ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• Data-Driven Adaptive Trials Enhance Safety, Progress, And Economics

  By offering guidance on optimizing ROI from extensive data collections and various endpoints in clinical studies, learn how IRT technology can enhance the data-driven approach for sponsors.

• Planning For The Return And Destruction Of Your Product

  Aspects of accountability, reconciliation, return, and destruction require significant effort to compile historical data. A little up-front planning can remove many future complications.

• Optimizing IRT For Clinical Supply Management

  Experts speak on supply capabilities within interactive response technology (IRT) – how flexibility is important to functionality and who to involve and which questions to ask in optimizing IRT for clinical supply.

• 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.

• What Does 2025 Hold For Pharma?

  Look at what’s in store for pharma and life science in 2025. While we see many recurring themes, 2025 promises to be filled with unexpected — and possibly unprecedented — developments.

• Understanding Injectable Drug Container Closure Systems

  Choosing the right container closure system (CCS) format is crucial, so understanding the different parts involved, their functions, storage requirements, and how they impact administering the drug is essential.

• 3 IRT Tactics Being Used To Streamline Supply Logistics

  Shipping and storing leading-edge therapeutics require complex logistics, but enhanced automation and process simplification ensure that sites and patients have the drugs they need when they need them.

• Quality Assured: Bringing Life-Changing Therapies To Patients

  Biopharmaceutical drug development remains a key trend, demanding specific expertise and capabilities when it comes to quality assurance. Explore four trends that matter in biologics for clinical trial supply.

• Sponsor Overcomes Hold And Steers Products Through Development

  Uncover how a small-sized biotech company was able to resolve critical regulatory CMC deficiencies to meet FDA requirements.

• 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.