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WHITE PAPERS AND CASE STUDIES

• Flexible Integrations To Reduce Risks And Increase Efficiencies

  Learn how a trial team kept the blind of central lab samples and patient treatment across a Phase III and extension trial, whilst optimizing the supply chain.

• Can Your Biopharma Team Keep Unplanned Downtime At Bay?

  Learn how teams reduce downtime, strengthen compliance, and respond quickly to equipment issues through proactive maintenance, smart spare parts planning, and digital troubleshooting tools.

• Project Orbis Drug Registration 2025

  Project Orbis helps streamline the review and approval of oncology medicinal products through international regulatory collaboration. Learn how this framework can accelerate your regulatory strategy.

• Relieving The Strain Of Publishing During Regulatory Registration

  Go inside how an expertly handled NDA submission for a biopharma company ensured timely FDA approval despite challenges.

• Evansville Water & Sewer Utility: 4 Tactics For Managing & Organizing Vertical Assets

  EWSU, serving 65,000 customers, revamped its vertical asset tracking with POWER Engineers to enhance maintenance workflows. Here's how they optimized their processes.

• Performance Dashboards Development

  Learn about a biotech company's successful implementation of a two-level KPI dashboard system. This enhanced performance monitoring, aligned departmental goals, and strengthened team communication.

• The Effect Of Conventional Cooling Versus Controlled Ice Nucleation On Primary Drying Time

  See how controlled ice nucleation shortens lyophilization cycles, supports higher drying temperatures, and reduces complexity for amorphous and mixed formulations without sacrificing quality.

• NDA Success Strategy: Using Non-US Clinical Data In An NDA Submission

  A sponsor acquiring a therapeutic asset from an overseas company sought assistance when including foreign clinical trial dat,a generated outside a U.S. IND, in a New Drug Application (NDA).

• Pioneering The End-To-End Decentralized Trial Experience

  This collaboration highlights the potential of decentralized clinical trials (DCTs) to transform trial execution, as well as offering a replicable model for future research.

• Early-Stage Development In Rare Pediatric Oncology

  Learn about the strategic approach a biotechnology company utilized to address significant hurdles in launching a Phase 1 clinical trial for a novel therapy targeting a rare pediatric cancer.

• Inspecting On The Edge — Understanding Punch Tip Wear

  Why is a horizontal optical comparator highly recommended for tablet manufacturers as a measuring tool for punch tip inspection, and what strategies can be used to detect, reduce, and prevent tip wear?

• The Benefits Of End-To-End Formulation And Fill/Finish Of Biologics

  Proper formulation development has a huge impact on whether a technology transfer to clinical phase fill/finish is successful. Review the challenges of transitioning a promising drug candidate.