Sharepoint Solutions

WHITE PAPERS AND CASE STUDIES

• The Effect Of Conventional Cooling Versus Controlled Ice Nucleation On Primary Drying Time

  See how controlled ice nucleation shortens lyophilization cycles, supports higher drying temperatures, and reduces complexity for amorphous and mixed formulations without sacrificing quality.

• Optimal Syringe Carton Design To Meet Drug Manufacturers' Needs

  Learn about the advantages of an optimal packaging design and the resulting benefits of its implementation to the overall process.

• Advancing Dose Escalation Strategies With Bayesian Modeling

  A CRO was engaged to help a biotechnology sponsor develop a novel oncology therapy design and execute a multicenter, open-label Phase 1/2 dose escalation and expansion study in advanced solid tumors.

• Outgrowing Excel: Implementing RTSM Software In A Live Phase I Trial

  Moving from manual spreadsheets to RTSM mid-study requires precision. Learn how clinical teams maintain trial momentum while executing protocol changes without delays.

• Avoiding The Pitfalls Of PQR

  Explore the fundamentals of Product Quality Reviews (PQRs), common challenges manufacturers face, strategies for streamlining PQRs, and solutions that aim to unlock the potential of a "real-time PQR."

• Organizational Assessment For A Large MedTech Company

  Explore an organizational assessment run for a medical technology company specializing in tissue repair and regeneration, and the actionable recommendations provided to facilitate future growth.

• 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.

• Removing Translation Bottlenecks With AI

  See how an AI-enabled approach eliminated the manual, time-consuming translation bottlenecks that often delay clinical trial launches.

• Innovative ASD Technology Improves Abandoned Cancer Medication

  Review this case to learn how one solid dispersion technology lowered patients' pill burdens and demonstrated an improved therapeutic response for Galeterone.

• Enabling CDMOs To Focus On Core Priorities

  Explore innovative solutions for CDMO's striving to remain competitive as the biopharmaceutical market grows and evolves.

• Choosing The Right Platform: A Comparison For Regulated Industries

  Regulated industries depend on tightly controlled review workflows, yet common tools rarely meet those demands. Explore how purpose‑built solutions strengthen compliance and help streamline timelines.

• 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.