Sharepoint Solutions

WHITE PAPERS AND CASE STUDIES

• Navigating The Complexities Of CGTs With Regulatory And CMC Expertise

  Review the submission process and CMC expertise which helped a biopharmaceutical company targeting a rare-disease tumor type avoid a clinical hold and advance to phase 1 clinical trials.

• A Race Against Time: Startup Partners With Donatelle For Novel Class III Device

  In a race against time, a startup takes advantage of Donatelle’s pure medical expertise and vertical integration for the development of a novel Class III device.

• Streamlining Single-Use Assemblies In The Bulk-Fill Step Of Downstream Processing

  Single-use (SU) systems and components are growing in demand as they offer minimal contamination risk. Review a standardized SU assembly for bulk-fill processing that aims to improve efficiency.

• Accelerating Rare Disease Trials With Biometrics Services

  Find out how one therapeutics company regained control over its data assets while increasing its ability to conduct comprehensive oversight and review activities across all data sources for faster decision-making and analysis time.

• RNA: The Next Era In Therapeutic Development

  Review the unique set of challenges for RNA production that must be considered and solved to reach their full therapeutic potential.

• TargetCancer Foundation Successfully Engages And Empowers Rare Cancer Patients

  Delve into how the TargetCancer Foundation implemented a remote consent function in their TCF-001 TRACK study with an objective to determine if rare tumors can benefit from matched molecular therapy.

• Women-Centric Approach To Clinical Trials

  Women are demanding more power, information, and control when it comes to their health. Learn how women now have a stronger voice when it comes to clinical research for treatments that impact their care.

• How To Run Successful Clinical Trials In Japan

  Read about why there is no longer any excuse not to include Japan as an integral part of any global clinical-development program for either pharmaceuticals or medical devices. 

• Mobile Application Considerations For Clinical Trials And Beyond

  Delve into fundamental definitions, navigate through the regulatory landscape, and examine common applications of mobile apps in research.

• Dwell Volume And Extra-Column Volume: What Are They And How Do They Impact Method Transfer?

  Understand how system factors like dwell volume and extra-column volume contribute to method performance across labs and how this knowledge can increase the success of method transfer.

• Supporting A Sponsor From SPA Rejection To BLA Submission

  Learn how the clinical trial design and the statistical foundation of the special protocol assessment (SPA), which helped drive to regulatory agreement, was transformed in this case study.

• Choose How You Want To Pay: Flexibility In The Payment Process

  As the payment method landscape continues to evolve, retailers should have a strategy that takes into account current preferences and – to the extent possible – anticipates future changes.