Healthcare

WHITE PAPERS AND CASE STUDIES

• Delivering Lifesaving Intravenous Therapy Across The USA Within 24 Hours

  The goal was to successfully deliver time-critical intravenous therapy, Legalon, from a GMP Philadelphia depot to sites across the USA to treat patients suffering from amatoxin poisoning.

• Streamlining Global Respiratory Trial Complexities With Robust Data Capture Strategy

  Want to see how eCOA solutions can simplify patient-reported data capture and accelerate global trials? Explore implementation strategies, lessons learned, and measurable results.

• Seamless Onshoring From China-Based CDMO

  Successfully mitigate geopolitical risk and maintain supply continuity. Learn how a large-scale manufacturing process was rapidly requalified in eight months to secure a clinical-stage biologic program.

• Why Early Market Access Planning Is Crucial In CGT Commercial Strategy

  Bringing cell and gene therapies (CGTs) to market and ensuring patient access is a complex process. Discover how developing a market access strategy and partnering with experts can help.

• A Digital Solution Embeds Quality Into Cellular Therapeutics Production

  Discover how Dendreon cut review and release time by nearly 50% while maintaining a 99% right-first-time rate, which boosts collaboration, visibility, and operational efficiency across teams.

• 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.

• Rose Research Center Leans On Medrio To Simplify Workflows And Study Design

  After experiencing paper processing issues, discover how a company transitioned to digital data collection by using Electronic Data Capture (EDC) and Electronic Patient Reported Outcomes (ePRO) solutions.

• 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.

• Quality: The Link Between Platform, Processes, And Patients

  Quality management in healthcare and life sciences is crucial for optimizing patient health. Learn how modern quality management systems optimize patient outcomes, enhance safety, and drive operational efficiency.

• 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.

• Moving CGTx Clinical Development Forward In 2023

  Gain insights on cell and gene therapy (CGTx) clinical trial design and commercialization strategies as a panel of industry experts share their considerations.

• 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.