Sharepoint Solutions

WHITE PAPERS AND CASE STUDIES

• 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.

• Streamline Recruitment With Confidence

  Transform your clinical trial recruitment with a service that delivers faster, more cost-effective enrollment, particularly for hard-to-reach populations.

• 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.

• Contamination Control Of Particulate And Shuttle Blow-Fill-Seal Compliance

  Does shuttle blow-fill-seal truly meet Annex 1’s stricter contamination standards? New particle burden data challenges industry assumptions and reveals what manufacturers need to know.

• 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.

• PEG In LNP Formulations: Addressing Challenges And Seeking Solutions

  Polyethylene glycol and similar variants have driven innovative research for therapies. However, the continued use of PEG poses significant drawbacks.

• A Risk-Based Approach To Plasmid DNA And mRNA Process Development

  Balancing robust analytics and clinical readiness is key for early-phase pDNA and mRNA therapeutics amid structural complexity and regulatory challenges.

• AOC GMP Manufacture For A FIH Study

  Successful development of AOCs for FIH studies requires robust GMP processes and efficient scale-up. A key step is careful management of a multi-day conjugation process with vital in-process checks.

• 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.

• How To Avoid Sticking And Picking In The Tableting Industry

  Review strategies to mitigate sticking and picking risks in the tablet industry, and learn how you can foster improved tablet production processes, ensuring higher quality and consistency.

• Strategic Pre-IND Consulting For Gene Therapy In Rare Leukemia

  Learn about the collaborative efforts of an innovative biotech startup and Ergomed Consulting to overcome challenges in the pre-IND phase for a novel gene therapy targeting a rare form of leukemia.

• 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.