Quick Grounding: a short startup check

• In a typical month, how many individual adverse event cases does your safety team receive? Options: 0-100, 101-500, 501-2,000, 2,001-10,000, 10,000+
• Tell me about the last time you had an unexpected spike in case volume, what changed and how did your team respond?
• Walk me through your current case intake channels, including patient hotlines, investigators, CROs, and spontaneous reports Options: Patient hotline, Investigator portal/CRO feeds, EHR or third-party data, Market surveillance/social media, Other
• On average, how long does it take from first intake to a completed expedited report ready for submission to a health authority? Options: Same day, 1-2 days, 3-7 days, More than 7 days
• Who on your team owns day-to-day reporting deadlines and escalation when a case becomes reportable? Options: Head of PV / VP Drug Safety, Safety operations manager, Regulatory submissions lead, Combined responsibility, Other

Where casework slows you down

• If a single recurring workflow failure could be fixed immediately, which one would remove the most risk from your team?
• Describe the steps your team takes to triage incoming reports that might require expedited submission
• When a case requires medical review, how do you route it and who has final sign-off for causality? Options: Dedicated medical reviewer, Safety physician pool, Regional medical lead, Shared committee, Other
• Which parts of your current workflow are most manual or error-prone, for example MedDRA coding, duplicate detection, or submission formatting? Options: MedDRA coding, Duplicate detection, E2B/XML formatting, Timeline tracking, Regulatory mapping, Other
• On a scale from 1 to 5, how confident are you that no reportable case misses a deadline across all active jurisdictions? Options: 1, 2, 3, 4, 5

When reporting goes wrong, what breaks first

• When a critical submission is late or rejected, what downstream consequence concerns you most, regulatory inspection risk, product restrictions, or reputational damage? Options: Regulatory inspection risk, Fines or enforcement actions, Product restrictions/labels, Loss of partner confidence, Other
• Tell me about a recent rejection or major remediation from a health authority, what caused it and how long did remediation take?
• Which jurisdictions create the most complexity for you because of differing expedited-reporting rules or formats? Options: US (FDA), EU/EEA, UK, Japan, Rest of world / multiple APAC, Multiple regions equally
• Who in your organization must be informed immediately if you suspect a missed expedited report or a new safety signal? Options: Head of PV, Chief Medical Officer, Regulatory affairs lead, Quality/compliance, Commercial leadership, Other
• Where does validation of automated submissions typically fail in your current setup—data mapping, endpoint connectivity, or test-plan completeness? Options: Data mapping, Gateway connectivity, Test plan gaps, Environment access, Other

The alternatives you're actually weighing

• Which solution options are you actively evaluating right now, including your incumbent and any in-house build proposals? Options: Current vendor (incumbent), Internal build / homegrown system, New cloud platform vendor, Specialist integration partner, Other
• If you were to keep your current approach, what specific evidence would have to exist to justify that decision for the next 12 months?
• Who inside the company has argued for solving this without an external vendor, and what resource commitment would they need to deliver the same capabilities? Options: IT/Engineering, PV Operations, Regulatory Affairs, Combination, No internal proposal
• Which shortcomings in competitor or internal options worry you most if you were to switch to them, for example inadequate global gateway coverage or weak signal analytics? Options: Limited gateway coverage, Poor regulatory mapping, Weak analytics for signal detection, Insufficient validation support, Poor surge capacity, Other
• If a pilot proves faster case throughput and fewer submission rejections, what internal hurdle would still prevent you from moving forward quickly?

Reality check: operational constraints we cannot ignore

• Which third-party systems must integrate for a successful implementation, and do those systems provide APIs or export capabilities? Options: Safety database/legacy system, EHR/CRO feeds, Regulatory gateway, SFTP/ETL pipelines, Other
• To whom does ownership of these integrations belong, and can those owners commit time during the integration window? Options: Internal IT, PV operations, External vendor/CRO, Shared ownership, Not yet assigned
• Which data quality issues—missing identifiers, inconsistent MedDRA terms, or duplicate records—pose the biggest risk to a clean migration? Options: Missing identifiers, Inconsistent MedDRA coding, Duplicate records, Incomplete narratives, Other
• Is there an internal validation or QA process that must be completed before live regulatory reporting can be enabled, for example a 21 CFR Part 11 validation or an inspection readiness review? Options: 21 CFR Part 11 / GxP validation, Inspection readiness review, Internal QA sign-off only, No formal requirement, Other
• If a key integration owner is unavailable for the planned timeline, would that block go-live or can the project proceed with an alternate plan? Options: Block go-live, Proceed with alternate plan, Depends on which owner, Unsure

Defining measurable success and the signals you care about

• What would a successful first 90 days look like for your safety team if case intake, reporting, and signal detection improved?
• Which operational metrics do you currently track or want to track, such as median time-to-submission, submission rejection rate, or signal-detection lead time? Options: Median time-to-submission, Submission rejection rate, Time to medical review, Signal detection lead time, Case backlog size, Other
• How do those metrics translate into business or regulatory impact for you, for example fewer inspection findings or faster safety decisions?
• Which single metric, if improved by 50%, would make you decide to invest in a new platform immediately? Options: Time-to-submission, Submission rejection rate, Case processing cost, Signal detection sensitivity, Other
• On an ongoing basis, who will own tracking these success metrics and signing off that contractual acceptance criteria are met? Options: Head of PV, VP Drug Safety, Operations manager, Quality / Compliance, Other

Practical next steps and decision triggers

• Who would need to sign off internally for a pilot and who would sign for a production commitment, finance, compliance, or clinical leadership? Options: Finance, Compliance / Quality, Clinical / Medical, Head of PV / VP, Procurement, Other
• When we run a pilot that validates the key metric you chose, what would allow your team to sign a production agreement within two weeks?
• Which legal or compliance reviews must clear before we can connect to your production gateway endpoints? Options: Data processing agreement, Security review, GxP validation artifacts, Local country approvals, Other
• If there is one immovable timeline constraint, such as an upcoming inspection or launch, what date or event would force a decision to pause the project?
• Are there any budget windows or approval cycles that would accelerate or delay your ability to move from pilot to purchase? Options: Quarterly budget cycle, Annual budget, Ad hoc funds available, No constraint, Unsure

• Solution Experience: Case Intake, Submissions, and Signal Detection

• Confirm the current state and its cost
• You confirm the demonstrated end-to-end workflow removes the backlog exposure and enforces reporting timelines for the shown cases.
• Run a live replay of three provided case scenarios in a test environment and deliver results with timestamps, submission logs, and any exceptions observed.
• Provide three representative case reports, the jurisdictional reporting rules that apply to each, and one example of a past volume spike for replay.
• Map a representative case through automated intake
• You confirm the signal detection example would have identified the safety signal earlier than your current process.
• Show automated regulatory submission for one jurisdiction
• You agree on the remaining validation evidence and a concrete next test run to de-risk go/no-go decisions.
• Document and agree the validation success criteria, sign-off owners, and a target validation window for the next test run.
• Run signal detection on a sample dataset
• Validate the future state and acceptance criteria
• Forced validation, explicit confirmation

• Solution Experience: Case Intake, Submissions, and Signal Detection
• Solution Experience Deck
• Solution Brief: Case Intake and Regulatory Submissions

• meeting
• slides
• document

• Configure case intake channels
• Automate case triage and expedited flagging
• MedDRA coding and terminology mapping
• Clinical medical review and causality documentation
• Generate E2B ICSRs for regulatory submission
• Health-authority submission gateway setup
• Manage reporting timelines and escalation alerts
• Signal detection analytics and alerting
• Signal management and risk-minimization tracking
• Periodic aggregate report (PSUR/PBRER) generation
• Safety database audit trail and compliance logging
• Legacy pharmacovigilance data migration
• User provisioning and role-based access
• Surge case processing and bulk upload handling

Configure case intake channels

• How many active intake channels currently deliver individual case safety reports (for example: safety mailbox, web form, clinical trial eCRF, third-party vendor file)? Options: 1, 2, 3-5, 6+
• Which intake formats do you receive today (for example: email narrative, PDF CIOMS, E2B (International Council for Harmonisation Individual Case Safety Report) XML, CSV)? Options: Email narrative, PDF CIOMS, E2B XML, CSV/Excel, Other
• Identify the primary source systems that will feed cases (for example: your safety mailbox, the clinical trial EDC, the customer complaint system, pharmacy partner exports).
• Specify the expected weekly and peak daily volume per intake channel (estimate counts for baseline and spike scenarios). Options: Baseline <100/week, 100-1,000/week, 1,000-5,000/week, 5,000+/week
• Provide the validation or routing rule requirements for intake (for example: required fields for forwarding to case creation, mandatory reporter country, seriousness markers in the narrative).
• Confirm the owners for each intake endpoint and contact method for integration (for example: safety mailbox owner, EDC technical contact, vendor SFTP owner).

Automate case triage and expedited flagging

• Estimate the proportion of incoming cases that require expedited reporting under your safety policy (e.g., fatal, life-threatening, hospitalization). Options: <1%, 1-5%, 5-15%, 15%+
• Which seriousness criteria or regulatory triggers do you use to mark expedited cases (for example: death, congenital anomaly, life-threatening, hospitalization)? Options: Death, Life-threatening, Hospitalization, Disability, Other
• List the automation rules you want applied at intake to create triage flags (for example: keyword search, structured field matches, reporter country + product combination).
• Specify who will own triage decisions in the workflow (for example: case processor, clinical reviewer, local safety lead). Options: Case processor, Clinical reviewer, Local safety lead, Other
• Describe the escalation path and maximum allowable time-to-escalation for an identified expedited case (for example: escalate to medical reviewer within 4 hours).
• Are there jurisdiction-specific expedited rules we must encode (for example: EU serious unexpected suspected adverse reaction timelines, country-specific reportability exceptions)? Options: Yes, No

MedDRA coding and terminology mapping

• Which MedDRA version do you currently use and do you require a specific version locked for validation purposes? Options: Latest, Specific version (specify in details), Do not currently use MedDRA
• Which fields in your case record must be MedDRA-coded (for example: adverse event preferred term, primary diagnosis, medical history)?
• Specify your preferred coding workflow: fully automated auto-coding with reviewer verification, assisted coding suggestions, or manual coding only. Options: Automated with verification, Assisted suggestions, Manual coding only
• Provide the target accuracy threshold for term mapping (for example: 95% match to your coding quality standard) and any QC sampling plan. Options: 90%, 95%, 99%, Custom
• Do you require custom term mappings or local term dictionaries (for example: country-specific reporter language synonyms)? Options: Yes, No
• Identify any downstream systems that require MedDRA-coded values (for example: signal detection engine, periodic report generation, regulatory submissions).

Clinical medical review and causality documentation

• Which medical review templates or forms do you require captured per case (for example: initial causality assessment, follow-up assessment, seriousness justification)?
• Who will perform final causality sign-off in your organization (for example: delegated physician, qualified person for pharmacovigilance)? Options: Delegated physician, Qualified person for pharmacovigilance, Medical reviewer team, Other
• Specify the minimum clinical evidence you require attached to a causality decision (for example: lab reports, narrative timeline, concomitant medication list).
• Describe the expected audit trail for review actions (for example: timestamped reviewer notes, editable vs read-only fields, revision history).
• Indicate whether you require structured causality terms (for example: certain, probable, possible, unlikely) mapped to regulatory reporting fields. Options: Yes, No
• Estimate the typical review turnaround time target for initial medical assessment of a case (for example: within 24 hours, 72 hours). Options: Within 4 hours, Within 24 hours, Within 72 hours, Custom

Generate E2B ICSRs for regulatory submission

• Which E2B flavour and transport will you require for testing and production (for example: E2B(R3) XML over AS2, E2B XML via gateway test endpoints)? Options: E2B XML (ICH), E2B(R3) XML, Custom E2B variant, Unknown
• Which regulatory jurisdictions must be covered at go-live for automated ICSR generation (for example: FDA, EMA XEVMPD or local country X submission endpoints)?
• Specify the mapping sources for patient, reporter, product, and event fields into the ICSR XML (for example: case fields that map to safetyreport/safetyreportid).
• Which test cases should be included in E2B schema validation during scope (for example: serious unexpected SUSAR, non-serious foreign report, follow-up case)?
• What acceptance criteria will confirm E2B ICSR generation correctness (for example: schema validation pass rate, successful test transmissions to a regulator test endpoint)?
• Do you require automatic versioning of generated ICSR XMLs and linkage to the case audit trail for inspection readiness? Options: Yes, No

Health-authority submission gateway setup

• Which health-authority gateway endpoints do you plan to connect in scope (for example: FDA ESG, EMA EVWEB/test, national electronic reporting endpoint)?
• Identify the transport and authentication method required per endpoint (for example: AS2 certificate, SFTP credentials, API key, web services SOAP).
• Specify any scheduling or batch delivery windows required by a regulator (for example: nightly batch by 02:00 UTC, real-time push within 24 hours).
• Who will provide gateway test credentials and who will coordinate test case acceptance with the authority? Provide owner roles.
• What acceptance criteria will validate gateway end-to-end submission success (for example: receipt acknowledgement (MDN) from authority, test submission pass for defined test cases)?
• Do any endpoints require specialized message transforms or attachments (for example: inclusion of CIOMS PDF alongside E2B XML)? Options: Yes, No

Manage reporting timelines and escalation alerts

• Which regulatory reporting timelines must the system enforce (for example: 24-hour expedited, 7-day follow-up, periodic deadlines)?
• Specify the permissible clock source for timeline calculations (for example: report receipt date/time in UTC, local reporter time). Options: UTC, Local reporter time, Case creation timestamp
• Who should receive automated escalation alerts and at what thresholds before expiry (for example: 48 hours before, 24 hours before, overdue)?
• Describe required SLA categories and associated notification recipients (for example: initial triage SLA, medical review SLA, submission SLA).
• Indicate whether timeline exceptions or regulatory extensions should be recorded and how proof of extension will be stored. Options: Yes, No
• Provide any country-specific business rules that alter reporting timelines (for example: local expedited exemptions, calendar-based holidays).

Signal detection analytics and alerting

• Which signal detection methods do you expect to run in scope (for example: disproportionality metrics like PRR/ROR, time-to-onset clustering, cohort-based rates)? Options: PRR/ROR, Time-to-onset, Observed vs expected, Custom algorithms
• How often should automated signal detection run (for example: nightly, weekly, monthly)? Options: Nightly, Weekly, Monthly, Ad-hoc
• Specify the minimum data completeness threshold for a dataset to be included in a signal run (for example: % of cases with MedDRA-coded events, % with exposure dates). Options: 70%, 80%, 90%, Custom
• Who will own triage of flagged signals and what evidence package do you require exported per signal (for example: supporting cases, stratified counts, concomitant drug lists)?
• Describe alerting thresholds that should trigger an automatic investigation record (for example: PRR >2 with chi-square p<0.05).
• Do you require linkage between signal outputs and periodic report sections (for example: PSUR/PBRER line listings)? Options: Yes, No

Signal management and risk-minimization tracking

• Which signal lifecycle stages must be tracked (for example: detection, validation, assessment, recommendation, closure)? Options: Detection, Validation, Assessment, Recommendation, Closure
• Specify the artifacts required per signal assessment record (for example: ICSR line listings, clinical assessment memo, regulatory communications).
• Who will have authority to approve risk-minimization actions and how should approvals be recorded?
• Provide required metrics for tracking risk-minimization effectiveness (for example: reduction in reporting rates, DHPC distribution logs).
• Are there external stakeholders that must be notified or have access to signal records (for example: local safety reps, regulatory affairs)? Options: Yes, No
• Do you require automated reminders or review cadence workflows for ongoing signal monitoring (for example: review every 3 months)? Options: Yes, No

Periodic aggregate report (PSUR/PBRER) generation

• Which periodic aggregate report types and jurisdictions must be generated in scope (for example: PSUR/PBRER EU cycle, FDA periodic reports, country-specific aggregate reports)?
• Specify the reporting period boundaries and any retrospective data windows required for the first report.
• Identify required tables and line listings for the report (for example: ICSRs by seriousness, adverse reaction frequencies, drug utilisation denominators).
• Who will own final sign-off for the periodic report and what supporting documentation do you require archived with the report (for example: signal assessments, data extracts)?
• Do you require submission-ready output formats for authorities (for example: PDF with annexes, XML payloads, Excel line listings)? Options: PDF, XML, Excel, Combination
• Are there mandated timelines for periodic report filing we must encode and monitor (for example: PSUR submission window in the EU)? Options: Yes, No

• Master Services Agreement (MSA)
• Statement of Work (SOW)
• Subscription and Order Form
• Service Level Agreement (SLA)
• Data Processing Agreement (DPA)
• HIPAA Business Associate Addendum (BAA)
• Validation and Acceptance Protocol
• Change Order Agreement
• Pharmacovigilance Compliance Addendum

• Go-live Health Check (weeks 1-4)
• First Measurement Review (weeks 4-10)
• Acceptance Gate Review (around day 90)
• Operational Monthly Review
• Quarterly Compliance and Signal Detection Review

• Commit to a concrete backlog schedule for compliance-impacting enhancements and define verification criteria for their release.
• Schedule required re-testing windows for E2B submissions and data migration validation prior to the acceptance gate.
• Restate acceptance criteria and numeric targets
• Produce a documented acceptance decision that records pass/fail status per acceptance criterion recorded in Solution Scope.
• Agree remediation items and resolution timelines for any criteria not fully met, and define the verification process for closure.
• Publish the acceptance record with pass/fail outcomes and any required remediation plan and verification dates.
• Schedule follow-up verification tests and a closure check for any conditional acceptance items.
• Ops dashboard and SLA review
• Ensure operational SLAs are met or have a documented remediation plan for any breaches, and confirm improvement trajectory for late submissions and ticket resolution time.
• Re-confirm success criteria and owners
• Publish the monthly SLA report with trend lines and a remediation plan for any jurisdictions with repeated late submissions.
• Prioritize the top five enhancement requests that materially reduce compliance risk and publish estimated delivery windows.
• Signal detection performance
• Validate that signal detection performance meets internal SLA targets and agree tuning actions where detection speed or accuracy falls short.
• Confirm periodic report readiness and close any outstanding inspection or audit artifacts required for regulatory review.
• Update signal detection configuration with agreed threshold and rule changes and document expected impact metrics for the next quarter.
• Publish an inspection-readiness checklist with the status of all required artifacts and dates for closure of missing items.
• Confirm that critical integrations (E2B gateway, submission endpoints) are responding and that no high-severity defects block regulatory submissions.
• Agree owners and remediation timelines for all open high-priority issues to restore full operational capability within the immediate hypercare window.
• Publish the go-live validation checklist with pass/fail statuses and remediation timelines.
• Circulate a short-term adoption support plan listing targeted training sessions and office-hours times for users showing low activity.
• Present first-window outcomes
• Determine whether percent of expedited submissions on time and average case processing time are trending toward the targets recorded in Solution Scope.
• Document a corrective action plan with measurable verification steps to close any gap before the acceptance gate.
• Publish the gap analysis and corrective action plan with explicit verification tests and target dates.
• Deployment and integration validation status
• Support and compliance ticket review
• Present outcome data against each criterion
• Root-cause analysis for any gaps
• Aggregate safety report and periodic reporting status
• Inspection readiness and audit artifacts
• Document pass/fail per criterion
• Enhancement backlog triage
• Corrective action planning
• Early adoption and usage signals
• Confirm timeline to acceptance gate
• Short-term operational action plan
• Formal acceptance decision and next steps
• Open defects and operational blockers
• Continuous improvement log and tuning actions
• Agree immediate remediation actions