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WHITE PAPERS AND CASE STUDIES

• Advancing Oncology Development With A Synthetic Control Arm Trial

  A specialized biopharmaceutical company had a breakthrough therapy that had the potential to be first-in-class for a rare and aggressive hematological cancer and had shown great potential in earlier clinical trial. In many breakthrough treatment areas, where the patient population is small, or there is overwhelming evidence of efficacy at Phase 2, it has become common for drugs to be approved based on a pivotal single arm trial – however, this is not always optimal. Read how synthetic control offers a practical, effective way to leverage real-world evidence and has been applied in regulatory approvals.

• Lipid Formulations To Enhance Bioavailability In Early Development

  To prevent delays and costly issues during molecular development, it is important to understand potential mechanisms of increased absorption with lipid formulations and the appropriate screening tools.

• Yesterday Was “Business-as-Usual”; Today Is COVID-19 “Survival”; Tomorrow Will Be Long-Term “Sustainability”

  The survey findings reported and analyzed in this paper should provide a strong sense of the individual patterns and trends that characterize the industry and help to support a more full understanding of where the market stood at the outset of the pandemic.

• Phantom Goes To MIT: A Series Of Case Studies

  High-speed photography is alive and well at the Massachusetts Institute of Technology (MIT) Edgerton Center. The Center makes high-speed imaging equipment available to students to help further their education in science and engineering.

• Clinical Supply Optimization: Enhanced Service Model Saves Client Time On Supplies

  The Vice President of manufacturing for a clinical-stage biopharmaceutical company faced an avalanche of work when a reorganization left him without a clinical supply manager. Planning to start 5 new clinical trials in 6 months while managing quality assurance, manufacturing, and supplies for new and ongoing studies, he turned to his Fisher Clinical Services account executive with a simple question: “How am I going to do all that?”

• Understanding The Full Potential Of Best-In-Class Warranty Management

  For a business to succeed in a world of increasingly powerful service technologies, getting Warranty Management right is the bare minimum. Forward-thinking firms take that a step further, unafraid to make warranty management another tool that they can use to gain and retain customers.

• Single IRB Review For Multicenter Research: A Guide For Institutions

  Single IRB review for multicenter research is now the norm in the US. Initiatives that are requiring harmonization between the FDA regulations and the Common Rule have made it clear that the federal agencies favor centralized review by a single IRB for multicenter research. Download this guide to find out about issues your institution should consider as the research community evolves into the new landscape of mandated centralized IRB review.

• Practical Considerations Of A Successful RBQM Implementation

  Advances in technology, such as electronic capture and storage of study data and documentation, have accommodated the growing reliance on RBQM for clinical trials. With any new technology, there are questions about implementation and best practices.

• Innovation In AR Lens Coatings: High-Quality Coatings For High-Power Lasers

  Coatings must protect the lens and allow for the highest levels of optical performance, with low levels of absorption and a long life expectancy, while also exhibiting appropriate transparency and an acceptable cost/benefit ratio.

• When Failure Is Not An Option

  The manufacture of Intelligence, Surveillance, & Reconnaissance (ISR) optics requires a rigorous analysis of the capabilities and methods of an optical component design/manufacturing partner. Not all design/manufacturing partners are the same, and it is important that integrators elect to work in a collaborative way with companies that have the expertise, pedigree and capabilities to scale up production of components in an accurate and repeatable way.

• 5G Antenna Design For Smartphones

  Over the past 10 years, smartphones and smart devices have transformed the way we communicate, are entertained and carry out our work. Over 1 billion devices are sold each year and around half the world’s population own a smartphone. 

• BV Dairy Unleashes Growth With Epicor ERP And DocStar

  Founded in 1958 as a family farm in England’s West Country, BV Dairy is now a thriving modern business. Each year, the company purchases 35 million liters of milk from dairy farms within a 25-mile radius of their production facility in Shaftesbury, Dorset and turns them into dairy products for food distribution and manufacturing firms. BV Dairy’s range includes their award-winning Dorset clotted cream, as well as yogurts, buttermilk, soft cheese, and mascarpone.