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.

• Navigating Digital Transformation For Pharmaceutical CDMOs

  Discover how CDMOs can modernize operations, safeguard data integrity, and improve audit readiness with practical strategies for connecting systems and reducing validation burdens.

• The Impact Of Artificial Intelligence On CQV

  AI is revolutionizing CQV in life sciences by automating documentation, enabling real-time monitoring, and driving predictive quality to boost efficiency and compliance across validation processes.

• 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  Pharma manufacturing embraces cutting-edge automation, yet outdated paper-based documentation hinders efficiency and delays batch releases.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.

• AOC GMP Manufacture For A FIH Study

  Successful development of AOCs for FIH studies requires robust GMP processes and efficient scale-up. A key step is careful management of a multi-day conjugation process with vital in-process checks.

• Accelerating SARS-CoV-2 Immunotherapy Speed To Clinic

  A clinical-stage biotherapeutics company developing a COVID-19 immunotherapy searched for a solution to the difficulties it faced in scaling up its manufacturing operations due to limited resources.

• Rescuing A Global Program For NDA Success

  Explore the collaboration that enabled FDA approval of a novel chronic-condition therapy, rescued a high-risk program, and demonstrated a unified “one-team” approach by reworking the sponsor's SAP.

• Improving Patient Health and Safety: Quality and Analytical Scientist

  Explore how an analytical scientist enhanced quality and compliance for a pharmaceutical company by managing complex analytical testing and vendor interactions.

• 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. 

• Unveiling The Critical Role of Sleep In Clinical Studies

  Explore the critical role of sleep in clinical trials and its impact on health outcomes, emphasizing the need to address sleep disturbances for more effective and reliable research.

• Metropolitan Sewer District Of Greater Cincinnati

  The Lower Mill Creek Partial Remedy (LMCPR) in Hamilton County, Ohio, is a large, complex effort to remove about 1.78 billion gallons of combined sewer overflows (CSOs) annually from the Mill Creek, an Ohio River tributary. When complete, LMCPR will improve water quality and serve as a catalyst to improve local neighborhoods.

• The Evolution Of SDV, SDR, And RBQM In Clinical Trial Data Quality

  Explore the inefficiency of complete SDV and how the adoption of technologies like centralized monitoring, remote SDR, and targeted SDV can enhance data integrity and cost-effectiveness.