Business Process Management

WHITE PAPERS AND CASE STUDIES

• Developing And Validating Clinical Receptor Occupancy Pharmacodynamic Biomarker Assays

  Receptor occupancy (RO) assays assess drug-target engagement and support PK/PD modeling. Accurate RO requires customized assays using stabilized blood to monitor CD6 modulation in autoimmune therapy.

• Converting iPSC To T Cells: Key Challenges And Considerations

  Explore how by addressing challenges in differentiation, clone selection, and manufacturing, iPSC-based T cell therapies could revolutionize cancer treatment and other diseases.

• Build An AAV8 Platform: Lessons From A Collaborative Development Journey

  Explore how a modular AAV8 platform enables scalable, GMP-ready gene therapy manufacturing with reproducible outcomes, streamlined tech transfer, and adaptability across serotypes.

• Flexible Fill/Finish Solutions To Bridge The Clinical-To-Commercial Gap

  As biopharma complexity grows, flexible CDMOs are essential for navigating evolving fill/finish needs, accelerated timelines, and regulatory uncertainty with agility and expertise.

• The Patient Recruitment Shift: Navigating Disruption, Delivering Precision

  Explore the four macro trends reshaping the recruitment space in 2025—each grounded in emerging data, technology, and behavior shifts.

• Avoid Clinical Manufacturing Pitfalls With These Tech Transfer Best Practices

  Ensure a smooth transition from development to manufacturing by implementing a strategic tech transfer process. Review key practices for effective communication, collaboration, and risk mitigation.

• Digitalizing Batch Records In Pharmaceutical Production

  Pharma manufacturing embraces cutting-edge automation, yet outdated paper-based documentation hinders efficiency and delays batch releases. See how digital solutions can transform compliance.

• Driving Customer Profitability With Enterprise Platform, Pricing

  Explore how the solutions and approaches offered by CDS can help different research stakeholders conduct more cost-efficient clinical trials in the industry's pharmaceutical, biotech, and device sectors.

• 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.

• 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.

• Using Historical Performance To Optimize Your Coagulation Control

  Non-intrusive ultrasonic technology provides precise, bi-directional flow measurement without process downtime. By clamping onto the pipe exterior, these systems eliminate maintenance and pressure loss, offering a reliable, data-rich solution for complex water and wastewater monitoring environments.

• Offline eCOA: The Real-Time Monitoring Dilemma

  Balance the need for offline data safety with the necessity of real-time monitoring. Learn how to navigate new regulatory requirements for source devices while maintaining high patient compliance.