Sharepoint Solutions

WHITE PAPERS AND CASE STUDIES

• Gene Therapy For Mitochondrial Disease: A Guide To Emerging Regulation

  Learn how the FDA's expedited programs, along with the efforts of innovative companies, are paving the way for the development of effective gene therapies to address primary mitochondrial diseases.

• Newport News, VA Deploys 130,000 Mueller AMI Meters

  Eight years ago, Newport News started having discussions about moving away from reading their mechanical, manually read meters every other month to go to monthly billing. Knowing they did not have adequate staffing to handle that task, the department decided to outsource its meter reading responsibilities to a third party. 

• Annex 1: Sterile Fill/Finish For Early Phase Clinical Supplies

  Meeting stringent requirements for sterile fill/finish operations hinges on robust contamination control strategies, advanced isolator technology, and rigorous integrity testing to ensure patient safety.

• GSK And Medable Discuss The Next Phase Of DCTs

  GSK and Medable share the value of embedding DCTs into strategic goals to enhance trial accessibility, diversity, and efficiency.

• Streamlining Early-Phase Oncology Study Start-Up In Today's Clinical Environment

  Explore the significance of targeted therapies and adaptive trial designs that prioritize patient-specific characteristics.

• Development Of A Non-Standard Protein Therapeutic

  Discover how a tailored development approach transformed a complex therapeutic protein into a candidate ready for early-stage clinical trials.

• 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.

• A Digital Solution Embeds Quality Into Cellular Therapeutics Production

  Discover how Dendreon cut review and release time by nearly 50% while maintaining a 99% right-first-time rate, which boosts collaboration, visibility, and operational efficiency across teams.

• 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.

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  Pharma manufacturing embraces cutting-edge automation, yet outdated paper-based documentation hinders efficiency and delays batch releases.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

• 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.

• Patient-Focused Data Capture For Cancer Research

  In a field where innovation is constant and patient experience is pivotal, oncology demands eCOA solutions designed to balance scientific rigor with human realities.