Government

WHITE PAPERS AND CASE STUDIES

• Guide To Navigating The Complex And Expanding Regulatory Landscape

  In today’s complex landscape, organizations face growing compliance demands from diverse sources. Learn how a strong compliance system and culture of accountability drive sustainable growth and protect long-term success.

• Operationalizing Disclosure Intelligence For Compliance At Scale

  Learn how sponsors can transform compliance functions into unique strengths, not only meeting regulatory requirements but also uncovering strategic opportunities in this challenging landscape.

• Addressing PFAS Contamination In Cape Fear's Source Water: Calgon Carbon's Solution

  The Cape Fear Public Utility Authority (CFPUA) provides drinking water to more than 200,000 residents in the Wilmington, North Carolina area. In 2017, the community learned that per- and polyfluoroalkyl substances, or PFAS as they are more commonly referred, were contaminating CFPUA’s drinking water source. This led CFPUA to partner with Calgon Carbon to install Filtrasorb® granular activated carbon (GAC) to remove PFAS from the water at their Sweeney Water Treatment Plant. With this GAC addition, PFAS concentrations were reduced to levels at or near non-detection.

• Navigating The FDA's Drug Supply Chain Security Act

  Explore the transformative impact of the DSCSA on the pharmaceutical industry, which ensures stringent standards, prevents counterfeit drugs, and enhances traceability for both large corporations and small manufacturers.

• Trial Rescue: Leadership Approach To Propel Clinical Development

  Learn how Halloran's assistance was able to improve a rare disease biotechnology company’s development and operations, communication workflow, and avoid the delay of a gene therapy trial.

• Online Total Nitrogen Analysis Of Reverse Osmosis Reject Water Reduces Permit Compliance Expense By $350,000 Annually At Beverage Bottling Plant

  Learn how a beverage plant cut its annual Reverse Osmosis reject water hauling volume by 50%. Real-time Total Nitrogen monitoring reduced compliance costs by $350,000 and eliminated discharge penalty risk.

• 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.

• The Next Leap In Pharma Manufacturing

  Explore how Industry 4.0 integration transforms pharma manufacturing through connected systems, data-driven insights, and predictive, compliant operations.

• 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.

• How Digitized Protocols Are Accelerating Clinical Research

  Digitized protocols, enhanced by artificial intelligence (AI), are transforming clinical trial operations by accelerating document generation, system integration, and trial optimization.

• Leveraging Digitalization To Resolve CGT Manufacturing Challenges

  Uncover digitalization's role in overcoming manufacturing challenges in cell and gene therapies to enhance efficiency, quality, and scalability through data analytics and real-time monitoring.

• Rethinking Clinical Operations: A Smarter, Faster Playbook For Trial Success

  The CRO-sponsor partnership is now strategic, addressing communication gaps and fragmented systems to improve efficiency. Joint governance, real-time tracking, and unified technology accelerate complex trial execution.