Sharepoint Solutions

WHITE PAPERS AND CASE STUDIES

• Accelerating SCTU’s Digital Transformation And Supporting Its COVID-19 Studies With Unified Platform

  Southampton Clinical Trials Unit was using largely manual and paper-based processes to run its studies that required multiple touchpoints and logins. As the IT support provided by the University was not specialized in clinical trials software, the SCTU team decided to move to a Software as a Service (SaaS) model to help streamline their clinical trials on a unified platform.

• Understanding The RTF Letter

  The development of new treatments, both drugs and biologics, is a long and arduous process, which can take many years. There are two major obstacles to getting approval and market authorization: the Complete Response Letter and the Refuse-To-File (RTF) letter. Explore the RTF process and how an RTF letter can be avoided.

   
• Performance Of Protein A Resins For Different mAbs

  Review a Protein A resin solution assisting biotech companies who are working with and removing impurities from a wide variety of antibodies.

• Case Study: Recruiting Pediatric Ultra-Rare Disease Patients

  Explore how Rezolute was able to overcome challenges while recruiting pediatric patients for a Congenital Hyperinsulinism (HI) clinical trial using a streamlined, single-source tool.

• Improving An Abandoned Cancer Medication Using Innovative ASD Technology

  Review the case study and learn how KinetiSol Solid Dispersion lowered patients' pill burdens and demonstrated an improved therapeutic response for Galeterone.

• X-Ray Inspection Of Frozen Burgers

  Meat and convenience products processor installs x-ray inspection solution to satisfy increased customer requirements and demands in terms of quality assurance and production capacity.

• 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.

• 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.

• De-Risking Preclinical Candidates With Predictive Immunotoxicology

  From target engagement and mechanism of action to efficacy and prediction of adverse immune reactions, immunology assays deliver data that reduce your risk of failing later.

• 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.

• 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.

• Method Optimization: Assay Development Following Compendial Methods

  There was a short time frame of only 7 weeks to complete assay optimization and conduct pre-validation studies within the confines of USP<621>.