Healthcare

WHITE PAPERS AND CASE STUDIES

• Building A High-Quality IND From Scratch With Strategic Gap Analysis

  A biotech sponsor lacking in-house regulatory expertise engaged a partner to obtain strategic regulatory review, medical writing, project management, and electronic publishing (eCTD).

• Why Early Market Access Planning Is Crucial In CGT Commercial Strategy

  Bringing cell and gene therapies (CGTs) to market and ensuring patient access is a complex process. Discover how developing a market access strategy and partnering with experts can help.

• 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.

• Digital Solutions Enhance Pharmaceutical Manufacturing Performance

  Personalised therapies and advanced technologies are reshaping manufacturing. Explore how intelligent automation can improve flexibility, strengthen data integrity, and accelerate production.

• Unveiling The Critical Role of Sleep In Clinical Studies

  Explore the critical role of sleep in clinical trials and its impact on health outcomes, emphasizing the need to address sleep disturbances for more effective and reliable research.

• Verve Puts Digital-First Quality At The Heart Of Its QC Lab

  Learn how a biotech scaled faster by building a paperless lab, adopting cloud-based LIMS, and streamlining QA/QC processes to reduce errors, improve efficiency, and enable real-time collaboration.

• Automated Evidence Generation For Regulatory-Grade RWD

  Global regulatory agencies increasingly adopt Real-World Evidence, demanding higher data quality and automated AI-driven platforms to meet evolving standards and improve drug development pathways.

• Automated Validation And Centralized Data

  Discover how intelligent CPV, powered by automation and real-time analytics, is transforming manufacturing by driving quality, compliance, and innovation in a rapidly evolving regulatory landscape.

• Overcoming Participant Compliance Challenges In A Medical Device Study

  Uncover how Catalyst Clinical Research enhanced participant compliance and streamlined scheduling for a TENS device study using the TrialKit platform, with crucial support from CDS.

• MilliporeSigma's 97-Day Implementation Success Story

  Read how MilliporeSigma transformed validation processes with a digital validation system to achieve compliance in just 97 days, as well as learn key takeaways from their swift transition.

• 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.

• Creating Sustainable Data In The Laboratory

  In a laboratory setting, data is everywhere. Learn in-depth about data challenges, the importance of data lifecycle management in laboratories, and the need for data sustainability.