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WHITE PAPERS AND CASE STUDIES

• Closing The Gap In Our Understanding Of Sleep Health With DHTs

  What is the current state of sleep assessments in clinical trials, regulatory expectations, and what opportunities do wearable digital health technologies present?

• X-Ray Inspection For Supplement Safety

  Wellington Foods ensures dietary supplement safety using METTLER TOLEDO’s X37 X-ray system, which detects contaminants, and meets regulatory standards with high-speed, precise inspection technology.

• Using Virtual Study Coordinators For EDC Entry And Query Resolution To Speed Up Data Access And Cleaning

  The piece showcases how the effective use of CRIO can significantly enhance site performance, supporting recruitment and diversity objectives for sponsors.

• How To Unlock The Secret To Repeatable, Scalable Low Turnover

  Here, we explore the evolution of a 10-year partnership and extrapolate the principles that create cohesive teams and minimize turnover.

• Owen Mumford Slashes Audit Findings, CAPAs, And NCRs

  Gain insights into how Owen Mumford, a global medical device leader, enhanced their compliance and efficiency with software to reduce audit findings and improve quality management.

• 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.

• Intelligent Automation For MDR & IVDR Content

  Learn how automation can help fulfill new MDR/IVDR requirements and optimize existing labeling and documentation operations while meeting compliance.

• Evaluating Methodologies For Cooling Submersible Wastewater Pump Motors

  Compare oil-filled and closed-loop cooling methodologies for submersible wastewater pump motors, emphasizing efficiency, heat transfer, maintenance, and longevity to determine the superior cooling solution.

• Writing An IND Module 3 For Cell And Gene Therapy Products

  This whitepaper outlines the critical considerations for CGT Investigational New Drug (IND) Module 3, as well as how to avoid clinical holds and ensure regulatory readiness.

• 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.

• Breaking Barriers In Malaria Prevention With A Mobile Cleanroom

  The delivery of this mobile cGMP cleanroom facility to ACT showcases Germfree’s commitment to providing innovative solutions that meet clients' unique needs and contribute to advancing healthcare.

• Revolution In The EU Pharmaceutical Legislation Ahead

  Discover the impact revised pharmaceutical legislation will have on the industry by superseding regulations that have fostered the availability of safe and effective medicines for the past two decades.