Healthcare

WHITE PAPERS AND CASE STUDIES

• From Paper To Digital Study Management In Large Patient Registries

  Uncover how this sponsor was able to independently design and oversee its clinical study, minimizing external assistance, and easing the workload for their sites through mobile app accessibility.

• What Does Pharma 4.0 Mean To Cell and Gene Therapy Drug Manufacturers?

  Explore the benefits of Pharma 4.0 for CGT companies along with the challenges they may face when implementing the convergence of people, systems, and data within a singular network.

• Paper Vs ePRO: Clinical Data Collection Methods

  Patient-reported outcomes (PROs) assess patients' health without clinician interpretation. Traditional paper methods often result in missing data and quality issues, while electronic solutions enhance data accuracy and completeness.

• Choosing An R&D Data Management Platform For Novel Antibody Therapeutics

  Uncover how this collaboration ensured the implementation of a robust electronic system that streamlined R&D operations, increased data integrity, and ultimately supported the development of novel antibody-based therapeutics.

• Empowering Freenome: Large-Scale Data Quality And Compliance

  Delve into five ways this biotech company was able to successfully deliver data quality and compliance for large-scale trials while developing next-generation blood tests for early cancer detection.

• Patient Diversity: Identifying Challenges, Opportunities, And Best Practices

  By listening to the voice of patient diversity and implementing FDA guidance measures, learn how stakeholders can improve trust, engagement, data reliability, patient outcomes, and promote public health.

• 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.

• 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.

• Designing For Diversity

  Embracing diversity enhances our understanding of humanity, fostering empathy and a broader perspective on the world's cultures and behaviors.

• Earning RMAT Designation - What Developers Need To Know

  Explore a high-level overview of the Regenerative Medicine Advanced Therapy designation and how to ensure success and accelerate advanced therapy products toward commercialization.

• Case Study: Development Of A Plastic Capillary Blood Sampling Device

  This brief paper describes the work undertaken by Axis-Shield PoC A/S and Carclo Technical Plastics to develop an innovative solution, thereby improving an existing product and significantly reducing cost.

• Novo Nordisk Harmonization Of Quality And Change Management

  See how Novo Nordisk, a global biopharmaceutical company, transitioned from a paper-based Quality Management System to an automated solution to enhance efficiency and compliance in change management.