Lyriko MLR Pre-Check

The video presents an in-depth demonstration of Lyriko MLR Pre-Check, an AI-powered solution developed by Hyntelo, designed to optimize and accelerate the Medical, Legal, and Regulatory (MLR) review process within the life sciences sector. The core objective of the tool is to drastically reduce the time and effort spent on content revisions, which the presentation notes typically takes an average of 20 days due to frequent errors and inaccuracies in initial submissions. The solution targets brand managers and content owners who are responsible for ensuring compliance before content is released.

The central value proposition of Lyriko MLR Pre-Check is its seamless integration with Veeva Vault PromoMats, a widely used content management platform in the pharmaceutical industry. The workflow begins with the user, exemplified by the persona "Brenda the brand manager," selecting a finalized document directly within Veeva Vault PromoMats to initiate the AI pre-check. The user is then guided to a control panel where they can customize the analysis by selecting from six distinct categories: Spelling and grammar, Claims, Medical, Legal, Regulatory, and Tone of Voice. This customization extends to setting the severity level for the analysis and assigning specific reviewers to oversee the findings for each category, allowing for targeted internal quality assurance.

Once the pre-check is launched, the system generates a comprehensive analysis summary accessible to both the content owner and the assigned reviewers. This summary is highly actionable, featuring highlighted text that requires attention, color-coded comment call-outs corresponding to the specific pre-check categories, and clear, actionable insights for addressing identified issues. By implementing this pre-submission quality gate, the solution aims to significantly increase the quality of the content before it enters the formal MLR workflow. The video claims that using Lyriko MLR Pre-Check results in a "significantly higher chance of first-round approval," citing a specific metric of up to a 7% increase in first-time validation success. Ultimately, the tool is positioned as a strategic asset for streamlining regulatory adherence, enhancing the quality of promotional content, and accelerating the overall time-to-market for pharmaceutical materials.

Key Takeaways: • Addressing MLR Bottlenecks: The solution directly tackles the inefficiency of traditional MLR processes, which are cited as taking an average of 20 days to complete due to numerous revisions and inaccuracies in initial content submissions. • Veeva Ecosystem Integration: Lyriko MLR Pre-Check is designed for seamless operation within the Veeva Vault PromoMats environment, ensuring that the pre-check process is initiated directly where content resides, minimizing workflow disruption. • Quantifiable ROI on Validation Success: The tool promises a tangible improvement in content quality, claiming an increase of up to 7% in the rate of first-time validation success for submitted materials. • Customizable AI Analysis Categories: Users can tailor the pre-check to their specific needs by selecting from six detailed analysis categories: Spelling and grammar, Claims, Medical, Legal, Regulatory, and Tone of Voice. • Granular Control and Reviewer Assignment: The system allows brand managers to set the severity level for the AI analysis and assign one or more specific internal reviewers to manage the feedback generated for each distinct category. • Actionable Feedback Mechanism: The output is not merely a list of errors; it provides a summary that includes color-coded comment call-outs, highlighted text indicating issues, and clear, actionable insights designed to guide content owners in making necessary corrections swiftly. • Strategic Pre-Submission Quality Gate: By performing a rigorous AI-powered analysis before formal submission, the tool functions as a critical quality gate, ensuring content is optimized for compliance and accuracy, thereby reducing friction with regulatory teams. • Acceleration of Time to Market: The primary business benefit derived from increased first-round approval rates is the acceleration of the regulatory process, enabling life science companies to bring compliant content to market faster.

Tools/Resources Mentioned:

• Lyriko MLR Pre-Check (Hyntelo’s AI-powered solution)
• Veeva Vault PromoMats (Content management platform)

Key Concepts:

• MLR (Medical, Legal, and Regulatory) Review: The mandatory internal review process in the life sciences industry that ensures all promotional and medical content is accurate, substantiated, and compliant with relevant regulations (e.g., FDA, EMA).
• First-Round Approval Rate: A key performance indicator (KPI) measuring the percentage of content submissions that are approved by the MLR team without requiring any revisions or resubmissions.
• Tone of Voice Analysis: An AI capability included in the pre-check to ensure content adheres to established brand guidelines and professional standards, particularly crucial for medical and regulatory communications.