ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• Unblinding Risks In RTSM: What's Still Going Wrong, And How Korio Fixes It

  Protecting study integrity requires more than just luck. Learn how systemic gaps lead to unintentional unblinding and how a proactive, engine-based approach can safeguard your clinical data.

• Vial Containment Systems For Gene And Cell Therapies

  CZ vial-stopper-seal combinations offer a viable solution for the challenges associated with low-temperature storage of cell therapy drug products.

• Flexible Integrations To Reduce Risks And Increase Efficiencies

  Learn how a trial team kept the blind of central lab samples and patient treatment across a Phase III and extension trial, whilst optimizing the supply chain.

• RTSM And Clinical Drug Dispensation

  A pharma company used Signant Health's RTSM solution in a Phase 2 schizophrenia trial to ensure drug availability, maintain study balance, prevent duplicate allocations, and manage returns and destruction of unused drugs.

• 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.

• 5 Tips To Put The Right Systems In Place For Successful Clinical Trials

  Before you dive into clinical trials, ask yourself: Is my company operationally ready to handle the complexity? Learn about key upgrades that can help you streamline operations and reduce risk.

• Treating Deficiencies In Employee Training And Mentorship

  Investing in employee training and development is not just beneficial for the employees. It also contributes significantly to the organization’s success and competitive advantage.

• Inside A Gene Therapy Facility, Commercialization & Industrialization Project

  An inside look at a clinical-stage company focused on bringing its gene therapy from the lab into a clinical setting for patients and families devastated by rare neurological genetic diseases. 

• Five Key Trends In CMC

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

• IMP Labeling: EU CTR Transition Considerations

  Review current requirements as outlined by the EU Clinical Trial Regulation, supporting guidance, and three key considerations when planning IMP labeling activities for ongoing studies.