Healthcare

WHITE PAPERS AND CASE STUDIES

• What 4 Things Do All eCOA Studies Need To Succeed?

  Learn what else, in addition to good technology, study teams need for eCOA studies to succeed.

• Operational Considerations For EU Clinical Trial Readiness & Execution

  Gain a comprehensive understanding of the Clinical Trial Regulation (EU) 536/2014 (CTR), which has equipped stakeholders to navigate the altered regulatory landscape and prepare for conducting clinical trials in the EU/EEA.

• 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.

• Eradicating Preventable Blindness In The Developing World

  Worldwide, approximately 285 million people are visually impaired, and 80% of these cases are the result of preventable causes. To continuously observe patients’ eyes without irritation, Forus Health’s designs incorporate both stock and custom optical components from Edmund Optics to capture high quality images in both visible and near-infrared (NIR) spectra.

• Regulatory Approval For Novel Device Achieved With Comprehensive Clinical Data Management

  Find out how data capture and management activities, programming, and medical writing for a clinical study report were supported to solve the major diagnostic challenge of distinguishing between bacterial and viral infections.

• Master Protocol Studies: Technology Considerations For The 'Never Ending' Clinical Trial

  Since the FDA is now encouraging creativity in trial designs, it is important for all stakeholders to adapt processes to follow the science and ultimately bring medicines to patients, faster. This white paper addresses the complexities that come with these trial designs, and how randomization and trial supply management (RTSM) solutions are critical to run flexible, robust, and quality-driven trials.

• Vanderbilt’s Advice For Sponsors: How To Make Working With Your EDC Easier For Sites

  Learn how research sites like Vanderbilt University Medical Center speed study timelines and drive higher quality data entry with a modern EDC.

• Real-World Data Capture With EDC

  This case study explores how a Ph.D. candidate partnered with Castor to develop software that seamlessly moves RWD between hospital systems and Castor’s EDC.

• The State Of Innovation In Europe

  Discover the current state of innovation in Europe, from pipeline constitution to emerging drug modalities, R&D alliances to financing trends.

• Top 10 Biopharma Achieves Significant Regulatory Efficiency

  Discover how a top 10 biopharmaceutical company expanded its regulatory efficiency and automated key workflows between their IRB Platform and their electronic master file (eTMF).

• Pharma Manufacturing: Top 10 Pitfalls To Avoid

  Pharmaceutical manufacturers face constant challenges and pitfalls common to the industry, but how can you avoid and overcome them to mitigate risk across the board?

• Water Utility Enhances Reliability With Integrated Technology Upgrades

  For public utilities that provide water while maintaining the physical infrastructure, it is critical to ensure reliable uninterrupted service and data integrity. This includes water metering/billing, compliance reporting, IT network cybersecurity, physical security of local and remote sites, and data collection for rate cases.