Enterprise Risk Assessment and Migration Solution (ERAMS)

Overview

In the realm of pharmaceuticals, a variety of risks can emerge throughout the stages of drug development, exerting influence on the triumph of drug creation and clinical trials. These risks have the potential to give rise to substantial operational predicaments, such as delays in drug development, escalated expenditures, regulatory non-conformance, and more. To counteract these risks, a series of strategic measures are needed at each juncture of drug development.

During protocol development, sponsors must identify the processes and data that are critical to ensuring human subject protection and the reliability of trial results.

• At the trial and system level (enterprise, vendors, tech, etc.), organizations must identify, evaluate, and control for risks to processes and data.
• For inspection readiness, since drug development activities are subject to regulatory inspections, organizations must proactively assess risk.
• Across levels, overlap happens where one risk can affect multiple areas. Therefore, risks must be identified, monitored, and controlled at different levels (study, process, vendor).

For most organizations in the pharma industry, risk management is fragmented, manual, inconsistent, and reactive in nature. Hence, there is a need to improve the management and mitigation of risks to ensure successful development, approval, and commercialization of safe and effective drugs.

Key Features & Functionality

The main features of the solution are:

Centralized Risk Library

• A unified risk library to ensure consistency of risk documentation across the organization.
• End-to-end digital capture and coverage of study, process, and vendor risks.
• Approval workflows are configured to add/update risks in the risk library.

Digital Risk Management

• Enables risk assignment and tracking, controls (KRIs/KQIs/QTLs), and mitigation.
• Single portal for risks and issues, monitoring, documentation, communication, and governance.
• The solution enables creating and tracking different versions of RMPs.
• Approval workflows are configured to close an RMP after successful closure of all identified risks and execution of mitigation actions.

Risk Management Analytics

• Intuitive and actionable reports for evaluation of risk management effectiveness, risk interconnections, sources, and consequences.
• Data-driven triangulation of the most critical enterprise risks, enabling intelligent resourcing for risk mitigation.

Integration with external systems

• ERAMS can be integrated with any external system, such as CTMS, SAP, TMF, issue management system, as per the business’ requirements.

Benefits & Business Impact

This solution provides:

• Proactive identification, tracking, and mitigation of critical risks across domains (that is, study, vendor, and process).
• Effective cross-functional collaboration that ensures rapid decision-making and proactive communication.
• Oversight across enterprise risks to facilitate data driven decision making.