Government

WHITE PAPERS AND CASE STUDIES

• Making Clinical Research Better For Patients With Patient Centricity By Design

  Discover why many sponsors struggle to design and conduct studies that accommodate the perspectives and preferences of patients and caregivers.

• Clinical Trial Starts Rose At Slower Pace In 2024

  Clinical trial starts grew 5.5% to 10,503 in 2024, a slowdown from 2023’s 9.4% rise in trial starts. Sustained geopolitical and global regulatory pressures on pharma contributed to curbing momentum.

• 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.

• Navigating The Privacy Tightrope For CTIS

  Examine the challenges, potential risks, recommended best practices, and future trends related to anonymizing personal data for Clinical Trials Information System submissions.

• Cultivate Innovation And Growth At Smart, Connected Facilities

  As the US and Europe continue to lead the way in addressing a growing demand for healthcare products, explore how the global biotechnology sector is maintaining momentum and confronting future challenges.

• Today And Tomorrow: WaysTo Accelerate Decentralized And Digital Trials

  Learn about the need for investment in modern technology platforms to successfully handle the influx of new data streams available in research today, as well as those coming in the future.

• Empowering Freenome: Large-Scale Data Quality And Compliance

  Delve into five ways this biotech company was able to successfully deliver data quality and compliance for large-scale trials while developing next-generation blood tests for early cancer detection.

• Delivering Apheresis Treatment From The USA To The UK Within 24 Hours

  The goal was to perform next-day collection of temperature-sensitive tumor material for an urgent patient treatment. A flexible mitigation strategy was essential to manage short turnaround.

• Design Testing Strategies To Develop A Drug-Device Combination Product

  Leveraging the expertise and experience of a trusted partner can reduce risk and accelerate the time to market for drug-device combination products by creating an optimal Validation Master Plan.

• How Manufacturers Navigate Labor Shortages, AI, And Quality Challenges

  Review a survey that reveals key industry challenges such as labor shortages, skills gaps, and safety risks, while also spotlighting AI adoption and rising investment in quality innovation.

• Building A High-Quality IND From Scratch With Strategic Gap Analysis

  A biotech sponsor lacking in-house regulatory expertise engaged a partner to obtain strategic regulatory review, medical writing, project management, and electronic publishing (eCTD).

• Severn Trent Exceeds Leak Reduction Targets With Innovative Itron Water Solutions

  Severn Trent’s smart metering program, powered by Itron’s technology, is transforming water conservation—reducing leaks by 6 million liters, cutting costs, and empowering customers to use water more wisely.