Healthcare

WHITE PAPERS AND CASE STUDIES

• Earning RMAT Designation - What Developers Need To Know

  Explore a high-level overview of the Regenerative Medicine Advanced Therapy designation and how to ensure success and accelerate advanced therapy products toward commercialization.

• 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.

• Site Satisfaction: Influencing Tech Development Strategies

  Technology is playing an increasingly important role in clinical trials, helping to improve efficiency, compliance, and data quality. Learn why it’s critical that clinical study technologies are easy to use across sites and fit into the team’s workflows.

• Nevro Eliminates Majority Of Source Data Verification With ePRO And EDC

  Read how a global medical device company was able to unlock new efficiencies by implementing data collection via electronic patient-reported outcome assessments.

• Pioneering Cancer Research Meets Unparalleled Veeva Vault Integration

  A biotech company revolutionizing cancer treatment faced delays due to a complex, error-prone document review process. Discover how integrating an innovative strategy transformed their workflow.

• 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.

• 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.

• Paper Vs ePRO: Clinical Data Collection Methods

  Patient-reported outcomes (PROs) assess patients' health without clinician interpretation. Traditional paper methods often result in missing data and quality issues, while electronic solutions enhance data accuracy and completeness.

• 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.

• eCOA: Unified Approach Streamlines Processes, Speeds Start Up And Improves Data Quality

  Discover how a leading biopharmaceutical company revolutionized its clinical development with an eCOA solution that optimized its processes, cut build times, and enhanced data quality.

• How To Adopt CSA For Streamlined Computer System Validation

  Discover how the FDA’s Computer Software Assurance guidance modernizes validation by reducing compliance burdens and fostering innovation through a streamlined approach to system validation.

• Leading European CDMO For Drug Product Manufacturing

  As timelines tighten and regulatory demands grow, discover how a European CDMO delivers integrated solutions from aseptic fill and finish to packaging and release.