Government

WHITE PAPERS AND CASE STUDIES

• Combining Digital Platforms And QbD Principles

  How can data and digitalization further improve pharmaceutical development and the continuous, quick, and efficient delivery of products?

• Challenges, Opportunities For Recruitment In The Digital Age

  Health literacy gaps and online misinformation hinder clinical trial recruitment. Meeting patients where they are — digitally and educationally — can improve engagement and enrollment success.

• Top 11 Considerations For Employing A Managed Service Model

  In today’s marketplace, it is becoming more attractive for companies to hire out non-differentiating capabilities. Explore 11 key considerations when taking advantage of the high value managed service marketplace.

• Rethink What You Should Expect From Your System: Modern Batch Solution

  Today’s dynamic manufacturing climate presents multiple challenges, forcing manufacturers to compare traditional and modern batch and rethink what to expect when choosing a system.

• 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.

• Removing Chaos In 3 Steps: A Guide To Planning TMF Migrations

  Knowledge and planning are the keys to successful trial master file migrations. Utilize this guide when navigating the most important part of any TMF migration: project scoping and planning.

• Improving Patient Health And Safety: Medical Affairs

  A medical affairs department needed leaders with scientific and project management expertise. With no time for training or risk tolerance, a consultant was hired to align activities with development and launch plans.

• 4 Key FSP Considerations To Optimize Drug Development

  Review several benefits of using a functional service provider model and what four things to consider before choosing a partner to help meet challenging drug development timelines.

• 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.

• Modernizing Operational Maintenance At Treatment Plants

  In 2017, the Harford County Division of Water and Sewer began looking for a modern work management solution to help automate preventive maintenance, coordinate work activities between groups, manage material inventories, and capture important data.

• 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.

• Top Biopharma Enhances Regulatory Efficiency

  Learn how this biopharma company was able to assemble project teams focused on implementing real-time document transfer for central IRB documentation and communications, significantly reducing errors and improving data management.