Solutions by Role

Purpose-Built for Every Stakeholder in Benefit-Risk

Whether you lead drug safety, regulatory strategy, clinical operations, market access, or medical affairs, ArcaScience surfaces the insights and outputs that matter most to your function.

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5

Roles supported

83%

Time reduction

Zero

Manual transcription

100%

Audit trail coverage

Role-Specific Benefit-Risk Solutions

Every stakeholder in the benefit-risk process has unique data needs, analytical priorities, and deliverables. ArcaScience configures its dashboards, AI models, and outputs for each function.

Drug Safety & Pharmacovigilance Leaders

Automate signal detection, PSUR/PBRER generation, and safety database analysis. Shift from manual case processing to AI-driven aggregate analysis that catches signals weeks earlier.

PSUR/PBRER Signal Reports Safety Database Reviews

Weeks spent compiling safety data manually → hours with automated pipelines

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Regulatory Affairs Professionals

Generate submission-ready documents — CTD 2.5, RMP, responses to Health Authority queries — directly from the analytical engine. Ensure consistency across global filings.

CTD Module 2.5 RMP HA Query Responses

Inconsistencies across regional submissions → unified analytical source

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Clinical Operations Leaders

Integrate clinical trial safety data with real-time benefit-risk monitoring. Support DSMB briefings, interim analyses, and protocol amendment decisions with quantitative BRA.

DSMB Reports Interim BRA Protocol Amendments

Delayed safety reviews slowing trial decisions → real-time quantitative BRA

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Market Access & HEOR Teams

Produce comparative effectiveness evidence, NNT/NNH analyses, and value dossiers for HTA bodies and payers. Translate clinical benefit-risk into economic value language.

Value Dossiers NNT/NNH Budget Impact Models

Months building HTA submissions → automated evidence synthesis

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Chief Medical Officers

Strategic oversight of the entire benefit-risk landscape. Dashboard-level visibility into signal trends, submission timelines, and competitive positioning across the portfolio.

Portfolio Dashboard Strategic BRA Board Reports

Fragmented safety data across teams → unified portfolio-level visibility

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One Platform, Every Perspective

ArcaScience provides role-specific views of the same underlying analytical engine. Every function works from a single source of truth, eliminating data silos and version conflicts.

Shared Foundation

Same Data, Different Lenses

All roles access the same curated data lake — clinical trial data, real-world evidence, regulatory intelligence, and literature. Each role gets a purpose-built view that surfaces what matters most to their function.

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Role Configurations

Role-Based Dashboards

Configurable dashboards and output templates tailored to each stakeholder's workflow. Drug safety sees signal trends; regulatory sees submission status; CMOs see portfolio-level KPIs — all from one analytical engine.

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Cross-Functional

Collaborative BRA Evidence

Cross-functional collaboration on shared benefit-risk evidence. When drug safety updates a signal assessment, regulatory sees it instantly. When market access builds a value dossier, the CMO dashboard reflects it.

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See How ArcaScience Works for Your Role

Tell us your function and we'll show you exactly how ArcaScience's dashboards, AI models, and automated outputs are configured for your specific benefit-risk workflow.

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