal that clinical studies have reached to a significant level of complexity in the recent times. In spite of a larger increase in metrics in the first half of the past decade and continued warnings from experts, the complexity continues to be on an upward surge through admittedly less steep and trends. A quantifiable or reputable measure of effort is necessary to conduct a study on the protocol complexity value which was supposedly a new addition to Medidata Insights metrics warehouse. There is a factor called Relative Value Unit (RVU) and it will be multiplied by the quantity of each trial procedure and clinical research activity conducted per completed patient. The result of this calculation will be used for the association of burden on sited and to conduct relevant studies.

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In fact, it is really a challenging task to identify disruptive thinkers in clinical trials for the stakes are very high in the present trend. There are some of the dedicated forums conducted around the US in a delightful manner to instil potential thoughts out of people with an in-depth understanding of existing scenario in clinical trials. Such forums will be conducted as an annual event which can be relied upon by life science industry for the latest thinking in clinical trials for 21st-century drug development.

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Data-Management Plan (DMP) is a formal document describing how you plan to handle research project data during the research and after the research is completed. It describes what tools & techniques you will use to collect, store, manage and analyze this data. Mechanism to preserve research data and means to share it with others also form a part of DMP. Most agencies, which fund the research projects, require a DMP with every funding request.

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