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WHITE PAPERS AND CASE STUDIES

• 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.

• Leading European CDMO For Drug Product Manufacturing

  As timelines tighten and regulatory demands grow, discover how a European CDMO delivers integrated solutions from aseptic fill and finish to packaging and release.

• Sickle Cell Cure Within Reach, But At A Steep Cost

  Treatment options for sickle cell disease (SCD) and newly available gene therapies represent a potential cure. However, the latter are costly and thus remain out of reach for many SCD patients.

• OEE And Product Inspection

  Explore the calculation of Overall Equipment Effectiveness (OEE) and the impact of product inspection equipment on OEE in the pharmaceutical industry.

• Connecting Quality Management, Patient-Centricity, And Business Value

  Examine why organizations must integrate data and processes to enhance quality and insights to improve operational efficiency, patient health, and regulatory compliance.

• Rapid Startup Phase 1 Cardiomyopathy CRISPR Gene Therapy

  Hereditary transthyretin amyloidosis (ATTRv) is very rare, prompting a Phase 1 trial of in vivo CRISPR/Cas9 gene editing to reduce mutant protein and stop cardiomyopathy progression.

• How LIMS Supports QC Scaling At Forge Biologics

  Modernizing QC workflows with cloud-based systems eliminates paper inefficiencies, reduces errors, and accelerates reporting. Discover how streamlined processes improve compliance and enhance data visibility.

• PV Solutions Optimizing End-To-End Safety In Clinical Development

  Explore what the future of PV services and technology in the life sciences industry could look like if innovation, regulatory vigilance, and collaboration with regulatory bodies were prioritized.

• Rethinking Clinical Operations: A Smarter, Faster Playbook For Trial Success

  The CRO-sponsor partnership is now strategic, addressing communication gaps and fragmented systems to improve efficiency. Joint governance, real-time tracking, and unified technology accelerate complex trial execution.

• Advancements In Microbial Manufacturing Of Biopharmaceuticals

  Dive into the evolution and future potential of microbial manufacturing in the biopharmaceutical industry to discover how digital tools can revolutionize development and production processes.

• The GxP Digital Maturity Model

  Explore how the GMP Digital Maturity Model guides life sciences companies through five stages to improve compliance, efficiency, and profitability with strategic digital adoption.

• Using Virtual Study Coordinators For EDC Entry And Query Resolution To Speed Up Data Access And Cleaning

  The piece showcases how the effective use of CRIO can significantly enhance site performance, supporting recruitment and diversity objectives for sponsors.