ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• 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.

• Biosample Tracking: A Consenting Dilemma

  Biosample collection is an inevitable part of most clinical trials. Learn how sponsors should be tracking every sample back to the source so as to not violate compliance issues.

• 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.

• The Critical Role Of Clinical Trial Packaging Services In Trial Success

  Compliant, accurate packaging protects product integrity, supports dosing consistency, and keeps studies running smoothly. Smart components and controlled processes lower risk across complex trials.

• European Clinical Supply Planning – Balancing Cost, Flexibility, And Time

  By evaluating the key parameters of a study, sponsors can identify the most effective location for packaging and distributing clinical trial supplies.

• 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.

• Decentralized Trials: The Value Of Direct-To-Patient, Pharmacy-Led Solutions

  Pharmacy-led DTP models cut site burden, improve inventory control, and expand trial access. Learn how to optimize your decentralized trial supply chain for compliance and patient outcomes.

• Rethinking RTSM Software: When Bigger Isn't Better

  Don’t let legacy vendor inertia jeopardize your trial. Discover why agility and deep RTSM expertise are the new benchmarks for reducing risk and ensuring precision in clinical operations.

• Sample Sizes For Performance Testing Of Combination Products, Packaging

  When developing combination products or evaluating primary packaging for drug products one must evaluate the performance of the devices and the packaging to ensure that they are fit-for-purpose.

• Delivering Apheresis Treatment From The USA To The UK Within 24 Hours

  The goal was to perform next-day collection of temperature-sensitive tumor material for an urgent patient treatment. A flexible mitigation strategy was essential to manage short turnaround.