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WHITE PAPERS AND CASE STUDIES

• From Phase I In Australia To A Global Phase III

  With some help, see how one California-based biotech company was able to get its patients on treatment by the end of the fiscal year and identify additional opportunities to streamline processes and leverage document/process standards.

• Designing, Selecting, And Developing Bioconjugates For Clinical Success

  Accelerate the development of complex bioconjugates to unlock new possibilities for targeted therapies and advance the next generation of precision medicine.

• Simplify CAPA In 7 Steps

  Discover how to streamline corrective action/preventive action (CAPA) management in regulatory environments in 7 steps.

• Optimized Fill And Finish To Limit DMSO's Negative Impact On T Cells

  In order to improve the existing cryopreservation paradigm, operators must consider fill/finish and cryopreservation techniques that streamline processing steps and minimize cells’ exposure to DMSO.

• 8 Ways To Achieve Higher ROI In Quality

  Is your company still using outdated methods for its QMS? It's time to evolve. Uncover how an integrated QMS can streamline operations, enhance compliance, and support your company's growth.

• 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.

• RO Protection At Trimble County Power Station, US

  Read about how the installation of the HOD UV technology has been a viable non-chemical means for biological control and membrane protection for Trimble County.

• 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.

• A Review Of The Changing Trends And Use Of eCOA In Clinical Trials

  Delve into how electronic clinical outcome assessments are being transformed through new technologies, the maturation of digital organizations, and increased endorsement from regulatory bodies.

• Optimal COA Measurement Strategy In Modern Oncology Trials: Insights

  Explore the challenges and opportunities in implementing patient-reported outcome measures (PROMs) in oncology trials. This article discusses the recent FDA draft guidance, emphasizing how more targeted PROM strategies could lead to better medication labeling and patient care in cancer treatment.

• Support Digital Transformation And Enable Collaboration Between Teams

  Discover the solution PharmaEssentia, a Taiwanese pharmaceutical company, chose to help teams capture, structure, and interrogate data from a single source, making their collaboration more efficient.

• 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.