Healthcare

WHITE PAPERS AND CASE STUDIES

• Developing Effective Procedures

  Effective procedure development starts with understanding the purpose and should integrate change management, risk management, and knowledge management to ensure a robust quality system.

• Life Sciences Corporation Implements eLogbooks Across 15 Sites

  New regulations challenged how surgical kits were tracked and processed across 15 U.S. sites. Discover how one team balanced compliance and efficiency to keep life-saving procedures on schedule.

• A Long COVID Study Sponsor Adopts Integrated eCOA And Cognitive Assessment Solution

  eCOA tools used in a long COVID study enabled remote, real-time symptom tracking, cognitive testing, and patient-reported outcomes, ensuring high-quality data while minimizing patient burden.

• Pharma Manufacturing: Top 10 Pitfalls To Avoid

  Pharmaceutical manufacturers face constant challenges and pitfalls common to the industry, but how can you avoid and overcome them to mitigate risk across the board?

• The EMR Interoperability Dream Vs. Clinical Research Reality

  Seamless Electronic Medical Record access promises accelerated trials and regulatory-grade evidence, but incomplete, unstructured data requires hybrid strategies using AI and human oversight to bridge gaps.

• Navigating COA Complexities For A Psoriatic Arthritis Trial

  Find out how scale management expertise helped a sponsor navigate complexities related to COA selection, acquisition, and implementation and launch their psoriatic arthritis trial on time.

• How To Adopt CSA For Streamlined Computer System Validation

  Discover how the FDA’s Computer Software Assurance guidance modernizes validation by reducing compliance burdens and fostering innovation through a streamlined approach to system validation.

• Measuring Laser Output In Medical Equipment Manufacturing For FDA Approval

  With expertise in power and energy measurement for lasers, see why Gentec-EO is the go-to choice for medical manufacturers in need of accurate and reliable laser beam measurement solutions.

• A Digital Solution Embeds Quality Into Cellular Therapeutics Production

  Discover how Dendreon cut review and release time by nearly 50% while maintaining a 99% right-first-time rate, which boosts collaboration, visibility, and operational efficiency across teams.

• How Community Oncologists View CAR T-Cell Therapy Possibilities And Challenges

  Learn how a partner with innovative solutions aimed at overcoming the barriers that limit the real-world impact of CAR T-cell therapy can make these advanced therapies more accessible and affordable.

• Oligonucleotide Synthesis: Scale-Up Made Simple

  Scaling oligonucleotide synthesis isn't as straightforward as it seems. Explore key challenges, critical process parameters, and solutions for a smooth scale-up.

• Diving Into Smart Water Management

  Learn about a water management project that established a culture of innovation and smart water management for the coastal city of Porto.