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WHITE PAPERS AND CASE STUDIES

• ICH E6(R3) In Effect: Transforming Quality Management For CGT Trials

  Discover how the updated ICH E6(R3) guideline supports the speed and complexity of CGT manufacturing, enabling flexible, risk‑based decisions and quality systems built to scale therapies safely.

• Viral Disinfectant Efficacy Studies: Key Guiding Factors And Design Elements

  Achieving compliance and safety through Disinfectant Efficacy Studies (DES) is about adhering to regulations and committing to high standards of safety and quality of manufacturing operations.

• Rethinking Clinical Operations: A Smarter, Faster Playbook For Trial Success

  The CRO-sponsor partnership is now strategic, addressing communication gaps and fragmented systems to improve efficiency. Joint governance, real-time tracking, and unified technology accelerate complex trial execution.

• Boosting CMC Regulatory Efficiency In Gene Therapy

  Ensure your business stays ahead in today’s complex regulatory environment by implementing robust regulatory affairs strategies that streamline compliance and product approvals.

• Future-Proofing Life Sciences Manufacturing: 2025 CDMO Trends

  Review contract manufacturing's evolution, driven by technological advancements and regulatory changes, and how CMOs and CDMOs are navigating opportunities and challenges.

• Long-Term Cost Of Pump Oversizing

  Pump oversizing drives hidden costs through energy waste, reduced reliability, and increased wear, making proper sizing and modern controls critical for long-term efficiency and performance.

• Patented Process For Intermediates Useful For Etrasimod Arginine

  Explore how rethinking the synthetic strategy for Etrasimod can overcome the limitations of legacy routes, enabling more efficient chirality control, improved scalability, and more practical industrial API production.

• 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.

• Trial Rescue And Reconnaissance

  Explore a strategic partnership that resulted in a rescue plan for a Phase III oncology trial that was facing high site decline rates.

• BioIVT Collaborates With IDBS To Deploy IDBS E-WorkBook And Reduce Study Cycle Times

  Learn about a collaboration that has enabled BioIVT to enhance efficiency and responsiveness to its biopharmaceutical clients.

• 3-Week Database Builds That Withstood FDA Review

  Learn how a lean clinical team deployed global, regulator-ready databases in just three weeks to secure immediate Phase 3 entry and transform reproductive health research.

• 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.