e-data Implementation Impact Discussion Panel Summary of Experiences & Challenges for Pharma, CROs, Software Vendors, Consultants & Regulators 2018 CSS 06 Mar 2018

Breakout 2 - Impact Panel Discussion Method: Distribute the attendees to 5 tables - each dedicated to their “industry” Pharma, CROs, Software Vendors, Regulators, Consultants Each group to answer, from their perspective: What are the best impacts of e-data submission requirements on your organization? What challenges have you overcome? What current challenges are you facing?

Pharma 1 of 3 Best Impacts Data visualization increase data review speed & enhanced interpretation Use of data visualization able to influence organization (company?) Forcing standardization Structured data warehouses Organized way to retrieve data from CROs (data repatriation) Surfaced assumptions that were not previously identified

Pharma 2 of 3 Challenges Overcome Senior management SEND buy-in Terminology mapping (somewhat still a challenge) Learning lingo/terminology Establishment of a data management group Merging of datasets (multisite studies) into one submission Challenge of 2 systems talking to each other (e.g., ECG, TK, worklists) Pharma/CRO alignment on what should be in a dataset Use of data visualization able to increase engagement of scientists with SEND User communities coming together to influence tools

Pharma 3 of 3 Current Challenges Study Data Standardization Plan (SDPS) – getting alignment across clinical, nonclinical & regulatory Generating SEND datasets for studies with challenging designs (e.g., escalating dose and what is day 1 for x group) Delays in getting datasets – can’t visualize data internally before submitting/reporting Multisite studies – coordinating communications, handoffs, timing, SDRG generation, org limitations Gaps in data collection systems that can’t generate SEND datasets (manual generation required) Getting quality & conformance when dealing with different CROs (lack of harmonization) Unscheduled activities can be more difficult to handle in SEND than scheduled Some domain variable still subject to interpretation – leading to inconsistencies – examples? Study endpoints that aren’t in SEND yet won’t be included Concern that nonclinical could become rate limiting at NDA submission Projecting resources & costs dependent – can be dependent on strategy when generating a dataset Getting more frequent feedback from agency to understand if we are doing a good job

CROs 1 of 2 Best Impacts Challenges Overcome Consistency in data collection and controlled terminology All around better communication Streamlining work processes Driven upgrades/updates Challenges Overcome Tool flexibility/manual manipulation Adjusting to change Purchasing & implementing software/commercial products

CROs 2 of 2 Current Challenges Lack of feedback Educating clients (needs & costs) Verification/QC Resources (timelines, employee needs, charge costs) Keeping up with the standards Organizing data from outside vendors

Software Vendors 1 of 2 Best Impacts Challenges Overcome SEND investment Data collection – submission warehouse Upgrades Data sharing projects Challenges Overcome Consumption SEND Automation checking Trial summary population Collection  output

Software Vendors 2 of 2 Current Challenges Visualization desired But don’t have any scope to provide Data from multiple LIMS including handwritten records Harmonizing into a single cohesive dataset Data gaps Specimen or other data not captured in the LIMS system. Filling and adding information traditionally not stored in the LIMS Unstructured data (correlations) Data correlation via narrative Data collected – SEND aware CT Study Summary tables based on same system creating SEND output Increase harmonization of report and SEND dataset Moving target of SENDIG 3.0 interpretation - TCG requires changing implementation of SEND variable

Consultants Best Impacts Business opportunities Revenue stream It is the business Innovation Renewed interest in the usefulness of legacy data Moving to future use of data – it’s not just one drug, one study, one submission

Consultants 1 of 2 Challenges Overcome Custom SDTM datasets QC checking – finding inconsistencies Filling the gap for expertise, education & workforce Providing a level of reassurance, confident responses Tools – creation, vetting & using

Consultants 2 of 2 Current Challenges SEND still an infant – change happens, but movement is not synced up Lack of consistent feedback from regulators Lack of platform for information sharing Data collection practices have not caught up – unwillingness to optimize input Trial design Access to multiple tools Divergence between SEND output and the study report

Regulators/Standards Organization Best Impacts Getting usable data Using CDISC standards Challenges Overcome Issuing guidances Pilots Current Challenges Training Heterogenicity of implementation Harmonization of standards