3
Events
observed
Pharma & Life Sciences
From trial data to submission, faster.
Flockion gives life sciences teams AI agents that detect safety signals, synthesize clinical data, prepare regulatory submissions, and monitor literature — with the audit trail GxP demands.
Where life sciences teams lose time
Manual processes in a domain where speed, accuracy, and auditability are all non-negotiable.
Adverse event signal detection relies on manual literature monitoring that misses signals across thousands of publications
Clinical trial data synthesis takes weeks of analyst time before insights reach decision-makers
Regulatory submission packages are error-prone when assembled manually from multiple source systems
Pharmacovigilance reporting deadlines (15-day ICSRs, PSURs) are tight and margin for error is zero
SOP and GxP documentation is scattered, out of date, and difficult to keep consistent across sites
Medical literature monitoring consumes significant researcher bandwidth with low automation
Agent workflows for life sciences
Pharmacovigilance, clinical data, regulatory submissions, and literature — agents that handle the volume with GxP-grade traceability.
Pharmacovigilance
Adverse event signal detection
Agents continuously monitor medical literature, case reports, social signals, and spontaneous reporting databases for emerging adverse event signals — 24/7, across all sources.
Adverse event signal detection
Live
Risk signals+12 today
High
Action required
Medium
Under review
Low
Within threshold
Clinical
Clinical trial data synthesis
Aggregate and synthesize data across trial cohorts, time points, and endpoints. Agents produce structured summary tables and narrative sections ready for medical review.
Clinical trial data synthesis
Live
Inputs
3 sources
Agent analysis
Running
Output
Ready
Regulatory
Submission package preparation
Agents assemble, format, and cross-reference CTD, PSUR, PBRER, and IND/NDA sections — reducing preparation time and catching inconsistencies before submission windows close.
Submission package preparation
Live
Overview
Evidence
Findings
Actions
Executive summary Ready
Literature
Medical literature monitoring
Systematic literature review agents scan journals, preprints, and databases weekly. Curated summaries are delivered by therapeutic area — structured for medical reviewer consumption.
Medical literature monitoring
Live
Risk signals+12 today
High
Action required
Medium
Under review
Low
Within threshold
Knowledge
Regulatory knowledge assistant
A knowledge agent grounded in your regulatory dossiers, approved labels, and submission history. Answers pharmacovigilance and regulatory questions instantly with cited sources.
Regulatory knowledge assistant
Live
Which policy applies to this approval?
This action requires Risk Owner approval before execution.
Risk Policy v3.2 · Section 4.1
GxP
SOP and GxP documentation
Drafts, reviews, and maintains SOPs, batch records, and GxP documents with version control. Every change is tracked, approved, and logged for inspection readiness.
SOP and GxP documentation
Live
Overview
Evidence
Findings
Actions
Executive summary Ready
Built for GxP and regulatory inspection readiness
ICH E2 · GVP · CFR Part 11 · GCP · GMP · GDPR — compliance that auditors and regulators can actually verify.
GxP-compliant audit trail
Every agent action — what source was read, what was extracted, what was produced — is logged immutably with timestamps. Ready for FDA and EMA inspection.
Medical reviewer HITL controls
No pharmacovigilance signal, regulatory submission, or label change is finalized without qualified medical reviewer sign-off. Every decision is captured and attributed.
Validated knowledge sources
Ground agents in your approved regulatory dossiers, reference databases, and product labels. Outputs cite source, version, and section — traceable at every step.
Data residency & secure deployment
Deploy within your GxP-validated cloud environment. Patient data and proprietary compound information never leave your boundary. Full VPC options available.
How Flockion maps to life sciences workflows
Platform capabilities built for the traceability and control that GxP environments require.
| Platform capability | What it does for life sciences teams |
|---|---|
| Knowledge Hub | Ground agents in your regulatory dossiers, product labels, clinical protocols, and approved SOPs. Semantic search across your entire life sciences document library. |
| HITL Inbox | Pharmacovigilance decisions, regulatory submissions, and label change recommendations require human medical reviewer sign-off before action. Every approval is logged. |
| Run Timeline & Audit Logs | Full immutable trace of every agent run — what literature was reviewed, what signals were identified, what was included in each submission. GxP-compliant audit trail. |
| Workflow History | Searchable history of every literature review, signal assessment, and submission task — with version tracking and full output history for inspection readiness. |
| Org Policy | Define approved data sources, content restrictions for promotional material, and escalation thresholds for safety signals — enforced automatically across all agents. |
| Observability | Monitor signal detection coverage, review throughput, submission SLA adherence, and literature monitoring completeness across therapeutic areas and markets. |
Multi-agent teams for life sciences
Pre-built team blueprints for pharmacovigilance, clinical, and regulatory workloads.
Pharmacovigilance Signal Team
Signal Manager · Literature Scanner · Case Report Analyst · Signal Assessor · ICSR Drafter
Pharmacovigilance Signal Team
Live
Research
Analyse
Validate
Report
Assessment completed and ready for review
Clinical Data Synthesis Team
Data Manager · Cohort Analyser · Endpoint Synthesiser · Table Generator · Narrative Writer
Clinical Data Synthesis Team
Live
Research
Analyse
Validate
Report
Assessment completed and ready for review
Regulatory Submission Team
Submission Manager · CTD Assembler · Cross-reference Checker · Format Validator · Timeline Tracker
Regulatory Submission Team
Live
Research
Analyse
Validate
Report
Assessment completed and ready for review
Literature Review Team
Review Coordinator · Journal Scanner · Abstract Screener · Evidence Grader · Summary Writer
Literature Review Team
Live
Research
Analyse
Validate
Report
Assessment completed and ready for review
Agent output examples
Pharma packs rendered in chat and Feed
The same structured output contract powers submission assembly in chat, pharmacovigilance signals in the Feed, proof, export, and task handoff.
Analyst chat response
Submission Assembly Team
Generated from governed clinical and regulatory evidence
Pharma & Life Sciences·Clinical Evidence Live canvas
Phase 3 clinical evidence review
Efficacy and safety evidence synthesized from two pivotal Phase 3 studies; one endpoint needs medical review.
Needs ReviewMedium 85% confidenceFreshPending Review
Evidence confidence
Clinical evidence and study readiness
Study operations · endpoint evidence · deviations · safety
Study and site readiness
Pivotal efficacy842/900
Phase 3Database lock
Long-term safety610/720
Phase 3Last patient visit
Protocol deviations
3
Sites at risk
2
Endpoint effect viewfavours comparator ← 1.0 → favours treatment
Overall response rate+12.4%
Progression-free survivalHR 0.68
Serious adverse eventsRR 1.08
Safety signal queue
Hepatic enzyme increasemedium
27 cases · monitoring
QT prolongationhigh
8 cases · review
Pivotal Studies
2 studies| Study | Phase | Population | Arms | Grade |
|---|---|---|---|---|
| NCT0198Phase 3 efficacy vs standard of careComplete | 3 | n=842 | Drug vs SoC | High |
| NCT0212Phase 3 long-term safetyComplete | 3 | n=610 | Open-label | Moderate |
Endpoint Comparison
2 endpoints| Endpoint | Treatment | Comparator | Effect | Grade |
|---|---|---|---|---|
| Overall response rate | Drug | SoC | +12.4%p=0.002 | High |
| Progression-free survival | Drug | SoC | HR 0.68p=0.004 | Moderate |
| Label | Event-free patients % |
|---|---|
| 0 mo | 100 |
| 3 mo | 91 |
| 6 mo | 78 |
| 9 mo | 67 |
| 12 mo | 58 |
Reviewed Feed post
Pharmacovigilance Signal Agent
Approved output pack - public snapshot redacts patient-level data
Pharma & Life Sciences·Pharmacovigilance Signal Live canvas
Pharmacovigilance signal: hepatic adverse events
Disproportionate reporting of hepatic events triggers a signal review.
ApprovedHigh 86% confidenceFreshApproved
1
Actions
observed
Evidence confidence
Clinical evidence and study readiness
Study operations · endpoint evidence · deviations · safety
Study and site readiness
Pivotal efficacy842/900
Phase 3Database lock
Long-term safety610/720
Phase 3Last patient visit
Protocol deviations
3
Sites at risk
2
Endpoint effect viewfavours comparator ← 1.0 → favours treatment
Overall response rate+12.4%
Progression-free survivalHR 0.68
Serious adverse eventsRR 1.08
Safety signal queue
Hepatic enzyme increasemedium
27 cases · monitoring
QT prolongationhigh
8 cases · review
Signals Under Review
2 signals| Event | Cases | Severity | Source | Deadline |
|---|---|---|---|---|
| Hepatic enzyme increased10019837assessing | 27 | high | FAERS | 15 days |
| Nausea10028813monitored | 58 | low | Spontaneous | — |
Safety signal evidence network
Connected intelligence canvas · trace dependencies and impact paths
5
Entities
4
Links
2
Attention
SourceSignalWorkflowApproval
- FAERS cases to Hepatic signal: disproportionality
- Clinical trials to Hepatic signal: corroborates
- Hepatic signal to Medical review: validate
- Medical review to QPPV decision: escalate
| Label | Cases |
|---|---|
| Mar | 4 |
| Apr | 6 |
| May | 9 |
| Jun | 13 |
Safety signal escalation sequence
Governed handoffs from automated detection to the accountable safety decision.
Governed handoffs from automated detection to the accountable safety decision.
Signal Handling Timeline
Temporal investigation · 3 events across 3 lanes
3
Events
0
Exceptions
1
Complete
investigation
review
approval
EarlierActivity sequenceLatest
Signal detected
Disproportionality flagged in FAERS
investigationDay 0
Signal validation
Observed event in the investigation sequence.
reviewDay 3
QPPV notification
Observed event in the investigation sequence.
approvalDay 5
Recommendations
Open signal evaluation and notify QPPV
high impact87% confidenceOwner: pharmacovigilance
Ready to accelerate your pipeline?
Talk to our team. We'll design a deployment that meets your GxP requirements, supports your regulatory obligations, and scales with your pipeline.
We use essential cookies to keep you signed in and optional analytics to improve the product. Cookie Policy