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WHITE PAPERS AND CASE STUDIES

• Writing An IND Module 3 For Cell And Gene Therapy Products

  This whitepaper outlines the critical considerations for CGT Investigational New Drug (IND) Module 3, as well as how to avoid clinical holds and ensure regulatory readiness.

• CRO Collaboration That Fuels Innovation For Specialty Biotechs

  Delve into the advantages of specialty CRO collaborations and the strategic opportunities that lie ahead as the life sciences field continues to embrace innovation and collaboration.

• Multiple Fill Line Delivery Experience

  Learn how a multinational pharmaceutical company successfully implemented a global strategy for insulin cartridge filling, achieving seamless regulatory approval with zero deviations.

• HOT SWIR Detector Technology For Both Passive And Active Imaging Applications

  Collins Aerospace Princeton advances SWIR photodetector arrays with innovations in dark current reduction, hybridization, avalanche photodiodes, and fabrication processes for improved performance.

• Isolator Vs. Optocoupler Technology

  While optocouplers have been the dominant signal isolation solution for a long time, a new breed of higher-performance CMOS isolator solutions will ultimately out-mode the venerable optocoupler.

• Closing The Gap In Our Understanding Of Sleep Health With DHTs

  What is the current state of sleep assessments in clinical trials, regulatory expectations, and what opportunities do wearable digital health technologies present?

• Patient Perspectives On eConsent

  Explore how eConsent enables participants to engage meaningfully with consent documentation, addressing information dissemination, explanation, and recall challenges.

• Organizational Assessment For A Large MedTech Company

  Explore an organizational assessment run for a medical technology company specializing in tissue repair and regeneration, and the actionable recommendations provided to facilitate future growth.

• RO Membranes' Protection At Pinghu Power Plant, China

  A power plant in Pinghu, Zhejiang Province in China needed to replace the use of chemical biocides and protect boiler feed make-up water from anaerobic and aerobic bacterial growth and associated biofouling.

• Owen Mumford Slashes Audit Findings, CAPAs, And NCRs

  Gain insights into how Owen Mumford, a global medical device leader, enhanced their compliance and efficiency with software to reduce audit findings and improve quality management.

• Alerion Microbubble Cell Separation System Used For T Cell Negative Selection

  Discover how the Alerion™ Microbubble Cell Separation System outperformed standard magnetic methods in T cell recovery, speed, and scalability — achieving higher cell quality with Akadeum’s innovative microbubble technology.

• Intelligent Automation For MDR & IVDR Content

  Learn how automation can help fulfill new MDR/IVDR requirements and optimize existing labeling and documentation operations while meeting compliance.