Showing items tagged as clinical research organization (CRO)

  • 2018’s Top Clinical Pharma/Bio Trends to Date

    20 June, 2018 by James Jardine, Staff Writer, MasterControl

    Economic, technological, policy and scientific changes occur so frequently in the hypercompetitive pharmaceutical and biologics sectors that only the most versatile and far-sighted companies can thrive. Get the inside scoop on the top five clinical trends experts believe will be the difference between success or failure for pharma/bio organizations.

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  • A Force for Change: Millennials

    29 March, 2018 by Craig Morgan, Head of Marketing, goBalto

    A look at how the changing makeup of the clinical research workforce, with particular attention to the millenial generation, may present future adjustments and opportunities.

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  • 5 Guidelines for Writing a Useful Clinical Monitoring Report

    15 November, 2017 by Brandy Chittester, IMARC Research, Inc.

    A well-written monitoring report is an essential part of documenting clinical trial oversight. In addition to being required by ISO and ICH guidelines, it also tells the story of the clinical trial to the FDA, demonstrating site performance and sponsor oversight during an FDA inspection. Here are a few important guidelines you and your staff should follow to ensure your clinical monitoring reports are accurate and complete.

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  • eTMF Management: Don’t Settle for a One-Trick Pony!

    12 November, 2015 Patricia Santos-Serrao, MasterControl's Market Segment Manager, Global Pharmaceutical, Blood & Biologics

    Organizations searching for an electronic trial master file (eTMF) solution are likely to stumble upon various vendors claiming to be the “industry leader in eTMF” or some variation of this statement. With so many vendors claiming to be leaders, what does that mean to be a leader in eTMF? Should it factor into my decision as I evaluate and choose a solution for my organization? The answers to that question may not be a clear cut as one may think.

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  • Holistic CQMS: The Modern Model of Clinical Trial Management

    23 November, 2015 James Jardine, Marketing Communications, MasterControl Inc.

    The life science industry is experiencing a transformation in the clinical trial management paradigm. The timeworn clinical trial management system (CTMS) archetype is being increasingly supplanted by a more comprehensive and efficient clinical quality management system (CQMS) model.

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  • CLIA vs QSR (What You Don’t Know Can Hurt You)

    4 February, 2016 Paula Gray, Navigant & Sharon Kvistad, Navigant

    Many industries including automotive manufacturers, NASA, information technology systems, and countless others suggest or even require implementation of a Quality Management System (QMS) in order to ensure products are manufactured to a high quality standard. For products like medical devices, QM systems ensure that products are not only of a high quality, or deemed “effective” to perform as they are intended, but are also safe for their intended use. For all laboratory testing, Congress passed the Clinical Laboratory Improvement Amendments (CLIA), in 1988, which established quality standards to ensure the accuracy, reliability, and timeliness of patient test results regardless of where the test was performed. The Centers for Disease Control and Prevention (CDC) and the Centers for Medicare & Medicaid Services (CMS) published final CLIA Quality Systems laboratory regulations that became effective April 24, 2003.

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  • 10 Tips for Enabling Better CRO-Sponsor Collaborations

    19 October, 2016 Craig Morgan, Head of Marketing goBalto, Inc.

    By 2020 72% of clinical trials are anticipated to be outsourced, up from just 23% in 2012. Sponsors are seeking cost reductions, access to specialized knowledge, and increased speed and agility. Meanwhile, CROs focus is on business goals related to economic outcomes for their owners, investors and shareholders. Each group is expecting deliverables and timelines to be met or exceeded for potentially different business reasons, leading to a traditional client/vendor-type relationship. Though alliances and partnerships are increasing, there continues to be a client/vendor mentality at the operational and management levels, which perpetuates a lack of trust and empowerment.

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  • Optimizing Outsourcing Options for Small Sponsors

    10 November, 2016 Laurie Meehan, Social Media Manager Polaris Compliance Consultants, Inc.

    What can small sponsors do to secure the outsourcing resources they need as large CROs form strategic alliances with Big Pharma?

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  • The Data Driven Reality of Clinical Trials

    7 March, 2017 by Craig Morgan, Head of Marketing, goBalto

    Why are metrics important in starting clinical trials? This question may seem counter intuitive, as we are exposed almost daily to the dire performance of clinical trials and their spiraling costs resulting from incurred delays.

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  • Site Selection: Don’t Forget About the Study Drug

    13 April, 2017 by Laurie Meehan, Social Media Manager, Polaris Compliance Consultants, Inc.

    As a sponsor or CRO, you understand the importance of a thorough site selection process. A site needs to be able to meet enrollment targets and timeframes, protect the rights and safety of study participants, execute the protocol, deliver quality data, and maintain GCP compliance. That’s what your site feasibility surveys and pre-study visits are designed to evaluate. And as you’re assessing a site’s abilities, the site is conducting its own feasibility process. They’re mining their patient data

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