Healthcare

WHITE PAPERS AND CASE STUDIES

• What Is ICH GCP, And How Does It Impact Clinical Planning?

  The updated ICH GCP guideline modernizes clinical trial standards, aligning with today’s technologies to enhance participant safety, data integrity, and risk-based trial design.

• Sustainable Solutions For Medical Devices

  Explore how medical device companies aim to balance patient safety with environmental stability by offering bio-based UHMWPE, which reduces carbon footprints by up to 70%.

• Understanding Real-World Patient Characterization And Safety Outcomes Of DEXTENZA

  In this study, we can derive confirmation of DEXTENZA’s favorable safety profile across a broader surgical spectrum.

• Developing Effective Procedures

  Effective procedure development starts with understanding the purpose and should integrate change management, risk management, and knowledge management to ensure a robust quality system.

• How Medidata Link Is Supporting Moderna's Clinical Trial Real-World Data Linkage Initiatives

  Discover how Medidata Link empowers Moderna's clinical trial RWD linkage initiatives, enhancing insights into treatment outcomes while minimizing administrative burdens.

• Leveraging Single-Use Solutions To Solve Working Cell Bank Challenges

  Discover how custom manifolds enhance allogeneic therapy development from formulation to commercialization by improving process control, scalability, and efficiency.

• 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.

• 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.

• Examining A Phase 1 COVID-19 Clinical Trial

  Uncover how we were able to efficiently activate the site and enroll 130 participants within six months, demonstrating our expertise in clinical trial management.

• Oligonucleotide Synthesis: Scale-Up Made Simple

  Scaling oligonucleotide synthesis isn't as straightforward as it seems. Explore key challenges, critical process parameters, and solutions for a smooth scale-up.

• Escondido, CA Uses Cityworks And Esri's ArcGIS® For Its Asset Management System

  Read about water utility managers who took advantage of an offer from Trimble to do a pilot program for creating a ‘system of action’ that focuses on leveraging their investment in Esri’s ArcGIS® and water sensor data, location intelligence, and analytics tools.

• 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.