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WHITE PAPERS AND CASE STUDIES

• 10 Clinical Research Practices That Feel Like Compliance (But Aren't)

  Many clinical research routines are driven by habit, not regulation. This guide clears up 10 common misconceptions to streamline workflows and reduce unnecessary admin work.

• 3-Week Database Builds That Withstood FDA Review

  Learn how a lean clinical team deployed global, regulator-ready databases in just three weeks to secure immediate Phase 3 entry and transform reproductive health research.

• 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.

• From Problem To Performance: A Custom Filter That Transformed Imaging Quality

  IDEX Health & Science solved a multi-band fluorescence imaging challenge by designing Semrock filters with ultra-deep blocking, steep edges, and wider passbands for exceptional image quality.

• Mobilizing Compliance: USP 797 And 800 Pharmacy Trailer Fleet For VA Hospitals

  VA hospitals across the US are undergoing renovations to bring their facilities into compliance. The challenge was to design and manufacture a fleet of self-sufficient mobile compounding pharmacies.

• How Early-Stage Planning Strategies Are Optimizing Drug Development

  Early integration of a target product profile (TPP) into early-stage planning is pivotal for steering drug development toward both regulatory success and commercial impact.

• Effective Recruitment Capabilities And Outstanding Customer Service

  Hear from many customers who commend OpenClinica's effective recruitment capabilities, outstanding customer service, and adept problem resolution.

• 2nd Generation ATAD Provides High Quality Biosolids With Increased Capacity

  Modernize solids handling with automated aerobic digestion to manage rapid community growth. This high-rate process increases capacity, ensures Class A compliance, and significantly reduces disposal costs while providing odor-free operations through advanced nutrient and off-gas management.

• AAV-Based Gene Editing For Huntington's Disease

  LETI-101 uses AAV5 to deliver a compact CRISPR system for allele-selective editing of mutant HTT, showing promise as a one-time treatment for Huntington’s disease with strong preclinical safety and efficacy.

• 8 Ways To Achieve Higher ROI In Quality

  Is your company still using outdated methods for its QMS? It's time to evolve. Uncover how an integrated QMS can streamline operations, enhance compliance, and support your company's growth.

• Methods For Determining Equipment Capability Of Freeze-Dryers

  Observe two experimental methods for determining choked flow: the minimum controllable pressure method and the choke point method.

• Organizational Assessment For A Large MedTech Company

  Explore an organizational assessment run for a medical technology company specializing in tissue repair and regeneration, and the actionable recommendations provided to facilitate future growth.