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WHITE PAPERS AND CASE STUDIES

• Transforming Environmental Monitoring And Sample Management

  Discover how applying an OpEx framework to environmental monitoring and sample management can optimize workflows, improve resource utilization, and deliver measurable annual cost savings.

• 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.

• Reducing Lead Time, Delivering >99.5% OTIF

  Explore the stocking solution offered to a mid-sized CDMO in need of a high volume of safety stock inventory to support their customer portfolio growth.

• The City Of Fayetteville's Flood Resiliency In The Face Of Climate Change: Mapping 15 Watersheds

  The city of Fayetteville, North Carolina has always had flooding issues, but it’s been getting worse as weather patterns have been changing. They were hit four years in a row by storms Matthew (2016), Irma (2017), Florence (2018), and Dorian (2019). 

• Revolution In The EU Pharmaceutical Legislation Ahead

  Discover the impact revised pharmaceutical legislation will have on the industry by superseding regulations that have fostered the availability of safe and effective medicines for the past two decades.

• ICH E6(R3) In Effect: Transforming Quality Management For CGT Trials

  Discover how the updated ICH E6(R3) guideline supports the speed and complexity of CGT manufacturing, enabling flexible, risk‑based decisions and quality systems built to scale therapies safely.

• 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.

• 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.

• 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.

• A Toolbox For An Effective Tech Transfer

  As drug development costs rise, companies are embracing digital-first strategies and Pharma 4.0 principles to streamline operations, enhance tech transfer, and accelerate time-to-market through innovation.

• 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.

• Single-Use Assembly Capabilities To Keep Pace With Biopharma Dynamics

  Discover how a vendor-independent partner assists global life science companies and CDMOs with innovative single-use technologies to mitigate risks and ensure uninterrupted manufacturing.