High-Volume Scanners

WHITE PAPERS AND CASE STUDIES

• Breaking Down Operational And Financial Complexity In Clinical Trials

  Consider how factors like hybrid visits, enrollment patterns, and variable procedure volumes shape both the cadence and magnitude of site payments, supplier activity, and patient-related expenses.

• Transforming Environmental Monitoring And Sample Management

  Discover how applying an OpEx framework to environmental monitoring and sample management can optimize workflows, improve resource utilization, and deliver measurable annual cost savings.

• 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.

• Building A High-Quality IND From Scratch With Strategic Gap Analysis

  A biotech sponsor lacking in-house regulatory expertise engaged a partner to obtain strategic regulatory review, medical writing, project management, and electronic publishing (eCTD).

• Scale Up Strategy For Oncolytic HSV-1 Vector Manufacturing

  Discover how a novel, large-scale production method for herpes simplex virus type-1 vectors has the potential to accelerate the progress of gene therapy and bring it closer to widespread application.

• If You Can't Win The Game, Change It

  Explore how eData sharing is used in the biopharma market, enabling standardized, collaborative supply chains that reduce risks and enhance visibility while improving capacity planning.

• 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.

• Case Study: Groundwater DWTP (NJ) – DEXSORB Full-Scale

  Cyclopure was invited to replace ion exchange resin to remove PFAS from groundwater at a groundwater pump station, located in NJ. The decision to replace IXR was due to poor PFAS removal caused by manganese fouling.

• Compliance Auditing: Diving Into Common Critical Findings

  Review critical findings in compliance audits, highlighting frequent issues, their impact on operations, and steps companies can take to improve regulatory compliance.

• Using Virtual Study Coordinators For EDC Entry And Query Resolution To Speed Up Data Access And Cleaning

  The piece showcases how the effective use of CRIO can significantly enhance site performance, supporting recruitment and diversity objectives for sponsors.

• Accelerating Cold Chain Expansion: Responding To COVID-19 Challenges

  Review how leveraging cross-functional teamwork helped complete a cold chain infrastructure expansion in a fraction of the expected timeline, ensuring the production of essential COVID-19 therapeutics.

• Symmetry Surgical Uses Software To Enhance Quality

  Symmetry Surgical enhances operations and quality management using software to improve efficiency, compliance, and data-driven decisions while producing over 2 million surgical devices annually.