ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• Understanding Post-BREXIT Regulatory Changes Impacting the Clinical Trial Supply Chain

  With many BREXIT provisions now in effect and more to come, supply chains serving clinical trials in the UK and/or EU member states must navigate a complex web of new regulations.

• Specializing In Small And Early-Stage Partners, Not Just Small Batches

  Many small and/or early-stage companies are not aware of the need, or the possibility, of finding a CDMO that specializes in meeting their specific requirements.

• Time, Logistics, And Manufacturing In Autologous Cell Therapy Clinical Trials

  Learn how the establishment of effective guidelines and standardization relevant to cell therapy development can help to minimize delays and lead to more positive outcomes.

• Planning Your Packaging For A Seamless Transition From Clinic To Launch

  Explore how clinical and commercial teams should work together for clinical supply packaging, how the COVID-19 pandemic has changed things, and what to consider when looking for a packaging partner.

• RTSM: Randomization And Cohort Management, IP Inventory Management

  Signant’s SmartSignals® RTSM solution helped an innovative biopharmaceutical company secure an FDA Orphan Drug designation for its cardiomyopathy drug.

• A Supply Chain Management Solution Designed for Clinical Research

  In this use case, follow along the clinical supplies management journey to learn how GxP Inventory replaces fragmented, spreadsheet-based processes to optimize visibility, traceability, and compliance.

• Overcoming Cell Therapy Supply Chain Challenges

  For the industry to realize the potential of cell and gene therapies (CGTs), we must develop improved solutions that reliably support the control and transport of critical CGT raw materials and products.

• Comparator Drug Sourcing Solutions: Network Effects

  A well-known, mid-size, multi-national pharmaceutical company needed a large supply of comparator drug to begin comparative clinical trials for a rare disease.

• Direct-To-Representative Sample Distribution Services

  One particularly effective approach to promote prescription drug products is to have pharma sales reps ‘hand carry’ samples to the health care practitioners within their territories.

• Optimizing Direct-To-Patient Supply Management: ClinChoice And 89Bio

  Learn how the CRO ClinChoice and the sponsor 89Bio were conducting a phase II, randomized, double-blind, placebo-controlled study that needed to pivot to a decentralized protocol during the pandemic or face trial disruption.