Dr.Evidence, a leading AI-enabled landscape intelligence platform, has announced significant enhancements designed to help life sciences enterprises accelerate their time-to-market for new drugs and indications. By integrating a comprehensive set of global content, Dr.Evidence provides the critical insights needed to navigate regulatory landscapes, reduce risks, and ensure successful paths to approval.
- Comprehensive Landscape Intelligence:
- Dr.Evidence offers the broadest global content set, including over 100 million documents such as pharmaceutical labels, regulatory approval packages, clinical trials, published literature, and more.
- The platform’s specialized workflows, sharing, and monitoring capabilities provide a 360-degree view of the regulatory landscape, informing clinical development and regulatory submission strategies.
- Key Upgrades to the Dr.Evidence Platform:
- Expanded Regulatory Intelligence Module: Now includes FDA Guidance documents and content from the Orange and Purple Books, enriching the regulatory data available to users.
- Generative AI Chat Capability: This new feature allows users to interact with regulatory approval packages, enhancing accessibility and understanding of critical regulatory information.
- Enhanced Literature Search Module: Utilizes Generative AI-powered summarization to distill vast amounts of literature, improving efficiency in research and review processes.
- Label Intelligence Module: Covers regulatory data from eight major health authorities, ensuring comprehensive and up-to-date label information for users.
- Benefits of the Enhanced Platform:
- The upgrades enable pharmaceutical and biotechnology companies to increase transparency, reduce silos, and improve collaboration across departments and geographies.
- The platform serves as a central source of truth, aiding in the generation of key deliverables such as global regulatory strategy documents, briefing books, meeting packages, target product profiles, and company core data sheets.
- Enhanced capabilities support the rapid alignment on strategic decisions, ultimately advancing products to market more swiftly and confidently.
- Support for Generics and Biosimilars:
- For companies with generics and biosimilars, the Dr.Evidence platform offers proactive monitoring and notifications of changes in innovator drug labels and Orange and Purple Book content.
- This functionality supports strategy development and compliance, ensuring that organizations stay ahead of market changes and regulatory requirements.
- Industry Impact and Future Outlook:
- Rose Higgins, CEO of Dr.Evidence, emphasizes the company’s commitment to leveraging an ‘augmented intelligence’ approach that combines advanced AI capabilities with human expertise.
- The platform’s enhancements reflect Dr.Evidence’s ongoing dedication to providing precise, actionable intelligence, positioning clients for accelerated market entry and reduced regulatory risks.
- Dr.Evidence will showcase these new capabilities at the RAPS Convergence Conference in Long Beach, demonstrating its continuous innovation and leadership in the field of regulatory intelligence.
Dr.Evidence continues to set the standard in landscape intelligence for life sciences companies by enhancing its platform with powerful AI-driven tools. The latest upgrades provide comprehensive, actionable insights that enable faster, more confident decision-making in clinical development and regulatory submissions. With a focus on transparency, collaboration, and advanced intelligence, Dr.Evidence helps clients navigate the complexities of bringing new drugs and indications to market successfully.