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WHITE PAPERS AND CASE STUDIES

• Breaking Through Barriers With Integrated Trial Optimization

  In today’s complex clinical trial environment, optimizing trial design requires a multidimensional strategy that balances scientific rigor with real-world constraints.

• The Role Of The Technical Transfer Executive Sponsor

  Explore the importance of understanding a CDMO’s flexibility and culture, models and scale of equipment, technical capabilities, regulatory support, quality system, and executive sponsorship model.

• Regulatory Considerations For Excipients Used In Lipid Nanoparticles

  Review the regulatory classification of LNPs, liposomes, and novel excipients as well as specific requirements outlined in regulatory guidance documents and strategies to navigate emerging challenges.

• Gene And Cell Therapy: Planning For Manufacturing Success Early

  As gene therapy organizations are asked to balance the need for rapid clinical progression and stringent quality expectations, explore how to optimize plasmid production and reach patients with efficiency.

• Achieve Operational Excellence Through Planning And Scheduling Optimization

  How optimized plans and schedules can dramatically increase business value in service, manufacturing, and asset-intensive industries.

• 7 Tips To Improve OT Cybersecurity For Life Sciences

  Leverage the insights of cybersecurity specialists and industry experts to gain a broader context for more informed decision-making regarding actions and next steps to improve OT cybersecurity.

• How eSource Reduced Benchmark's Protocol Deviations By Almost 40%

  Explore how a leading vaccine site network selected CRIO to help address the challenges with it's use of paper charts in collecting source data.

• Driving Digital Excellence In Life Sciences

  The life sciences industry is rapidly evolving through digital transformation and agility. Discover why embracing modern technologies is essential to thrive in today’s competitive landscape.

• 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.

• From CLD To CDMO: Demonstrating A Successful Cell Line Technology Transfer

  Explore critical considerations for biopharmaceutical developers and CDMOs during technology transfer as well as a successful transfer and scale-up of a cell line from a CLD platform to a global CDMO.

• Relieving The Strain Of Publishing During Regulatory Registration

  Go inside how an expertly handled NDA submission for a biopharma company ensured timely FDA approval despite challenges.

• Best Practices For Internal Quality Audits In Life Sciences

  Discover why internal quality audits are vital in the life sciences sector to ensure regulatory compliance, mitigate risks, and maintain high standards of product quality and patient safety amidst evolving challenges.