Sharepoint Solutions

WHITE PAPERS AND CASE STUDIES

• Regulatory Considerations For Excipients Used In Lipid Nanoparticles

  Review the regulatory classification of LNPs, liposomes, and novel excipients as well as specific requirements outlined in regulatory guidance documents and strategies to navigate emerging challenges.

• An Introduction To Passive Radar Systems

  Dive into the concept and operating principles of passive radar systems, review the basics of bistatic radars, and introduce the concept of emitters of opportunity (EoO) and their ideal qualities.

• 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.

• Rescuing A Global Full-Service Phase III Trial For A Late-Stage Oncology Biotech

  This case underscores the expertise employed in a comprehensive strategy and set of services that were used to salvage a Phase III clinical trial for ovarian cancer and ensure its timely completion.

• 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.

• Earning RMAT Designation - What Developers Need To Know

  Explore a high-level overview of the Regenerative Medicine Advanced Therapy designation and how to ensure success and accelerate advanced therapy products toward commercialization.

• 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.

• 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.

• CRO Leverages Partnership With Integrated Central IBC To Initiate Sites

  Discover how a CRO was able to reduce study startup timelines and deliver trial results to the sponsor quicker than expected.

• 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.

• Are You Leveraging All Of Your Clinical Data?

  To develop and execute a successful clinical strategy, trial sponsors must be able to rapidly acquire detailed data insights. Learn how you can better utilize your trial data and achieve greater insights.

• Supporting A Company In Manufacturing The RSM For Treating A Rare Tumour

  A clinical-stage oncology company needed a partner to manufacture the RSM. Examine how an optimized RSM manufacturing process helped deliver safe, effective treatment on an accelerated timeline.