ARARA delivers Automated Risk Assessment, Redaction and Anonymisation for EU Policy 0070 Submissions


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Standardized, quantitative and integrated risk assessment, compliant with Policy 0070 - leveraging customizable templates


AUTOMATED Document TEXT Redaction & Anonymization

Delivering rapid automation of redaction and transformation of unstructured text within PDFs and data tables with granular and customisable QC controls.

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Passively manage/monitor submission progress, expand internal knowledge and reduce vendor communication issues.

ARARA is an Automated Software Solution for Patient Data Redaction and Anonymisation 


ARARA is available as either a software-as-a-service solution, or as an managed operational service.

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Taxonomies and semantic models trained on millions of pages deliver rapid automation of unstructured patient data

Redaction and transformations are automatically configured/applied against the risk assessment outputs ensuring risk thresholds are met

Users have controls to manually intervene at every point and can correct/customize automated outputs to ensure accuracy



ARARA is a Passive Project and Workflow Management Platform


Standardized templates enable rapid submission setup, reduce time/effort when submitting to EMA and save cost

Document tracking data can be used to measure performance, share knowledge with sponsors and optimise future resource planning and timelines

Passive tracking of submission activity generates performance metrics that can be accessed on-demand, reducing the need to setup time intensive meetings



ARARA is a Fit-for-Purpose Technology Customised to EU Policy 0070


ARARA is working with and integrates with the EMA suggested risk assessment platform, ARX, an open-source collaboration out of the Technical University of Munich

ARARA has developed custom templates that enable near-instant, point-and-click risk assessment and outputs directly integrate with text automation tools

Templates are setup to meet the EMA’s 0.09 risk thresholds and provide a simplified/visual approach to evaluate risk scenarios