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WHITE PAPERS AND CASE STUDIES

• Elevating Diverse Patient Voices To Inspire Clinical Trial Participation

  Explore the innovative approach taken during this clinical trial partnership to address the underrepresentation of minority communities in clinical trials through digital storytelling.

• AI Predictive Maintenance Prevents Batch Loss And Production Shutdown

  AI-powered predictive maintenance with wireless vibration sensors prevented costly batch loss and production shutdowns in pharma manufacturing by detecting and fixing equipment issues before failures occurred.

• Implementation of the New European Health Technology Assessment Regulation (HTAR)

  The European Health Technology Assessment Regulation (HTAR) requires joint clinical assessments for certain therapies starting 2025, impacting market access preparation for companies in the EU.

• Immunohistochemistry In Precision Medicine: From Biomarker To Clinical Trial Assay

  From preclinical validation to clinical implementation, immunohistochemistry (IHC) is essential in understanding target biology and ensuring drug safety and efficacy.

• Extra-Terrestrial Connections: Enabling Optical Mesh Networks In Orbit

  Optical filter implementation into orbital mesh networks must consider how price, performance, and delivery timeline can be optimized together to align with specific customer needs.

• Bringing A Device From Concept To Market

  Within three years, see how this company was able to achieve FDA approval and CE Marking, facilitating its entry into the U.S. and EU markets.

• Impact Of Glycosylation On The Effector Functions Of Monoclonal Antibodies

  In an example using rituximab and its biosimilars, explore the significance of minor differences of glycosylation in antibodies and its impact on their properties and functionality.

• Strategies For Post-Approval Lifecycle Management And Local PV

  If you are unsure of how to navigate your post-approval regulatory journey, an experienced regulatory services partner can provide support to help you identify and achieve post-approval goals.

• 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.

• How Advanced Biological Technologies Overcome Complex Wastewater Treatment Challenges In The Oil And Gas Sector

  This white paper explores how advanced biological technologies — including MBBR, IFAS, SBR, and MBR systems — are transforming wastewater management in this sector.

• Boosting CMC Regulatory Efficiency In Gene Therapy

  Ensure your business stays ahead in today’s complex regulatory environment by implementing robust regulatory affairs strategies that streamline compliance and product approvals.

• Everest Group Life Sciences eCOA Peak Matrix Assessment 2025

  Discover how digital platforms are revolutionizing clinical trials by improving data quality and patient engagement in this comprehensive market assessment.