Healthcare

WHITE PAPERS AND CASE STUDIES

• Still Using Paper Diaries To Capture PRO Data? Read This.

  Access real-world examples of how electronic patient-reported outcome measures (PROMs) optimize data quality and reliability and improve the statistical power of trial data.

• 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.

• Novo Nordisk Harmonization Of Quality And Change Management

  See how Novo Nordisk, a global biopharmaceutical company, transitioned from a paper-based Quality Management System to an automated solution to enhance efficiency and compliance in change management.

• 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.

• Scaling With The Client In Mind: A Customer-Centric Approach To Project Scale-Up

  In today’s fast-moving biopharma landscape, scaling from clinic to commercial takes more than expertise. See how collaboration can transform scale-up and drive confident progress

• Catalent's Journey Of Continuous Improvement For CSV Excellence

  Learn how organizations must continuously reassess validation processes and digital tools to ensure compliance, enhance efficiency, and support global scalability amidst evolving regulatory expectations.

• Leveraging Single-Use Solutions To Solve Working Cell Bank Challenges

  Discover how custom manifolds enhance allogeneic therapy development from formulation to commercialization by improving process control, scalability, and efficiency.

• Advancing QC Efficiency With SEC-MALS System And Empower Software

  Discover how integration transforms lab workflows to enhance molecular characterization, streamline data management, and ensure compliance for superior data integrity and operational efficiency.

• Spotlight On India: Regulatory Enhancements, Modernization, And Robust Data Collection

  Explore India's adoption of global best practices, 24/7 work cycles, and audit readiness to ensure high standards of Good Clinical Practice, attract more trials, and provide robust data to stakeholders.

• 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.

• Is Sustainability The Key To Agile Biopharma Manufacturing?

  In biologics manufacturing, change is constant. Discover how new innovations and a focus on sustainability have gotten 62% of executives to prioritize eco-friendly practices, which reflects a commitment to long-term viability.

• A Long COVID Study Sponsor Adopts Integrated eCOA And Cognitive Assessment Solution

  eCOA tools used in a long COVID study enabled remote, real-time symptom tracking, cognitive testing, and patient-reported outcomes, ensuring high-quality data while minimizing patient burden.