ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• 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.

• 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.

• Outsourcing Your Highly Potent Oncology Drug Product

  Precision oncology treatments require specialized manufacturing and packaging, leading companies to outsource production. Assessing a CDMO’s highly potent processing capabilities is critical.

• Avoiding The Risk Of A Non-Transparent Clinical Supply Solution

  With the supply chain and transportation logistics disruption caused by the COVID-19 pandemic, full documentation and complete transparency becomes even more important to avoid delays and assert provenance.

• My Worst Nightmare In RSTM: Accidental Unblinding

  Learn how collaborative efforts from study managers, supply managers, biostatisticians, designers, and clinicians can better protect the blind in clinical trials and prevent accidental unblinding.

• How A Rare Disease Biotech Replaced Manual Processes With RTSM Software

  Discover how a clinical-stage biotech automated its supply chain to protect patient enrollment and eliminate manual errors in a complex, multi-national genetic medicine trial.

• Ensuring On-Time Release Of CAR-T Cell Treatment In Spain

  Due to the COVID-19 pandemic, and the start of Brexit, a CAR-T cell treatment therapy shipment was offloaded multiple times by the airline, requiring an alternative transport solution.

• Optimized Laboratory Kitting Is Key To Successful Clinical Trials

  Clinical trials can be completely derailed by the absence of a single component, a lack of clarity in labelling, or errors in temperature-controlled logistics.

• Ensure Seamless, Efficient Delivery Of Clinical Trial Materials Worldwide

  Drug discovery companies, CROs, and CDMOs are under pressure to find supply management solutions that ensure delivery of clinical trial materials while navigating complex study designs and the regulatory landscape.