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WHITE PAPERS AND CASE STUDIES

• Advanced Formulation Development By Design: Holistic Drug Production

  Drug substance/drug product biomanufacturing complexity is increasing. Solving challenges calls for innovative mindsets, advanced technology, and proficient and complementary expertise.

• Direct-From-Patient Data Capture With eCOA

  Learn how an eCOA tool can provide patients a chance to be heard while giving sponsors quantitative and qualitative data to track the efficacy of a treatment.

• Predict, Forecast, And Optimize Your Workforce In Real-Time

  Matching team resources with fluctuating demand over multiple time horizons is a tough challenge. Organizations need real-time flexibility for scenario planning, coupled with forward visibility to strategize effectively and provide best-in-class service.

• Duni Wipes Out Manual Work With MediusFlow

  Duni manufactures and distributes innovative tabletop concepts, creative packaging and take-away solutions for professionals and consumers in more than 40 countries across the globe. The company processes approximately 100,000 invoices per year through MediusFlow’s AP automation solution connected to SAP.

• Go Digital, But Make It Effortless: Pharma Recipe Authoring

  Explore some of the most commonly encountered challenges associated with recipe development and how going digital enables companies to turn molecules into medicine in a fraction of the time.

• Artificial Intelligence Can Boost Reliability And Speed Of Medical Imaging Analysis In Clinical Trials

  Pharmaceutical firms face many challenges in bringing their products through clinical trials — from enrollment delays to data quality issues — and every advantage can make a difference. In image analysis, sponsors can gain a critical advantage by leveraging artificial intelligence (AI) or machine learning (ML) — computer solutions that mimic human intelligence and are continually enhanced and updated to become more accurate as they take in more data.

• Steps To Paperless Clinical Research Sites

  This paper presents insight and expertise on how investigative sites can begin the transformation to digital documents, including concrete, practical suggestions for eliminating the inefficiencies inherent in printing, storing, and managing paper documents.

• Emulating Integrated Air Defense System

  Doctrine, threat, tactics, availability, and readiness of equipment and people are just some of the variables considered in establishing an integrated air defense system (IADS) in and around an airfield. For this case study, D-TA Systems created a fictitious laydown in Syria of Russian and Syrian forces and used D-TA’s MRSE elements to make an open-air range of a realistic battle space.

• New Metrology Techniques For Advanced Thin Film Optical Filters

  Alluxa’s thin film optical filter technology has advanced to the point where the spectral slopes and blocking levels are challenging even the best metrology equipment and techniques. This paper discusses challenges and provides solutions for measuring the spectral response of this new class of high-performance filters.

• Tekton Research Experiences A 'No Findings' FDA Inspection

  As COVID-19 increased its impact on research collaboration and monitoring in 2020, Tekton Research’s desire to move to full remote monitoring intensified. The research site soon realized there was a need for a remote source document monitoring solution --– one that would enable the upload, management and sharing of source documents with monitors and sponsors without redacting sensitive patient information.

• Clinical Data Transparency & Public Disclosures: Overcoming Challenges With Prospective Writing

  If a prospective approach is applied while preparing one document, it can support the creation of the other documents at a later stage. In this paper, we will discuss the development of document connections while preparing material for internationally regulated disclosure and how to apply this information.

• 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.