Showing items tagged as Clinical Trials

  • 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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  • Why Russia Is an Attractive Market for Clinical Trials

    16 August, 2016 MasterControl

    When you think of countries as candidates for clinical trials, which ones come to mind? North America, Great Britain, France?

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  • Clinical Trial Recruitment Planning: FDA and Others Provide Tips and Tools

    5 July, 2016 Mukesh Kumar, Adjunct Assistant Professor, Clinical Research and Leadership at George Washington University

    Challenges in recruiting patients are the most common reason for delays and increasing costs of clinical trials. This week (1) the Clinical Trial Transformation Initiative (CTTI), a joint program between FDA, Duke University and industry representatives, announced recommendations for creating robust recruitment plans for clinical trials taking into consideration the most common challenges and potential solutions. CTTI also released a set of four tools to help with the recruitment planning. These recommendations are based on a survey of the most common reasons trials fail to recruit adequate number of participants and suggest actionable solutions.

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  • The SCIO Concept: How to Conduct Cost-Effective Clinical Trials

    17 March, 2016 Dr. Candida Fratazzi, M.D., Founder/CEOBBCR Consulting, (Boston Biotech Clinical Research)

    The average cost of developing a new drug is notoriously high. In a study conducted through the Tufts Center for the Study of Drug Development in 2014, Dr. Henry G. Grabowski and Dr. Ronald W. Hansen concluded, “The estimated average pre-tax industry cost per new prescription drug approval (inclusive of failures and capital costs) is 2,558 billion.” The story does not end here. For the past 20 years, the cost of new drug development has risen at a rate that was 7.4% higher than inflation, and clinical trials bear responsibility for most of that increase. However, the increasing cost of biomedical research is not reflected in an increase in the success rate of clinical development. Instead, it presents a major hindrance to innovation in the biotech industry, while the public must bear the brunt of the problems, absorbing the steep rise in the prices of drugs and medical devices. In order to boost the efficiency of the biotechnology industry, remove the burden of expensive drugs, and create life science products in line with the future of healthcare, we should be asking how best to modify the development process to make it cost-effective.

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  • Big Changes for ICH GCP & EU Regulations

    31 December, 2015 Laurie Meehan, Social Media Manager, Polaris Compliance Consultants

    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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  • 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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  • Ensuring Proper Training for Clinical Research Staff in Less Time

    9 July, 2015 Sandra Maddock, President & CEO, IMARC Research

    There has never been a more exciting time to be involved in clinical research. We’re seeing more advances in life-changing medical devices and pharmaceuticals than at any other time in history, creating a growing demand for qualified clinical research associates.

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  • From Open Payments to OpenFDA, the Push for Global Transparency is Accelerating

    7 July, 2015 Lisa Weeks, Marketing Communications Specialist, MasterControl

    Transparency has been a hot topic in life science circles in recent years. So hot, in fact, that it has almost become a buzzword, which implies that it lacks real substance or staying power. Transparency advocates, who are pushing to make health industry data—everything from clinical trial results to procedure pricing information—more accessible, would disagree.

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