DIA Global 2019

Reflecting back on the busy week with the Feith Team reaffirmed how valuable Orbit software is in solving the ongoing challenges in tracking Pharma’s complex procedural activities.

Speaker & Poster Sessions: Seemed to be a general trend across presentations involving innovative initiatives that shift Pharma activities from being volume-based to value-based. Here’s a few of my highlights:

  • CIOMS Working Group XI – Patient Engagement Patient involvement in benefit risk considerations, risk minimization and prescribing information
  • TransCelerate: BioPharma R&D collaboration, PV focused initiatives looking at challenges in case intake, processing, medical assessment, & case reporting through aggregate reporting & analysis. Identifying areas of value/efficiencies to promulgate harmonization and increase quality of outcomes. Trend towards intelligent automation (vs Artificial Intelligence) to enhance existing PV operations (Orbit does this!)
  • Digital aRMM – piloting implementation tools that digitize traditional paper-based methods for additional risk minimization measures.
  • Rethinking AE Intake & Aggregate reporting processes and tools to allow for more efficiency, scalability, & quality (see ORBIT AE Inbox below)

Orbit conversations with Pharma remained vibrant Amidst all the good scientific speaker sessions, there were equally good discussions with Pharma & CROs at the Orbit booth.

Here’s what we’ve heard & are working on now:

  • Expanded Orbit Solutions It’s very clear from our conversations with clients, that Orbit’s technology & core capabilities can solve growing areas of unmet need in tracking other dynamic Pharma processes.
  • aRMM & RMP Tracking Remains best in class solutions for Pharma, even had Health Authority reps inquiring about Orbit solution
    • scalable
    • offers dashboards & reports to see bigger picture (overviews) & ability to drill down to key details,
    • helps users in manage and prioritize work (activities coming due, in progress, nearing deadline),
    • highlights areas needing attention
  • End-to-end labeling Tracking document life-cycle-management (LCM), connecting responsible stakeholders in label processes, tracking global/core/master/reference labels and with local variations
  • AE Exchange (AE REC) Solution to address a volume based need for streamlining the tracking of ICSR reconciliation with hundreds of PV vendors and business partners
  • PVA/SDEA From tracking agreement document life-cycle management and informing stakeholders, to tracking activity compliance to PVAs/SDEAs
  • AE Inbox Lots of Pharma buzz in solving this impactful volume-based challenge. Newly launched Orbit tool intelligently automating AE intake of emailed AEs reported via an AE Inbox.
  • Health Authority Communications Sharing important Health Authority safety communications with local markets/business partners and tracking local review and subsequent actions
  • PSMF From tracking master file LCM, informing and connecting responsible stakeholders in periodic reviews and updates, tracking local PSMF variations

Happy to talk more if you’d like to get more in-depth! If I missed you at DIA, let me know & we’ll be sure to connect you with some Orbit schwag.