Healthcare

WHITE PAPERS AND CASE STUDIES

• 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.

• Catalent's Journey Of Continuous Improvement For CSV Excellence

  Learn how organizations must continuously reassess validation processes and digital tools to ensure compliance, enhance efficiency, and support global scalability amidst evolving regulatory expectations.

• Validation Provider Shortens The Path To Equipment Qualification

  Explore the partnership enabling Transcat to meet regulatory requirements while focusing on core R&D and accelerating the delivery of life-changing therapies.

• Patient-Focused Data Capture For Cancer Research

  In a field where innovation is constant and patient experience is pivotal, oncology demands eCOA solutions designed to balance scientific rigor with human realities.

• The Promise Of PCM: Getting To Maturity

  PCM offers a number of advantages, including streamlined development and increased flexibility. Review the key drivers for PCM as well as the hurdles that stand in the way of industry-wide adoption.

• Robust Models For Supporting PV And Medical Information Activity

  Learn how outsourcing local pharmacovigilance and medical information activities to an established safety organization can provide high-quality expertise and technology that meets demand.

• 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.

• 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.

• The Evolution Of Clinical Operations And The Growth Of FSP Partnerships

  Explore the integration of new technologies, the FSP’s role in promoting patient diversity, and how clinical operations leaders are increasingly becoming thought leaders within the industry.

• Operational Considerations For EU Clinical Trial Readiness & Execution

  Gain a comprehensive understanding of the Clinical Trial Regulation (EU) 536/2014 (CTR), which has equipped stakeholders to navigate the altered regulatory landscape and prepare for conducting clinical trials in the EU/EEA.

• Providing Packing And Blinding Solutions For An Innovative Drug Start-Up

  Discover how a CDMO with integrated services enabled a botanical drug start-up to commence its Phase 1 clinical trial, paving the way for further advancement of its innovative botanical drug.

• Not Your Typical MES: The Ultimate Guide To Made With MX

  Life sciences manufacturing is evolving rapidly. Discover how digital transformation is revolutionizing production processes to enable personalized medicine and improve patient outcomes across the healthcare industry.