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WHITE PAPERS AND CASE STUDIES

• Advancing Cell And Gene Therapy Clinical Development In 2023

  Examine considerations on bringing together the CMC and clinical teams early in the development process, promoting transparency and communication with regulators, and increasing patient access and diversity in clinical trials.

• PlantPAx Distributed Control System Reduces Downtime For Mallinckrodt

  Learn how the nation's leading supplier in prescription pain medication completely upgraded their control system, resulting in greater diagnostic/troubleshooting information and reducing downtime.

• Site Satisfaction: Influencing Tech Development Strategies

  Technology is playing an increasingly important role in clinical trials, helping to improve efficiency, compliance, and data quality. Learn why it’s critical that clinical study technologies are easy to use across sites and fit into the team’s workflows.

• Improving The Advanced Therapies Digital Landscape

  Discover how ProPharma transformed a rapidly growing biotech company's data governance and systems architecture to enhance efficiency and data integrity.

• Safeguarding Personal Data: Protecting PII

  Learn about a secure, patient-centric platform that enables individuals to participate in clinical trials and registries while maintaining lifelong access to their data.

• Phase 1 Clinical Trial Designs And Strategies

  With tailored guidance, sponsors can align their modern model-based and model-assisted design choices to program goals, accelerating progress while safeguarding patients.

• Electronic Batch Reporting

  Learn how a CDMO automatically created a comprehensive batch report model to drive their reporting and speed root cause identification of quality failures with an Industrial DataOps software solution.

• A Guide For Quality Professionals In Healthcare And Life Sciences

  Discover a guide for quality professionals that highlights essential principles and strategies for maintaining data accuracy, compliance, and innovation to ensure high-quality data in healthcare and life sciences.

• eCOA: Unified Approach Streamlines Processes, Speeds Start Up And Improves Data Quality

  Discover how a leading biopharmaceutical company revolutionized its clinical development with an eCOA solution that optimized its processes, cut build times, and enhanced data quality.

• Improve Your Molecular Cloning Process With Synthetic Biology Automation

  Explore the promising field of synthetic biology, the hurdles manufacturers face with it's workflow, and how automation can help accelerating throughput and walkaway time.

• Digital Biomanufacturing, Now: From Digital Dreamer To Digital Doer

  Discover how digital biomanufacturing is revolutionizing drug production by exploring strategies for integrating digital technologies to enhance efficiency and innovation in bioprocessing workflows.

• Enabling Quality By Design

  Outdated quality systems delay product release. Discover how manufacturers can harness real-time data, operationalize QbD, and enhance compliance, efficiency, and supply chain continuity.