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
- 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.