Industry Insights

61. A Framework For Measuring Training ROI Using Quality Metrics 12/13/2017

    This article proposes an approach using data-driven insights from standard quality culture and performance metrics, with CoPQ calculations, to measure training return on investment (ROI). 

62. A cGDP Primer: New Distribution Models For Life Science Supply Chains 9/2/2016

    The life sciences industry has undergone many changes over the last decade, with consolidation, mergers, and acquisitions across both small and large pharmaceutical and biotech companies. One result of these changes is complex supply chain models, with a combination of in-house and outsourced research, product development, and commercial operations. The level of complexity has presented challenges for stakeholders and their supply chain partners: suppliers of materials, components, and packaging, as well as contract research (CRO), contract manufacturing (CMO), and logistics service providers.

63. How Will The CVS/Aetna Merger Impact Biosimilars? 1/23/2018

    The desired merger of CVS and Aetna introduces a dramatically different dynamic into the healthcare landscape — the vertical integration of two different types of businesses, a pharmacy/drug distribution entity and an insurance company. How will such a new entity impact biosimilar use?

64. Pulling The Trigger On Risk-Based Monitoring 4/17/2014

    Site monitoring is an essential element of clinical trials, ensuring quality and integrity of a clinical investigation. Monitoring uncovers potential problems such as data entry errors or missing data, assures that study documentation exists, assesses the familiarity of the site’s staff with the protocol and required procedures, and provides a sense of the overall quality of a site. By Rick Morrison, CEO, Comprehend Systems

65. How GSK Launched A Continuous Manufacturing Pilot Plant — And What It Learned 7/10/2017

    This article focuses on GSK’s continuous manufacturing initiatives, the hurdles it faced in bringing the pilot plant online, the lessons it learned from the experience, and what it plans to do next with the technology.

66. Should You Rotate Disinfectants? Industry Experts Weigh In 9/14/2018

    Whether to rotate disinfectants has been debated in the pharmaceutical industry for years. This article discusses the concept of disinfectant rotation and the current mainstream industry practices.

67. Identifying Outliers In Process Data Using Visual And Analytical Techniques 1/12/2018

    Properly identifying outliers can assist companies with the proper establishment of trending and excursion limits for complaint and nonconformance management and other aspects, which can trigger investigations or initiate the formal CAPA process.

68. Navigating The Regulatory Landscape For Therapeutic Radiopharmaceuticals 1/27/2020

    There have long been numerous global and local regulations for how nuclear materials are transported, compounded, monitored, and dosed for the purpose of diagnostic evaluation. These continue to be applicable for both diagnostic and therapeutic nuclear medicines. However, establishing therapeutic medical claims for nuclear medicines increases the list of regulations that must be followed.

69. New Neuroscience-Based Human Factors Research Methods Will Improve Devices’ HFE Performance, Simplify FDA Approval 6/4/2018

    HFE testing, as a professional discipline, has not taken advantage of a wide range of advanced and well-understood  physiological, biomechanical, cognitive, and emotional sensing and testing modalities.

70. 4K Operating Room Technology Advancing, Despite Initial Doubts 8/8/2018

    As the minimally invasive approach continues to become standard procedure, demand for surgical visualization equipment will continue to rise. Continued adoption of 4k technology is bolstering growth in the total U.S. video and integrated operating room equipment market, which currently is valued at almost $2.3 billion.