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WHITE PAPERS AND CASE STUDIES

• Biotech Delivers A Superior Patient And Site Experience

  To become the sponsor of choice for sites and patients in congenital hyperinsulinism clinical trials, a small biotech company prioritized delivering a superior experience while streamlining operations.

• Compliance Auditing: Diving Into Common Critical Findings

  Review critical findings in compliance audits, highlighting frequent issues, their impact on operations, and steps companies can take to improve regulatory compliance.

• Non-Viral Genetic Modification Using The 4D-Nucleofector LV Unit In CGT

  This paper underscores the 4D-Nucleofector® LV Unit as a pivotal tool for translating genetic modification technologies into scalable, safe, and effective therapeutic solutions.

• How Digital Transformation In Sample Management Increases Efficiency

  Explore a real-world example of how a dynamic and growing CDMO implemented a lab management system to improve efficiency and data integrity for their quality control sample management workflows.

• Achieving Excellence In Clinical Research And Quality Management

  Lotus Clinical Research, founded in 2001, leverages regulatory expertise and digitalization to enhance quality, automate processes, and improve compliance in biopharmaceutical clinical trials.

• Support Digital Transformation And Enable Collaboration Between Teams

  Discover the solution PharmaEssentia, a Taiwanese pharmaceutical company, chose to help teams capture, structure, and interrogate data from a single source, making their collaboration more efficient.

• Lean Six Sigma Methodology Drives Cost Savings: 2 Success Stories

  Unlock significant lab efficiency and financial gains. See how focused optimization of workflows and asset management led to substantial cost savings and reclaimed six-figure value in consumables.

• How Digitized Protocols Are Accelerating Clinical Research

  Digitized protocols, enhanced by artificial intelligence (AI), are transforming clinical trial operations by accelerating document generation, system integration, and trial optimization.

• Mobilizing Compliance: USP 797 And 800 Pharmacy Trailer Fleet For VA Hospitals

  VA hospitals across the US are undergoing renovations to bring their facilities into compliance. The challenge was to design and manufacture a fleet of self-sufficient mobile compounding pharmacies.

• Symmetry Surgical Uses Software To Enhance Quality

  Symmetry Surgical enhances operations and quality management using software to improve efficiency, compliance, and data-driven decisions while producing over 2 million surgical devices annually.

• Bringing Clinical Testing To New Heights In New Jersey

  Explore how clinical testing was transformed with a pioneering BSL-2 mobile laboratory on a Sprinter Van platform to enhance safety and portability for advanced biosafety requirements.

• Development And Optimization Of Suspension-Adapted 293T Cell Line

  Learn how an adapted cell line can reduce costs and improve scalability in the production of lentiviral vectors for CGTs and examine its potential to produce GMP-grade lentiviral vectors.