A Recent History of Antibiotics and Where We May Be Going

| March 1, 2018

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About Clinical Research Management, Inc. Clinical Research Management (ClinicalRM) is not only involved in the testing of new antibiotics in Phase I, II, III studies, monitoring protocol development, site selection, and assistance with FDA approvals, but is also involved in responding to the challenges of antimicrobial resistance. Our epidemiologists track resistance patterns around the globe and they evaluate how the observed resistance appears, where it emanates from, and how we can best contain the spread of the new resistance factors.

Spotlight

Glenmark

Glenmark Pharmaceuticals Ltd. (GPL) is a research-driven, global, integrated pharmaceutical company headquartered at Mumbai, India. Glenmark is the leader in the discovery of new molecules both NCEs (new chemical entity) and NBEs (new biological entity). The company has a significant presence in branded generics markets across emerging economies including India. It also has a fast growing and robust US generics business. Its stock is listed on India’s two large stock exchanges, the• Bombay Stock Exchange (BSE) and the National Stock Exchange (NSE). Glenmark employs nearly 6000 people across its global operations across 80 countries.

OTHER ARTICLES

Roche Prepares to Launch COVID-19 Antibody Test System

Article | April 17, 2020

Swiss pharma giant Roche is joining the race to develop a test for COVID-19 antibodies in people who have been exposed to the disease. This morning, Roche announced the development and upcoming launch of its Elecsys Anti-SARS-CoV-2 serology test to detect antibodies in people who have been exposed to the SARS-CoV-2, the virus that causes COVID-19. Roche is eying May for the launch of the test in Europe and is in talks with the U.S Food and Drug Administration for emergency approval of the system. Antibody testing is central to help identify people who have been infected by the virus, especially those who may have been infected but did not display symptoms, the company said. Roche noted that as more information becomes available about immunity levels to COVID-19, society can return to a sense of normal much more quickly. Roche’s test will join a number of other antibody tests that have recently come on the market. Earlier this month the U.S. Food and Drug Administration approved the first blood test for COVID-19 antibodies.

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How AI and Big Data Will Disrupt Pharma’s Regulatory Compliance Standards

Article | March 4, 2020

The industry as we know it is changing. Pharmaceutical and life sciences companies across the globe are experiencing more pressure than ever to keep up with increased regulatory standards while moving at a pace that requires them to innovate in order to remain competitive. With more real-time automation and the steady increase in AI and Big Data sweeping the landscape, what used to be a slow-to-change and risk-averse industry is now expected to see a significant shift towards newer technology that focus on heightened regulatory standards. Here’s how your company can get ahead of what industry experts are calling, Pharma

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Clinical Development Risks and Issues in a COVID-19 World

Article | March 20, 2020

Global clinical guidelines have shifted the industry toward risk-based approaches for the planning and execution of clinical trials. The ICH’s guidelines for Good Clinical Practice state that sponsors should evaluate identified risks against existing risk controls by considering “the likelihood of errors occurring, the extent to which such errors would be detectable, and the impact of such errors on human subject protection and reliability of trial results” (ICH E6 R2).

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WANT LESS “LIABILITY” AND MORE “RELIABILITY” FROM YOUR CLINICAL MOBILITY SOLUTION?

Article | March 2, 2020

I recently discussed the different ways that consumer-grade smartphones can compromise patients’ health, safety and overall care. However, some clinicians and healthcare administrators have indicated in recent months that they need help selecting the right enterprise-grade mobility solutions for their unique operating models and workflows. There are many different hardware and software options, and a single rugged device can come in multiple configurations. So, how do you know if you’re picking the right communication tools for your clinicians? The key is to first set performance expectations for the total mobility solution rather than the device alone.

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Spotlight

Glenmark

Glenmark Pharmaceuticals Ltd. (GPL) is a research-driven, global, integrated pharmaceutical company headquartered at Mumbai, India. Glenmark is the leader in the discovery of new molecules both NCEs (new chemical entity) and NBEs (new biological entity). The company has a significant presence in branded generics markets across emerging economies including India. It also has a fast growing and robust US generics business. Its stock is listed on India’s two large stock exchanges, the• Bombay Stock Exchange (BSE) and the National Stock Exchange (NSE). Glenmark employs nearly 6000 people across its global operations across 80 countries.

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