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WHITE PAPERS AND CASE STUDIES

• BSL-3 Mobile Biocontainment Laboratory For Vaccine Development Research

  The client required a freestanding COVID-19 research facility on an accelerated timeline built for continuous use in the cold climate of the northeast United States without a shell building.

• Next Generation Sequencing In Viral Safety Testing

  Next Generation Sequencing (NGS) offers a sensitive, high-throughput solution for detecting adventitious viral agents (AVAs), improving biopharmaceutical safety and accelerating regulatory-compliant product development.

• 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.

• Vibration Compensated OCXOs: Advantages, Disadvantages, And Market Applications

  Electronically compensated and mechanically isolated OCXOs each offer unique benefits for vibration-sensitive applications; choosing the right design depends on size, power, and performance requirements.

• Analytics–Powered Approach To Patient Recruitment Strategy

  In a Phase 3 psychiatry trial, a pharmaceutical company partnered with Signant to revolutionize patient recruitment through data-driven site selection using PureSignal Analytics.

• Expand Bandwidth With A Trusted Regulatory Writing Partner

  Find out how a mid-size biotech lacking the bandwidth, expertise, and resources to independently handle its regulatory writing requirements overcame this challenge.

• Symmetry Surgical Uses Software To Enhance Quality

  Symmetry Surgical enhances operations and quality management using software to improve efficiency, compliance, and data-driven decisions while producing over 2 million surgical devices annually.

• Rapid Startup Phase 1 Cardiomyopathy CRISPR Gene Therapy

  Hereditary transthyretin amyloidosis (ATTRv) is very rare, prompting a Phase 1 trial of in vivo CRISPR/Cas9 gene editing to reduce mutant protein and stop cardiomyopathy progression.

• Elevating Diverse Patient Voices To Inspire Clinical Trial Participation

  Explore the innovative approach taken during this clinical trial partnership to address the underrepresentation of minority communities in clinical trials through digital storytelling.

• Eliminate Clinical Trial White Space With The Right AI Strategy

  Learn how sponsors and CROs are using agentic AI to eliminate the unproductive time caused by manual, sequential processes and fragmented data systems.

• 5 Steps To Design A Microbiological Performance Qualification For Facilities Explore five steps to design an EMPQ for sterile manufacturing: classification, protocol drafting, cleaning evaluation, disinfectant efficacy testing, and continuous improvement.
• Modifying The Micro-Environment To Improve Dissolution Rate

  Discover how modifying the micro-environment with targeted excipients can significantly enhance the dissolution rate of poorly soluble drugs using conventional manufacturing methods.