Sharepoint Solutions

WHITE PAPERS AND CASE STUDIES

• Microbial Challenge In-Use Studies

  Learn more about how a partner with expertise can help you navigate the complex landscape of microbial challenge in-use studies and ensure the highest standards of patient care.

• Navigating The Complexities Of CGTs With Regulatory And CMC Expertise

  Review the submission process and CMC expertise which helped a biopharmaceutical company targeting a rare-disease tumor type avoid a clinical hold and advance to phase 1 clinical trials.

• The New Industry Migration Framework For FSP

  Review why a functional service provider should be on the top of a sponsor’s list when it comes to choosing a specialized eClinical data management provider for its next study.

• The Key To Accelerating RNA-LNP Drug Development

  Learn about the drug development hurdles that must be overcome to deliver on the promise of mRNA.

• CDMO Accelerates Contract Manufacturing With Electronic Batch Records

  A prominent CDMO sought a specialized software solution to streamline and accelerate its manufacturing processes, enabling the efficient production of complex, customized products in record time.

• 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.

• 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.

• 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.

• 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.

• The Role Of The Technical Transfer Executive Sponsor

  Explore the importance of understanding a CDMO’s flexibility and culture, models and scale of equipment, technical capabilities, regulatory support, quality system, and executive sponsorship model.

• Top-Tier University Stays Compliant With HRPP Assessment

  Discover how one university was able to identify and resolve programmatic gaps in compliance with federal regulations and revitalize its Human Research Protection Program.

• Flexible Integrations To Reduce Risks And Increase Efficiencies

  Learn how a trial team kept the blind of central lab samples and patient treatment across a Phase III and extension trial, whilst optimizing the supply chain.