The challenges of Safety Vigilance in Pharma, Cosmetics, Devices, Vaccines and Nutraceuticals are creating a compelling need for a platform approach to address spiralling costs and ensure compliance.
A Business Process-as-a-Service (BPaaS) model is finding increasing interest among industry players whereby companies can get the best of modern technologies such as AI/ML, Secure Cloud Services and Analytics in a cost and time effective manner, while improving compliance to regulations related to patient safety and privacy.
The key drivers for a Safety Vigilance BPaaS solution could be listed as below:
- ➣ For Small and Medium size companies in the Life Sciences domain, implementing a standard configuration of a Cloud-based SaaS Safety Platform that delivers automation of Safety Case Intake and Processing, Regulatory Submissions and Signal Management promises to reduce the technology footprint costs via a consumption-based pricing model.
- ➣ Well-trained and qualified safety case processing teams and medical reviewers following standardised SOPs for the ‘human in the loop’ assures quality and compliance of safety processes.
- ➣The BPaaS model allows companies to scale as their products enter the various global markets.
However, to adopt a BPaaS model for Safety Vigilance, one needs a fully configurable, scalable, SaaS platform that can offer the flavours of Pharmacovigilance, Cosmetovigilance, Materiovigilance and Nutravigilance.
The Safety Platform should have Signal and Risk Management, and Literature and Social Media monitoring built-in as modules. The platform should be hosted in a secure and compliant cloud environment, and allow easy integration with Document Management Systems, CAPA systems and when required, with 3rd party Safety Databases, and with CRM systems or MICC systems for automated case intake.
In short, it should be a modern Safety Platform infused with robust AI automation services and a responsible use of AI.
On top of such a platform, one could build standard configurations and workflows for safety case processing and medical review, all the way to regulatory submission of safety cases and reports.
Operational dashboards and self-service custom report generation will be required to ensure the needs of various clients can be met without additional coding work.
Standard SOPs, global, risk-based approach to validation (Computer Software Assurance), and the availability of well-trained safety experts will complete the picture in terms of the ability to deliver a comprehensive Safety BPaaS solution to clients.
DF mSafety AI as the Safety 4.0 Framework
The DF mSafety AI Platform serves as the ideal technological foundation for a BPaaS solution in Safety Vigilance, aptly named the Safety 4.0 framework.
Components of DF mSafety AI
Automation at its Core
The platform employs AI/ML-driven automation across critical processes, achieving milestones such as expectedness prediction, causality assessment, auto-narrative generation, and more. A global cosmetics giant has achieved 80% automation in case processing, with plans to touch 100% for non-serious cases, demonstrating the platform’s efficiency.
Empowering CROs and FSPs
CROs and FSPs can leverage DF mSafety AI to deliver BPaaS to clients efficiently. The approach includes a standard configuration, client-specific variable setups, global validation, standardized SOPs, and consumption-based pricing.
Benefits of BPaaS
- ➣ Assurance of Timelines and Regulatory Compliance: Gain control over safety vigilance processes with predictable timelines and regulatory compliance.
- ➣ Minimal Footprint: No technology, human resource, or governance footprint, streamlining operations.
- ➣ Cost-Effective Technology Solution: Access a modern, configurable, and AI-powered technology solution at a lower cost compared to incumbent systems.
- ➣ Holistic Insights: Extract valuable insights beyond compliance, benefiting research and sales functions.
- ➣ Scalability for SMEs: Small and medium-sized firms can scale without upfront capital investment.
In the realm of Safety Vigilance, DF mSafety AI emerges as a beacon of innovation. Its integration into a BPaaS model not only addresses the current challenges in the industry but propels safety operations into a new era of efficiency, compliance, and cost-effectiveness.