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WHITE PAPERS AND CASE STUDIES

• 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.

• Patient Diversity: Identifying Challenges, Opportunities, And Best Practices

  By listening to the voice of patient diversity and implementing FDA guidance measures, learn how stakeholders can improve trust, engagement, data reliability, patient outcomes, and promote public health.

• Creating Sustainable Data In The Laboratory

  In a laboratory setting, data is everywhere. Learn in-depth about data challenges, the importance of data lifecycle management in laboratories, and the need for data sustainability.

• Choose How You Want To Pay: Flexibility In The Payment Process

  As the payment method landscape continues to evolve, retailers should have a strategy that takes into account current preferences and – to the extent possible – anticipates future changes.

• A Guide To Patient-Centric Digital Endpoints In Heart Failure Trials

  Unearth the ways actigraphy can objectively measure treatment effects on a variable that drives patient outcomes and prepare trials to better align with the FDA’s position on patient-centric drug development.

• 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.

• Mobile Advanced Therapies Facility

  Discover NIH's innovative solution to clinical-stage viral vector production: See how two mobile cGMP facilities deliver adaptability and compliance to Bethesda's National Institute of Health.

• American Academy Of Ophthalmology IRIS Registry Report

  The 2024 IRIS^® Registry Industry Report showcases the transformative power of real-world data (RWD) in ophthalmology.

• The Business Case For EHR eSource In Clinical Trials

  Examine how manual data collection challenges prompted the adoption of an eSource solution that streamlined data entry, saving time and costs, reducing errors, and accelerating a multicenter phase 2 trial.

• Simplify CAPA In 7 Steps

  Discover how to streamline corrective action/preventive action (CAPA) management in regulatory environments in 7 steps.

• Establishing Analytical Methods For mRNA-Based Therapies

  Here, we provide a detailed description of assays for sequence identification and LNP composition in mRNA-LNP products that support the development of safe and effective mRNA therapies.

• How AI Is Unlocking Healthcare Data To Transform Prostate Cancer Treatment

  As the global reliance on algorithms and artificial intelligence (AI) continues to grow, the importance of data quality and completeness has become a critical concern.