Case Study: Patient-Centric IRT Management for Compassionate Use Studies

Life Sciences, Clinical Trials, Pharma, Pharma Manufacturing & Supply Chain,
  • Tuesday, November 13, 2018

When developing lifesaving medications for patients is at your core, it is essential to streamline the processes of managing the critical clinical supplies and trial data through advanced technology. The pooled clinical supply approach, when coupled with a comprehensive control system, offers unique strategic advantages for efficiency and data integrity. This ensures the data being submitted for drug approval is of the highest quality to help expedite the process and get the novel medications into the hands of patients who need them most.

Speakers

Brett Castano, Sr. Architect, Project Management, endpoint

Brett Castano is Sr. Architect, Project Management at endpoint. He has more than seven years of experience in the life sciences software industry and acquired a depth of knowledge in IRT and related eClinical technologies during his time as a solutions manager for both IRT providers and CROs.

Message Presenter

Craig Duffy, Senior Manager, Investigational Supply Chain Operations, Blueprint Medicines

Craig Duffy is Senior Manager, Investigational Supply Chain Operations at Blueprint Medicines in Cambridge, MA. He has over twelve years of supply chain experience. His “passion projects” at work have included developing GMP/GDP Inspection Readiness guidelines and procedures for Clinical Supply as well as evaluating ways to make IRT capabilities more useful in supply planning.

Message Presenter

Who Should Attend?

Senior professionals from pharmaceutical and biotechnology companies working within roles related to clinical trials management, including:

  • Clinical Operations
  • Clinical Supply Chain
  • Clinical Data Management
  • Outsourcing/Vendor Management
  • Supply Forecasting
  • IRT Specialists

 

What You Will Learn

  • A sponsor’s view of:
    • Challenges in synchronizing and harmonizing their pooled supply approach
    • Efficiencies of an overarching platform to manage pooled supply for both traditional interactive response technology (IRT) and investigator initiated (IIT)/Phase 1 studies to reduce manual oversight
  • Insight into implementing this approach and lessons learned
  • Ways to create other efficiencies in the future through advanced eClinical technology

Xtalks Partner

endpoint

endpoint is an interactive response technology (IRT®) systems and solutions provider that supports the life sciences industry. Since 2009, we have been working with a single vision in mind, to help sponsors and pharmaceutical companies achieve clinical trial success. Our solutions, realized through the proprietary PULSE® platform, have proven to maximize the supply chain, minimize operational costs, and ensure timely and accurate patient dosing. endpoint is headquartered in San Francisco, California, with a global footprint in the APAC region and Europe.  

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