Web Content Management

WHITE PAPERS AND CASE STUDIES

• Fulfilling MDR Requirements For A Groundbreaking Microsurgery Robot

  Discover the help a company pioneering the field of open surgery received to advance their robotic technology, replacing their former EDC system to improve their clinical research efficiency.

• 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.

• Meet The Demand: Doubling Capacity At Two 503(b) Manufacturing Sites

  503B compounders require special attention to maintain cGMP and regulation compliance. Examine the process for designing and managing new facilities for sterile and parenteral injectable manufacturing.

• Accelerating Cold Chain Expansion: Responding To COVID-19 Challenges

  Review how leveraging cross-functional teamwork helped complete a cold chain infrastructure expansion in a fraction of the expected timeline, ensuring the production of essential COVID-19 therapeutics.

• Revolutionizing Wastewater Management In Four Cities Through Water Mixing

  Historically, lift station operators have turned to chemical treatments as the primary means of managing grease buildup. However, these methods carry inherent drawbacks. 

• Fresenius Kabi Relies On Analyzer From Swan

  A global healthcare company specializing in lifesaving medicines and technologies was looking for online TOC measurement for its production site. Discover which analyzer the site chose and why.

• Bridging The Gap During Organizational Restructuring For Continuity

  Navigating workforce turnover and restructuring can threaten project timelines. Discover how leveraging an experienced on-site team can ensure long-term continuity.

• Enhancing Phase 1 Clinical Trials With Point-Of-Need Safety Assessments

  A Mobile Clinical Suite (MCS) proved to be the solution that Syneos Health needed to resolve their Phase 1 study trial challenges with comprehensive eye exams.

• Building A High-Quality IND From Scratch With Strategic Gap Analysis

  A biotech sponsor lacking in-house regulatory expertise engaged a partner to obtain strategic regulatory review, medical writing, project management, and electronic publishing (eCTD).

• Case Study: Connexin Is Taking The UK's 'Smart Cities' To The Next Level

  With Skedulo, Connexin is streamlining processes via automation, increasing connectedness between their office & field teams, and elevating their customer experience.

• Spotlight On India: Regulatory Enhancements, Modernization, And Robust Data Collection

  Explore India's adoption of global best practices, 24/7 work cycles, and audit readiness to ensure high standards of Good Clinical Practice, attract more trials, and provide robust data to stakeholders.

• Accelerating Approval Pathway For Phase III Ovarian Cancer Trial

  A late-stage biotech developing a first-in-class therapy for a rare, chemo-resistant form of ovarian cancer sought help for accelerated FDA approval.