Healthcare

WHITE PAPERS AND CASE STUDIES

• Inline Checkweighing Of Packaged Products In Manufacturing

  Accurate inline checkweighing is vital for quality control. Learn how system design, software, and regulatory compliance work together to overcome high-speed production challenges.

• From Paper To Digital Study Management In Large Patient Registries

  Uncover how this sponsor was able to independently design and oversee its clinical study, minimizing external assistance, and easing the workload for their sites through mobile app accessibility.

• How Community Oncologists View CAR T-Cell Therapy Possibilities And Challenges

  Learn how a partner with innovative solutions aimed at overcoming the barriers that limit the real-world impact of CAR T-cell therapy can make these advanced therapies more accessible and affordable.

• What Is ICH GCP, And How Does It Impact Clinical Planning?

  The updated ICH GCP guideline modernizes clinical trial standards, aligning with today’s technologies to enhance participant safety, data integrity, and risk-based trial design.

• Commercializing Rare Disease Treatment With Near Real-Time Alerts

  How did Quest help a leading pharmaceutical company overcome the data latency challenges associated with traditional EHR when recruiting eligible patients for a rare blood disorder drug?

• How To Adopt CSA For Streamlined Computer System Validation

  Discover how the FDA’s Computer Software Assurance guidance modernizes validation by reducing compliance burdens and fostering innovation through a streamlined approach to system validation.

• Seamless Onshoring From China-Based CDMO

  Successfully mitigate geopolitical risk and maintain supply continuity. Learn how a large-scale manufacturing process was rapidly requalified in eight months to secure a clinical-stage biologic program.

• Optimizing EDC Strategy And Data Collection for a Rare Disease Trial

  Explore how Veristat created a forward-looking roadmap for EDC and CRFs integration for a small biotech sponsor, ensuring a future-ready data ecosystem without overcomplicating current operations.

• Mold In Cleanrooms: A Persistent Threat And The Case For Proactive Bio-Decontamination

  Learn how a comprehensive investigation and systems-level bio-decontamination strategy successfully eliminated persistent mold contamination in a vaccine manufacturing facility's high-risk area.

• Tackling Antimicrobial Resistance

  Learn how three companies collaborated to develop a new antibiotic to address the increasing development of antimicrobial resistance (AMR) that threatens the global health landscape.

• Best Practices For Sterilization Validation In Medical Device Manufacturing

  Sterilization validation ensures medical device safety by confirming sterility through rigorous testing, method selection, and regulatory compliance, using both established and emerging sterilization technologies.

• Taking Research In-House With CRIO: SciTech's Multi-Center Phase 1 Study

  Explore the success story of an early-stage clinical pharmaceutical company that effectively navigated funding constraints when conducting its Phase 1 study without a third-party CRO.