Sharepoint Solutions

WHITE PAPERS AND CASE STUDIES

• Raise The Bar: Setting New Standards For The eCOA Industry

  A paradigm shift may be necessary to increase the adoption of Electronic Clinical Outcome Assessments (eCOA) in clinical research. Explore six pivotal areas where eCOA standards can be improved.

• Authentic Engagement: Reaching Underserved Lupus Patients

  By partnering with the ICLF, see how we were able to gain access to and build trust with influential community leaders and advocates within the African American communities located near study sites.

• Enabling Micron Level Mounting Accuracy

  Explore different lens assembly techniques and how Exact Placement assembly technology addresses the requirements for the tightest possible tolerances.

• 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.

• Stopper Migration In Frozen Pre-Filled Syringes

  Review a semi-automated method for dynamically assessing plunger migration under controlled variations in temperature and pressure, utilizing computer vision tools.

• Response To FDA Black Box Warning

  The FDA has launched an investigation into the risk of T-cell malignancies following CAR-T cell immunotherapies. Review the key points of this announcement concerning the CGT research community.

• Overcoming Known Pharmacological Effects

  Uncover how our team was able to address the challenges of evaluating treatments that reduce food consumption and cause body weight loss while ensuring animal health and study integrity.

• 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.

• 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.

• The EMR Interoperability Dream Vs. Clinical Research Reality

  Seamless Electronic Medical Record access promises accelerated trials and regulatory-grade evidence, but incomplete, unstructured data requires hybrid strategies using AI and human oversight to bridge gaps.

• 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.

• NuGenesis 9.3 – What's New

  Explore the latest features of a user-centric lab management system that comprises data, workflow, and sample management capabilities to support the entire product lifecycle.