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WHITE PAPERS AND CASE STUDIES

• Top Biopharma Enhances Regulatory Efficiency

  Learn how this biopharma company was able to assemble project teams focused on implementing real-time document transfer for central IRB documentation and communications, significantly reducing errors and improving data management.

• Navigating The Privacy Tightrope For CTIS

  Examine the challenges, potential risks, recommended best practices, and future trends related to anonymizing personal data for Clinical Trials Information System submissions.

• Epigenetics Application Guide: RNA Modifications

  Learn about the rapidly evolving field of RNA modifications, including innovative techniques like miCLIP and RIP for mapping chemical modifications and understanding RNA’s role in cellular processes.

• Removing Chaos In 3 Steps: A Guide To Planning TMF Migrations

  Knowledge and planning are the keys to successful trial master file migrations. Utilize this guide when navigating the most important part of any TMF migration: project scoping and planning.

• Revolutionizing Particle Characterization With Image Analysis And ML

  The biopharmaceutical industry is increasingly employing micro-flow imaging for particle characterization, owing to the superior insights it can afford into product quality and process controls.

• 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.

• What Does Pharma 4.0 Mean To Cell and Gene Therapy Drug Manufacturers?

  Explore the benefits of Pharma 4.0 for CGT companies along with the challenges they may face when implementing the convergence of people, systems, and data within a singular network.

• Improving API Solubility

  Ensuring adequate solubility is crucial for small molecule drugs' effectiveness. Find out how poor solubility remains a significant challenge, potentially hindering medications from reaching the market.

• Pharma Company Digitizes Paper Logbooks To Increase Data Accessibility

  A top pharma producer modernized its operations by digitizing paper-based logbooks. Discover how this shift supports compliance and scalability across global manufacturing environments.

• 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.

• 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.

• Eliminating USP <88> In Vivo Animal Bioreactivity Testing For Polymer Characterization

  There has been growing awareness about the environmental and ethical implications of plastics used in bioprocessing. The time for a shift to well-studied, proven in vitro cytotoxicity testing is now.