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  • Proactively Preparing For Risk Based Disclosure Submissions Across Therapeutic Areas

    Operationalizing a scalable process to manage growing demands for anonymization

    Most sponsors are experiencing pressure to achieve deadlines from Regulators to publish anonymized CSR reports and comply with risk-based anonymization policies. Having previous experience with a previous HIV risk-based anonymization trial submission, the Sponsor had a head-start in defining a repeatable and scalable process.

    As a result of in-depth training on Regulator expectations, defining re-usable templates and employing a risk-based anonymization platform from Real Life Sciences, the Sponsor has positioned their organization to achieve an accelerated timeline for their COVID-19 vaccine submission approval. 

    Expanding anonymization possesses across multiple functional & therapeutic areas

    The initial project started as a single submission with a tight regulatory deadline. The sponsor engaged Real Life Sciences’ Managed Service Team to deliver the quantifiable risk analysis and anonymized documents. The sponsor’s team in biostats, medical writing and regulatory worked closely with Real Life Sciences to set a plan and strategy. Subsequent anonymization projects included training the sponsor teams to use Real Life Sciences data anonymization solution and supporting the organization across multiple therapeutic areas.

    The risk-based approach for anonymization expanded to include additional use cases such as redaction only, rules based anonymization and study or therapeutic area specific nuances.

    To support unanticipated spikes in future demand due to the ad hoc nature of Health Canada PRCI “On Request” projects, the sponsor has planned to augment their internal teams with Real Life Sciences Managed Services.

    Enabling Scalability

    By enabling a scalable and repeatable process a single submission project has developed into a long term relationship for all regulatory and voluntary anonymization projects between the sponsor and Real Life Sciences. This includes the use of Real Life Sciences’ industry leading solution. During the initial submission a wide range of standardized inputs/outputs were delivered to enable a collaborative process across the sponsors functional areas.

    Results

    • Protected patient privacy by transitioning from a qualitative methodology (redaction based) to a quantitative risk-based anonymization process.
    • Met increasing Health Canada PRCI and EMA anonymization processing volumes for mandatory submissions. 
    • Met corporate objectives to deliver voluntary data sharing, ad hoc and dynamic risk-based anonymization projects.

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