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WHITE PAPERS AND CASE STUDIES

• 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.

• Driving Customer Profitability With Enterprise Platform, Pricing

  Explore how the solutions and approaches offered by CDS can help different research stakeholders conduct more cost-efficient clinical trials in the industry's pharmaceutical, biotech, and device sectors.

• A Paperless Lab Simplifies, Accelerates Full Sample Lifecycle Data Management

  Implementing IDBS’ ELN helped Crown Bioscience realize electronic experimental records, optimizing our business processes and helping them to be more standardized.

• 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.

• 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.

• Expand Bandwidth With A Trusted Regulatory Writing Partner

  Find out how a mid-size biotech lacking the bandwidth, expertise, and resources to independently handle its regulatory writing requirements overcame this challenge.

• Master Protocols: Implementing Effective Treatment Adaptations

  From balancing treatment ratios and managing eligibility to accommodating site-specific readiness and protocol amendments, a well-designed IRT system enables seamless transitions.

• Study Start-Up Challenges: Hard Realities, Effective Strategies

  Launching a study is complex, and the time between protocol approval and the first patient visit has increased dramatically. How can companies reverse this trend and accelerate study start-ups?

• Modular Automation: The Plug-And-Produce Opportunity For Life Sciences

  Explore how the advantages of modular automation in life sciences emphasize flexibility, efficiency, and cost savings through plug-and-produce systems that enhance production adaptability and speed.

• 2024 Global Biopharma Sustainability Review

  What steps is the biopharma industry taking to enhance sustainability? What challenges does biopharma encounter? And how can the entire industry draw lessons from the companies setting the standard?

• Generation Of A Contamination Control Strategy

  An unaddressed compliance issue related to contamination control can pose a significant risk to a life sciences organization. This case study details a company's journey toward sustainable compliance.

• Validation Provider Shortens The Path To Equipment Qualification

  Explore the partnership enabling Transcat to meet regulatory requirements while focusing on core R&D and accelerating the delivery of life-changing therapies.