Healthcare

WHITE PAPERS AND CASE STUDIES

• Choosing An R&D Data Management Platform For Novel Antibody Therapeutics

  Uncover how this collaboration ensured the implementation of a robust electronic system that streamlined R&D operations, increased data integrity, and ultimately supported the development of novel antibody-based therapeutics.

• 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).

• Owen Mumford Slashes Audit Findings, CAPAs, And NCRs

  Gain insights into how Owen Mumford, a global medical device leader, enhanced their compliance and efficiency with software to reduce audit findings and improve quality management.

• Flexible Data Management For Growing Portfolio

  Explore strategic enhancements to a small biopharma's biometrics capabilities involving the deployment of 20 specialized professionals, which effectively bolstered the client’s organizational capacity.

• Automated Evidence Generation For Regulatory-Grade RWD

  Global regulatory agencies increasingly adopt Real-World Evidence, demanding higher data quality and automated AI-driven platforms to meet evolving standards and improve drug development pathways.

• Reframing Clinical Vendor Selection

  Explore a platform that enables seamless vendor selection as well as cross-functional collaboration with built-in templates and tailored question libraries that simplify proposal creation and review.

• Automated Validation And Centralized Data

  Discover how intelligent CPV, powered by automation and real-time analytics, is transforming manufacturing by driving quality, compliance, and innovation in a rapidly evolving regulatory landscape.

• Understanding And Implementing USP <665> For Single-Use Systems

  New expectations for single-use systems require structured risk assessment and extractables testing. As compliance deadlines near, practical guidance aligns science, knowledge, regulatory readiness.

• Verve Puts Digital-First Quality At The Heart Of Its QC Lab

  Learn how a biotech scaled faster by building a paperless lab, adopting cloud-based LIMS, and streamlining QA/QC processes to reduce errors, improve efficiency, and enable real-time collaboration.

• Democratize Batch Data Management For AAV Gene Therapies

  Explore a biotechnology company's process of choosing a data management solution that offered centralized batch data management, allowing the company to streamline its CMO data delivery process.

• 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.

• Sustainable Solutions For Medical Devices

  Explore how medical device companies aim to balance patient safety with environmental stability by offering bio-based UHMWPE, which reduces carbon footprints by up to 70%.