LifeSphere Safety Overview Video for Small and Emerging Biopharma

This video provides an overview of ArisGlobal’s LifeSphere Safety platform, specifically tailored as a modern, scalable drug safety solution for small and emerging biopharmaceutical companies. The presentation frames the decision facing these firms: whether to outsource their drug safety system or bring the function in-house. The core argument for adopting LifeSphere Safety is that owning the system provides greater control, efficiency, and scalability, enabling emerging companies to manage their pharmacovigilance responsibilities effectively while maximizing oversight of external partners. The platform is designed to efficiently collect safety data, process it within a single global database, and facilitate streamlined reporting and analytics to act quickly on critical insights.

The platform emphasizes several key operational benefits derived from bringing drug safety in-house. By owning the system, companies gain greater visibility into case workflows, compliance timelines, and overall operational status. It ensures simple, secure access for all internal and external partners, facilitating collaborative case management. A significant value proposition is the inclusion of best-in-class automation capabilities, which are production-ready on day one. This automation is crucial for managing rising case volumes efficiently, a common challenge as emerging biopharma companies advance their pipelines. Furthermore, the modern cloud architecture of LifeSphere Safety is promoted as a way to reduce internal IT costs and enable rapid deployment, often cited as being achievable in as few as eight weeks.

LifeSphere Safety is positioned as a right-sized solution built for immediate needs while offering the flexibility to scale with business growth. The system provides comprehensive, up-to-date regulatory coverage, which is essential for maintaining compliance with global health authority requirements. The licensing model is flexible, and the platform offers add-on capabilities, ensuring that the solution remains appropriate even as the company transitions from clinical trials through commercialization. This approach aims to provide emerging firms with the proven capabilities and trusted technology typically reserved for larger enterprises, ensuring operational efficiency and partner flexibility from the start.

Ultimately, the video serves as a strategic pitch for small and emerging biopharma to invest in a proprietary, cloud-based safety platform rather than relying solely on outsourced services. The focus is on achieving greater oversight, maximizing case management efficiency through automation, and ensuring robust regulatory adherence, all within an affordable and rapidly deployable structure. The platform is presented as the industry’s preferred safety solution, already utilized by hundreds of life science firms globally, reinforcing its reliability and proven capabilities in a highly regulated environment.

Key Takeaways: • Strategic Decision Point: Small and emerging biopharma companies must decide whether to fully outsource their drug safety system or implement an in-house platform to manage pharmacovigilance data and compliance. • Benefits of In-House Ownership: Owning the drug safety system (like LifeSphere Safety) provides greater visibility into critical processes, including case workflows and compliance timelines, allowing for proactive management and oversight. • Enhanced Partner Oversight: An internal system allows for simple and secure access for all external partners (e.g., CROs), enabling the biopharma company to drive greater oversight and maximize efficiency in managing partner contributions. • Automation for Efficiency: The platform delivers production-ready, best-in-class automation capabilities from day one, which is vital for maximizing case management efficiency and handling the inevitable increase in adverse event reporting as products mature. • Data Centralization and Analytics: LifeSphere Safety processes safety data in a single global database, enabling streamlined reporting and analytics necessary for acting on safety insights quickly and fulfilling regulatory obligations. • Rapid Deployment and Low IT Overhead: The solution utilizes a modern cloud architecture, which reduces internal IT costs and facilitates rapid deployment, with implementation possible in as few as eight weeks, accelerating time-to-value. • Scalability and Flexibility: The system is designed as a "right-sized solution" with flexible licensing and add-on capabilities, ensuring it can manage rising case volumes and grow seamlessly with the company's expansion from clinical development to commercial operations. • Comprehensive Regulatory Coverage: The platform ensures access to the most comprehensive and up-to-date regulatory coverage, a critical component for maintaining global compliance and avoiding costly regulatory issues. • Target Audience Focus: The solution is specifically tailored to meet the needs of small and emerging biopharma, providing access to proven, trusted capabilities that might otherwise be financially or operationally inaccessible.

Tools/Resources Mentioned:

• LifeSphere Safety (LifeSphere MultiVigilance): A modern, scalable drug safety platform offered by ArisGlobal.

Key Concepts:

• Drug Safety System: The enterprise software infrastructure used by pharmaceutical companies to collect, manage, analyze, and report adverse event data (pharmacovigilance) to regulatory authorities.
• Case Management Efficiency: The speed and accuracy with which adverse event reports are processed, reviewed, and submitted to regulatory bodies, often optimized through automation.
• Right-Sized Solution: A software solution that matches the current operational scale and budget of a smaller company but offers modularity and scalability to handle future growth without requiring a complete system overhaul.
• Regulatory Coverage: The system's ability to automatically comply with the reporting formats, timelines, and specific requirements of various global regulatory bodies (e.g., FDA, EMA).