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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.

• Building A Legacy In Sterile Injectables Through Strong CMO Synergy

  Examine how a CMO can deliver significant value to drug developers by fostering successful outsourcing relationships, streamlining the path to market, and supporting demands.

• 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.

• Global Resourcing Maximizes PV Operations To Meet Timelines

  Explore how clients were able to leverage the extensive resources of PPD FSP Solutions to maximize their PV operational delivery model and successfully meet ambitious timelines.

• 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.

• The Smart Industry Readiness Index: A Path To Achieving Digital Maturity

  In a time defined by the Fourth Industrial Revolution (Industry 4.0), a period transforming industries through advanced technologies, the manufacturing landscape is evolving beyond something we recognize as familiar. With the potential to automate processes, enhance data visibility, optimize operations, and redefine value chains, technology is revolutionizing industries across the globe. However, many organizations grapple with a critical question: How can they assess their digital transformation (DX) readiness for this most important paradigm shift?

• Streamlining Study Start-Up For Accelerated Drug Development

  What is the secret to safely expediting study start-ups? Explore our case study to find out how open dialogue, aligned expectations, and direct communication between Altasciences’ team leads and sponsor contributed to a clinical trial start-up of only 3.5 weeks.

• Accelerating CRO Study Deployment At Scale

  A top-3 CRO and a top-10 pharmaceutical company partnered with Medable to help accelerate, scale, and standardize their eCOA trials. See how they accomplished it.

• How To Get Products To Patients Faster With A Connected QMS

  BioBridge Global faced challenges with paper-heavy processes that risked errors and delays. Discover how digital solutions streamlined their operations and improved regulatory efficiency.

• 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.

• Meet Regulation Requirements With RTU Vials And Cartridges

  Sterile manufacturing remains vital, with resilient supply chains preventing shortages. Industry and regulators prioritize integrity as demand surges, making it the fastest-growing pharmaceutical segment.

• 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.