Healthcare

WHITE PAPERS AND CASE STUDIES

• Buffers And Process Liquids For Biopharmaceutical Production: Considerations For Scale-Up And Outsourcing

  For small and midsize biopharmaceutical organizations, outsourcing buffer and process liquid preparation, quality testing, and storage could significantly streamline operations and reduce regulatory risk.

• 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).

• Maintaining Quality And Regulatory Compliance To Support Rapid Global Growth

  Discover how Huvepharma, a global pharmaceutical company, implemented software to standardize quality management processes across its manufacturing sites, enhancing compliance and efficiency.

• 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.

• Taking Research In-House With CRIO: SciTech's Multi-Center Phase 1 Study

  Explore the success story of an early-stage clinical pharmaceutical company that effectively navigated funding constraints when conducting its Phase 1 study without a third-party CRO. 

• 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.

• 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.

• Streamline Your mAb Manufacturing With Strategic Development And CDMO Compatibility

  Though the journey to mAb development begins at lab scale, for clinical trials and commercial distribution, a production process must be streamlined and scalable to 2,000 L production and above.

• Decentralized And Community-Based Solutions Driving Women's Healthcare

  Clinical trials should reflect the affected population by reducing participation barriers and bringing trials to patients to increase inclusion and improve real-world data.

• Optimizing EDC Strategy And Data Collection for a Rare Disease Trial

  Explore how Veristat created a forward-looking roadmap for EDC and CRFs integration for a small biotech sponsor, ensuring a future-ready data ecosystem without overcomplicating current operations.

• Leveraging Life Sciences Data For Intelligent Decision-Making

  Industry 4.0 drives life sciences to prioritize data-driven decision-making by integrating advanced technologies in QMS. Discover how modern data management can improve compliance.

• 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.