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WHITE PAPERS AND CASE STUDIES

• How To Adopt CSA For Streamlined Computer System Validation

  Discover how the FDA’s Computer Software Assurance guidance modernizes validation by reducing compliance burdens and fostering innovation through a streamlined approach to system validation.

• Membrane Filter Pore Size Impact On Colony Size, Microbial Recovery

  Explore results from a study evaluating the effects of different pore sizes on colony size and microbial recovery using membrane filters.

• The 5 Ws Of A Human Factors Strategy

  A human factors strategy ensures medical products are safe, effective, and compliant by integrating user-focused design early, reducing risks, and optimizing regulatory approval processes.

• Quick And Easy Pipe Repair In Virginia Saves Thousands Of Dollars

  Learn how JCSA efficiently replaced ten dresser-style couplings on a 16" steel pipe spanning a 600-foot bridge using the versatile HYMAX VERSA coupling, enabling a quick and cost-effective repair without removing the pipe.

• Streamline Analytical Tech Transfer Through Analytical Target Profile

  Analytics debt in CGT can derail timelines and budgets. Learn how early ATP planning and cross-functional alignment can eliminate costly setbacks and accelerate IND approvals.

• Escondido, CA Uses Cityworks And Esri's ArcGIS® For Its Asset Management System

  Read about water utility managers who took advantage of an offer from Trimble to do a pilot program for creating a ‘system of action’ that focuses on leveraging their investment in Esri’s ArcGIS® and water sensor data, location intelligence, and analytics tools.

• Epigenetics Application Guide: RNA Modifications

  Learn about the rapidly evolving field of RNA modifications, including innovative techniques like miCLIP and RIP for mapping chemical modifications and understanding RNA’s role in cellular processes.

• 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.

• Delivering A Registrational GI Trial Through Ongoing Protocol Shifts

  A biotech developing bispecific antibodies partnered with a flexible CRO to launch its first U.S. GI oncology trial, requiring strategic insight and full-service clinical support.

• Addressing Site Selection Challenges In DMD Gene Therapy Studies

  Effective site selection is critical for the success of DMD gene therapy trials. This study details innovative methodologies employed to streamline and improve site identification.

• Addressing The Challenges In Lentivirus Harvest Clarification

  Traditional depth filtration struggles with lentiviral harvest clarification, leading to low yields and high costs. However, single-use centrifugation offers a promising alternative.

• A Blueprint For Smart Water Management

  Ferrán Bosch, Senior Business Development Manager Xylem Vue at Xylem, speaks with Koldo Urkullu, Director of Operations and Asset Management at CABB, about how a utility is innovating to meet volatile weather patterns head-on.