Healthcare

WHITE PAPERS AND CASE STUDIES

• Expert Consulting And MRCT Strategy Rescues Oncology Program

  Uncover how this strategic approach yielded significant outcomes, including uncovering missing data through IB review, streamlining dosing timelines, and achieving successful recruitment milestones.

• BioIVT Collaborates With IDBS To Deploy IDBS E-WorkBook And Reduce Study Cycle Times

  Learn about a collaboration that has enabled BioIVT to enhance efficiency and responsiveness to its biopharmaceutical clients.

• 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).

• Aegea Creates Brazil's Largest 3D Digital Sanitation Map As Part Of Their Intelligent Infrastructure Program

  In this case study, learn about a highly interactive 3D map representing over 1,000 sanitation facilities in a virtual reality environment which optimizes performance, service availability, and reliability.

• 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.

• Could RFID-Based Unit-Level Traceability Be Key To Operational Excellence?

  Radiofrequency identification (RFID)-based unit-level tracking solutions for prefilled syringes are poised to help pharma manufacturers address key risks and costly bottlenecks related to the fill-finish process.

• CHO Cell Lines For Recombinant Protein Production

  Discover how new strategies in CHO cell line development are driving innovation and transforming the future of biologics manufacturing, from enhanced productivity to improved therapeutic quality.

• Digital Biomanufacturing, Now: From Digital Dreamer To Digital Doer

  Discover how digital biomanufacturing is revolutionizing drug production by exploring strategies for integrating digital technologies to enhance efficiency and innovation in bioprocessing workflows.

• 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.

• The Need For Direct RF In An Evolving Defense Environment

  Discover why it is important to move toward direct RF, explore its capabilities and applications, and see how innovative products can help make the DoD’s vision a reality.

• Navigating Regulations And Risk Management For Ophthalmic Medical Devices

  Ophthalmic medical device safety relies on regulatory compliance, rigorous risk management, and thorough testing, ensuring quality, patient safety, and effective vision care worldwide.

• Pioneering Cancer Research Meets Unparalleled Veeva Vault Integration

  A biotech company revolutionizing cancer treatment faced delays due to a complex, error-prone document review process. Discover how integrating an innovative strategy transformed their workflow.