Sharepoint Solutions

WHITE PAPERS AND CASE STUDIES

• Biostatistics And Programming — More Than Just Clinical Trials

  See how our biostatisticians and programmers successfully ingested, cleaned, and analyzed the data, ultimately providing a small biotech company with several interesting and actionable measures.

• Container Selection For A Highly Sensitive Drug Product: A Success Story

  Learn about the importance of selecting the right container for sensitive drug products and how close collaboration is crucial for avoiding commercialization delays and safety risks to patients.

• Design Testing Strategies To Develop A Drug-Device Combination Product

  Leveraging the expertise and experience of a trusted partner can reduce risk and accelerate the time to market for drug-device combination products by creating an optimal Validation Master Plan.

• Advancing Rare Disease Clinical Trials With Point-Of-Need Eye Assessments

  During the COVID-19 pandemic, Applied Genetic Technologies Corporation (AGTC) faced significant hurdles in enrolling participants due to travel restrictions and site limitations.

• Alzheimer's Study Involving Home Infusions Exceeds Expectations

  Gain insight from this Phase 3 global clinical trial focused on pre-clinical Alzheimer’s Disease where adult patients received one-hour intravenous infusions every month for 4.5 years.

• The Benefits Of End-To-End Formulation And Fill/Finish Of Biologics

  Proper formulation development has a huge impact on whether a technology transfer to clinical phase fill/finish is successful. Review the challenges of transitioning a promising drug candidate.

• Inspecting On The Edge — Understanding Punch Tip Wear

  Why is a horizontal optical comparator highly recommended for tablet manufacturers as a measuring tool for punch tip inspection, and what strategies can be used to detect, reduce, and prevent tip wear?

• Project Orbis Drug Registration 2025

  Project Orbis helps streamline the review and approval of oncology medicinal products through international regulatory collaboration. Learn how this framework can accelerate your regulatory strategy.

• Achieving Faster Timelines And Cost Savings Through Digital Validation

  Examine how the Project Ready program was leveraged to streamline validation processes for a CDMO, resulting in a 25% reduction in budget and faster project completion.

• Benefits Of Implementing EDC & Medical Coding With RTSM

  Discover what happened when the Fountayn Platform, including RTSM, was used to support a client’s two-year, Phase III study seeking a cure for multiple sclerosis.

• Relieving The Strain Of Publishing During Regulatory Registration

  Go inside how an expertly handled NDA submission for a biopharma company ensured timely FDA approval despite challenges.

• 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.