WHITE PAPERS AND CASE STUDIES

• 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.

• Richter BioLogics Drives Efficiency And Compliance With Unified Quality

  Learn how one CDMO tripled production, improved audit readiness, and built customer trust by unifying quality systems and embracing a digital-first approach.

• Advances In Regulations For Viable Environmental Monitoring

  Viable air monitoring is critical for environmental monitoring programs in pharmaceutical manufacturing. Explore current regulatory standards as well as the impact of the EU GMP Annex 1 revisions.

• Raise The Bar: Setting New Standards For The eCOA Industry

  A paradigm shift may be necessary to increase the adoption of Electronic Clinical Outcome Assessments (eCOA) in clinical research. Explore six pivotal areas where eCOA standards can be improved.

• A Paperless Lab Simplifies, Accelerates Full Sample Lifecycle Data Management

  Implementing IDBS’ ELN helped Crown Bioscience realize electronic experimental records, optimizing our business processes and helping them to be more standardized.

• 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.

• How To Get Products To Patients Faster With A Connected QMS

  BioBridge Global faced challenges with paper-heavy processes that risked errors and delays. Discover how digital solutions streamlined their operations and improved regulatory efficiency.

• 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.

• Commercializing Rare Disease Treatment With Near Real-Time Alerts

  How did Quest help a leading pharmaceutical company overcome the data latency challenges associated with traditional EHR when recruiting eligible patients for a rare blood disorder drug?

• The EMR Interoperability Dream Vs. Clinical Research Reality

  Seamless Electronic Medical Record access promises accelerated trials and regulatory-grade evidence, but incomplete, unstructured data requires hybrid strategies using AI and human oversight to bridge gaps.

• Handle Single-Use Technology Biopharma Waste: Data Sharing, Collaboration

  Learn more about data sharing and collaboration to enable a better environmental impact of single-use technologies (SUTs) and quantifying the single-use plastic waste generated when manufacturing mAbs.

• Leveraging Life Sciences Data For Intelligent Decision-Making

  Industry 4.0 drives life sciences to prioritize data-driven decision-making by integrating advanced technologies in QMS. Discover how modern data management can improve compliance.