Sharepoint Solutions

WHITE PAPERS AND CASE STUDIES

• What Does The New FDA DHT Guidance Mean?

  In December 2023, the FDA released the final version of its digital health technologies guidance, outlining the facilitated use of sensor-based DHTs and wearables in clinical investigations.

• The Role Of A Consulting Firm In The IND Process

  Navigate the complex IND process with expert guidance and discover how early FDA engagement can accelerate your path to clinical trials.

• Project Orbis Drug Registration 2025

  Project Orbis helps streamline the review and approval of oncology medicinal products through international regulatory collaboration. Learn how this framework can accelerate your regulatory strategy.

• eSource Purpose Is Not Just To Complete The EDC

  Central eSource transforms data capture from a passive, back-end chore into an active, real-time quality and compliance engine—delivering benefits that extend beyond faster EDC feeds and reduced SDV.

• Advancing In Silico Predictions In Early Drug Discovery

  Examine a high-throughput approach that streamlines LogD measurements, offering faster and more accurate insight into compound lipophilicity to support better decision-making in early drug discovery.

• AMERICAN Ductile Iron Pipe Used In Northwest Missouri's New Regional Water Authority

  What began as a lofty idea will soon become a reality as a new regional water authority is established in Northwest Missouri. The Great Northwest Wholesale Water Commission will supply water to more than 11,000 people in rural areas of Cameron and Maysville, Missouri, with the capability to expand to other communities in the future.

• 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.

• Quantitation Of Monoclonal Antibodies In Serum

  Monoclonal antibodies (mAbs) are a rapidly growing group of targeted therapeutics. Gain insight into the importance of optimized bioanalytical assay platforms for mAb development.

• Flexible Integrations To Reduce Risks And Increase Efficiencies

  Learn how a trial team kept the blind of central lab samples and patient treatment across a Phase III and extension trial, whilst optimizing the supply chain.

• Digitalizing Batch Records In Pharmaceutical Production

  Pharma manufacturing embraces cutting-edge automation, yet outdated paper-based documentation hinders efficiency and delays batch releases. See how digital solutions can transform compliance.

• Rescuing Data Integrity: A Swift Transition And Quality Transformation

  Uncover how this collaboration supported timely progress toward key study milestones, enabling smoother execution and more dependable output across data management and statistical activities.

• Aseptic Filling Solution Enhances Sterility Assurance for Pharma Manufacturer

  Emergent BioSolutions upgraded its Winnipeg site with the Cytiva SA25 aseptic filling workcell to improve sterility assurance, product flexibility, and regulatory compliance for CGT manufacturing.