ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• 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.

• 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.

• Bespoke RTSM Systems Empower Precision Medicine

  Randomization & trial supply management (RTSM) are critical functions of clinical trial IRT systems, supporting patient randomization plus managing drug inventory, site resupply, and participant dispensation.

• Five Key Trends In CMC

  CMC is evolving with digitalization, sustainability, supply chain resilience, post-merger integration, and personalized medicine.

• Advancing Your API To First Human Dose Trials More Efficiently

  Learn how end-to-end support for development and manufacturing, clinical trial services, advanced drug delivery, and commercial packaging can accelerate drug development and time to market.

• Building A Flexible, Challenge Resistant, Patient-Centric Clinical Supply Chain

  Flexible solutions, like demand-led supply and direct-to-patient distribution, are helping sponsors address the growing list of challenges presented by today’s increasingly complex studies.

• Advantages Of Robotic Aseptic Processing

  Examine the robotic technologies poised to increase manufacturing flexibility and efficiency while minimizing risk when bringing biologics to market.

• IRT: A New Approach To Meeting The Needs Of Early Phase Trials

  As early phase clinical trials become more sophisticated, sponsors are now leveraging flexible IRT solutions to replace error-prone manual processes and gain greater control and efficiency.

• Build A Vial-Stopper Combination Suitable For Drug Product Storage At -80°C

  This study worked to determine if the chosen vial-stopper-seal combination will remain integral while frozen at -80°C, under studied conditions, when the appropriate materials, processing, and sealing conditions are applied.

• Developing Injectable Drug Placebo Formulations For Clinical Trials

  Developing a placebo for an injectable drug requires consideration of the formulation’s impact in trials, chemistry and physical details, ethical concerns, and regulatory compliance.