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WHITE PAPERS AND CASE STUDIES

• Quality By Design: Better Data Using Participant Insights

  While clinical trials will always encounter challenges in driving quality experiences and data, there is one approach that’s backed by regulatory agencies and proven to lead to better outcomes.

• Methods For Determining Equipment Capability Of Freeze-Dryers

  Observe two experimental methods for determining choked flow: the minimum controllable pressure method and the choke point method.

• Delivering Water Biosecurity At Palma Aquarium Spain

  Learn how Palma Aquarium safeguards its delicate marine ecosystem with Atlantium’s innovative HOD UV technology, preventing disease outbreaks and protecting the environment.

• Forge Boosts Efficiency And Compliance During External Collaboration

  Streamlined collaboration and unified quality systems are helping CDMOs cut review times. Discover how connected workflows improve compliance and efficiency for faster delivery of life-changing treatments.

• 5 Steps To Design A Microbiological Performance Qualification For Facilities

  Explore five steps to design an EMPQ for sterile manufacturing: classification, protocol drafting, cleaning evaluation, disinfectant efficacy testing, and continuous improvement.

• Analytics–Powered Approach To Patient Recruitment Strategy

  In a Phase 3 psychiatry trial, a pharmaceutical company partnered with Signant to revolutionize patient recruitment through data-driven site selection using PureSignal Analytics.

• Revolutionizing Pharmaceutical Quality Control

  Learn about a South Korean pharmaceutical company's QC laboratory and how the operation of its chromatography systems has been transformed by implementing a real-time monitoring system.

• Overcoming The Top 3 Challenges In Setting Up And Managing Clinical Trials

  Navigating the intricacies of clinical trials demands adept handling of document management, regulatory compliance, and financial forecasting. Learn key strategies for overcoming these hurdles.

• Development And Optimization Of Suspension-Adapted 293T Cell Line

  Learn how an adapted cell line can reduce costs and improve scalability in the production of lentiviral vectors for CGTs and examine its potential to produce GMP-grade lentiviral vectors.

• Breaking Barriers In Malaria Prevention With A Mobile Cleanroom

  The delivery of this mobile cGMP cleanroom facility to ACT showcases Germfree’s commitment to providing innovative solutions that meet clients' unique needs and contribute to advancing healthcare.

• Bringing Clinical Testing To New Heights In New Jersey

  Explore how clinical testing was transformed with a pioneering BSL-2 mobile laboratory on a Sprinter Van platform to enhance safety and portability for advanced biosafety requirements.

• 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.