Case Studies

CASE STUDY

Signal and Risk Management Automation

Project Profile

Project for a top 10 biopharmaceutical company utilizing excel spreadsheet to track signal and risk management activities.

-100 + products and a user base of 100 + users worldwide including affiliates.

6-month project implementation including data import, validation, training and post go live support activities.

Customer had an audit finding related to lack of audit trail and traceability related to signal and risk management processes.

Current State

-Centralized management and tracking of signal and risk management activities.

-Downstream linkage to automate aggregate reporting processes.

Automated workflows, alerts, notification and reports.

Collaborate with other departments, partners and local affiliates.

Track decision log, review and approval history for complete traceability.

Configure organizational specific strategies to fine tune reporting plans.

Key Benefits

Elimination of 100+ spreadsheets and associated reconciliation and review time.
>50% automation using workflow and task management.
50% reduction in data entry and re-use using automation.
Alerts and auto error correction to minimize errors during planning and schedule creation.
Improved compliance and standardization of information.
Automated reporting and metrics.
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