Sharepoint Solutions

WHITE PAPERS AND CASE STUDIES

• Case Study: Truly "Focused On Faster" For Aseptic Filling

  As pharmaceutical companies develop therapies targeting rare diseases, more small batch projects are emerging, along with an increase in outsourcing projects with short lead times for aseptic filling. This case study presents a small, research-focused biotech company that quickly needed their finished drug product clinical supplies delivered to their distributor.

• Lenovo Generates Significant Net-New Revenue In 6-Week Period With Katapult’s Innovative Financing Options

  Lenovo teamed up with Katapult to provide a lease-to-own financing option for this sub-prime customer segment. In the first six weeks after implementation, Lenovo generated incremental revenue through the new Katapult offering. Over the next few months, as the Katapult and Lenovo teams continued to optimize the new offering, completed originations from pre-approvals increased by 25 percent.

• MBR System Treats Nut Processor’s High Strength Wastewater With Ease

  The macadamia nut is indeed favored by many as a high quality nut, evidenced by its extensive use in desserts or simply as a premium stand-alone snack. One of the world’s leading producers of these delicious nuts produces more than 15 million pounds each year from its Hawaii processing plant.

• Five Easy Investigator Payment Fixes To Improve Site Relations

  Site satisfaction is closely linked to the frequency, accuracy and timeliness of clinical trial payments. Yet making payments has long been a challenging process between sponsors and sites. This white paper reviews five common issues that delay site payments and offers recommendations to resolve these issues, improving payment efficiencies and ultimately site satisfaction.

• Establishing Risk-Based Monitoring Within A Quality-Based System As “Best Practice” For Clinical Studies

  This report based on a survey of ACRO members reveals that Risk-Based Monitoring (RBM) makes clinical trial quality review more efficient and effective. It found that when a company reviews data through a centralized system using the RBM model, CROs and technology companies are better able to detect quality issues earlier and make rapid corrections at the site level. This type of approach is now central to ensuring the safety of patients in clinical trials, and is expected to continue to grow in importance as clinical trials becomes more numerous and complex.

• Implementing Review-By-Exception RtReports For Manufacturing At BioMarin

  In streamlining its batch review process, BioMarin reduced burdens on both its quality assurance and engineering teams while simultaneously speeding its products’ time to market.

• Advanced Methods For Analyzing Ultra-Wide Automotive Radar Signals

  Automotive FMCW radars typically operate between 76 GHz and 77 GHz. In some countries, the frequency range between 77 GHz and 81 GHz has become available for automotive radar applications. This paper will review different ways to overcome the challenges of RF measurements in the E band for ultra wide signals. It will look at the demodulation and analysis of a wideband automotive radar signal and discuss the results and main performance parameters.

• Aerzen Steam Blower Case Study

  ZLD (zero liquid discharge) is a wastewater distillation process that helps reduce waste brine discharge to the environment and recover the majority of the wastewater as clear reusable water. In addition, it can turn the brine to a solid waste and in some cases even a useful product that can be profitably sold.

• Biopharma Accelerates Lab Digitalization With BIOVIA One Lab

  A biopharma company’s experimental records, recipes and scientific results were stored in multiple Excel files, scanned PDF documents and siloed lab solutions, many of which did not use the same conventions from lab to lab or scientist to scientist. disconnects were leading to additional lab work at late stages, workflow inefficiencies, long review times, delayed decisions, excessive effort and wasted material. They needed to implement a common solution across all CMC labs and for all therapeutic modalities—both small molecules and biologics.

• Regulatory Compliance: An Increasing Burden On Sites

  As the biopharmaceutical industry strives to reduce its R&D costs and shorten timelines, it must face the fact that today’s successful drug development plans often require more clinical studies than they did a dozen years ago. But a new CenterWatch survey, sponsored by Complion, sheds some light for the first time on how, and how well, sites manage regulatory compliance.

• TITAN MBR™ Microfiltration Provides Private Development Site With Water Reuse Capabilities

  When developers of a condominium complex sourced wastewater treatment systems, it did so with two primary requirements: efficient land utilization and high effluent quality to meet stringent guidelines. State regulators advised the developers to discuss combining its wastewater system with the owner’s association of an adjacent housing development, whose existing wastewater treatment system was aging and required augmentation.

• Ethical Considerations In Adaptive Design Clinical Trials

  While adaptive design is associated with many potential benefits, it may also present challenges to observing the basic ethical principles of research in human subjects. In this white paper, we review the features of particular clinical trial design adaptations and discuss the ethical obstacles they can present and those they can potentially resolve. Using examples of both published and unpublished clinical studies, we highlight the importance of proper design and planning and appropriate ethical due diligence in the successful conduct of an adaptive design clinical trial.