ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• CDMO Support: Success In Early-Phase Drug Product Development

  As sponsors strive to deliver therapies with increasing efficiency, CDMOs are poised to remain vital, offering specialized expertise, accelerated timelines, cost efficiency, and risk mitigation.

• 7 Key Considerations For Designing The Optimal IRT/RTSM

  Sponsors can create IRT/RTSM systems that are not only efficient and reliable but also adaptable to the evolving needs of clinical research by focusing on these seven key considerations.

• Key Considerations For Selecting Flexible Fillers

  Flexible fillers are beneficial to drug developers looking for lifecycle management of their drug products. Explore key considerations for selecting flexible fill/finish manufacturing technologies.

• Investigational Medicinal Products: Labeling Changes And Their Implications

  Learn about Annex VI, which covers changes in the labeling requirements for investigational medicinal products (IMPs) and harmonizes them throughout EU countries.

• Complex Randomization Delivered Successfully

  Learn about the strategy and successful execution of a complex randomization design that helped LG Chem overcome its clinical trial challenges alongside eClinical randomization experts.

• Critical Requirements In Sourcing Comparator Drugs

  Sourcing comparator drugs has become complex in the clinical supply chain. As a result, clinical trial sponsors and pharma companies are eager to identify opportunities to overcome these challenges.

• Is Your Clinical Supply Chain Fully Optimized?

  Streamlined supply chain operations alleviate staff workload and significantly reduce IP waste. With the right partners, you can create a fully optimized, cost-effective supply chain strategy.

• Tech Transfer Strategies For mAb Drug Products In Late-Phase Launch

  Tech transfer is not just a process of replicating manufacturing steps; it is a complex, multidisciplinary effort that ensures process robustness, scalability, regulatory compliance, and supply chain readiness.

• Web-Based CDR System: Precision Without Compromise

  Validated research confirms that web-based cognitive testing maintains the millisecond precision of traditional hardware, ensuring high-quality data for decentralized clinical trials.

• Overcoming The Challenge Of Maintaining Sterility At Low Temperature Storage

  Learn about a biotech company with a recently approved gene therapy product that needed to select a packaging solution to meet their needs for storage at low temperatures and still get to market quickly.