Showing items tagged as Clinical Trials

  • 2020-bl-coda-corp-vaccines_132x132

    The Fundamentals of Immunization, Part 1

    The race to develop a safe and effective vaccine against COVID-19 is on, and it has everyone talking. Inoculation,vaccination and immunization are terms that are often used interchangeably, but have very different meanings.

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  • 2020-bl-thumb-well-controlled-clinical-trials

    How to Conduct a Well-Controlled Clinical Trial

    Successful clinical trials are a critical stage in the product life cycle of any life sciences product. Brandy Chittester, president of IMARC Research, outlines how manufacturers can conduct well-controlled trials that meet regulatory compliance and delineates pharmaceutical trials from those of the medical device industry.

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  • 2019-bl-thumb-socra-conference-associations

    3 Clinical Trends Shaping the Medical Device Space in 2019

    The medical device industry is changing at a pace that most in the industry are struggling to keep up with. And nowhere is that more evident than in medtech’s clinical research and trials space. Glean some of the hottest new clinical trends as we move into Q3 and Q4 of 2019.

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  • 2019-bl-thumb-3d-printing-of-pharmaceuticals

    3D Printing of Pharma Dosage Forms a Promising New Tech for Discovery

    Pharmaceutical manufacturers depend on innovation and new technologies to find new cost-effective ways of speeding up the drug development process. 3D printing (3DP) allows greater flexibility during the discovery process through rapid prototyping formulations and the potential for on-demand production of clinical samples. Learn how 3DP may change the way pharma does business.

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  • 2018-bl-thumb-top-5-nutraceutical-trends-in-2-2018

    Top 5 Nutraceutical Trends in 2018 - Conducting Clinical Trials on Nutraceuticals

    Nutraceutical companies have never been required to conduct clinical trials. However, many are now voluntarily taking on this endeavor to show that their products work as advertised. This adds legitimacy to nutraceuticals and provides a better value for consumers, but the complexity of clinical trials presents a significant hurdle.

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  • MasterControl Logo

    The Evolution of Medical Device Clinical Trials, Part 2

    Regulatory shifts and global advancements are reshaping the way medical device companies approach their clinical trials. Learn about the present state of medical device regulatory compliance and envision the future of the clinical landscape for devices.

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  • MasterControl Logo

    The Evolution of Medical Device Clinical Trials, Part 1

    Medical devices face a unique set of challenges during the course of clinical trials. Get an insightful look into the regulatory standards that affect medical device clinical trials and learn how clinical trials for devices are significantly different from – and often more flexible than – those of drug products.

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  • 2018-bl-thumb-clinical-trends-med-device

    Noteworthy Clinical Trends in Med Device to Watch in 2018

    Radical, whirlwind change is a core feature of the medical device industry. A clinical/regulatory expert provides insight into the clinical developments currently shaking up the device world and explains how device companies can adapt and thrive in a burgeoning industry that seems to reinvent itself daily.

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  • 2018-bl-thumb-mc-top-clinical-pharma-bio-trends-to-date

    2018’s Top Clinical Pharma/Bio Trends to Date

    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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  • MasterControl Logo

    Top 5 Pharmaceutical Trends to Keep on the Radar in 2018

    Get up to speed on key takeaways from what are expected to be some of the most tranformational trends to affect the pharmaceutical industry in 2018. And for further analysis of some of the top trends in pharmaceuticals this year, check out the associated white paper.

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  • 2018-bl-thumb-force-for-change

    A Force for Change: Millennials

    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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  • 2018-bl-thumb-comedy-can-teach-about-communication-clinical-trials

    What Improv Comedy Can Teach Us About Communication in Clinical Trials

    A look at how some of the insights behind improv comedy training can help clinical trial teams develop and improve communication and problem-solving skills. It's no laughing matter.

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  • 2018-bl-thumb-3-valuable-takeaways-tmf

    3 Valuable Takeaways from the 2018 TMF U.S. Summit

    Clinical professionals from around the U.S. gathered Jan. 16-18 at the TMF U.S. Summit 2018 in Orlando, Fla., to discuss current clinical study trends and some of the pressing issues relating to trial master file (TMF) management. Three underlying themes were prevalent throughout the 7th annual event.

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  • 2017-bl-thumb-5-guidelines-for-writing-a-useful-clinical-monitoring-report

    5 Guidelines for Writing a Useful Clinical Monitoring Report

    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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  • Why It’s Time to Revisit FDA’s Quality by Design

    Patients of Alzheimer’s disease, their families, and health care advocates recently encountered back-to-back disappointments when two clinical trials for Alzheimer’s drugs failed in quick succession. First, Eli Lilly & Co. stopped its late-stage clinical trial for solanezumab, then Merck & Co. ended its clinical trial for verubecestat. Both studies failed to show efficacy.

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  • 10 Criteria to Aid in the Selection of Investigative Sites

    Investigative sites are the heart and soul of clinical trials, essential to ensuring the efficacy and safety of pharmaceutical compounds in humans. Site selection is pivotal to the successful execution of trials, which are not only long and bureaucratic, but are also experiencing diminishing returns. Studies estimate that it costs upwards of $2B dollars to bring a new drug to market, with daily revenue losses in ranging from $1M to $8M due to delayed market entry.

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  • The Data Driven Reality of Clinical Trials

    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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  • Big Changes for ICH GCP & EU Regulations

    The most substantial change to international guidelines in 20 years occurred earlier this year when the ICH* issued a draft addendum to its GCP guidelines, ICH E6(R2).

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