By integrating people, processes and technologies, life sciences are transforming their Medical, Legal, and Regulatory (MLR) digital content workflow. Achieving success depends on mastering three essentials: a risk-based review process, an updated operating model, and technology-driven transformation.
For life sciences organizations, implementing an efficient, streamlined, cross-functional review of digital content and other external communications helps ensure they are accurate, compliant, and aligned with regulations before being released. Today, the MLR content operating model is undergoing a major transformation, fundamentally reshaping how people, processes and technology work together to deliver effective and compliant content.
Organizations embracing this change are able to unlock clear benefits such as increased speed, efficiency, compliance and cost savings. Achieving these results requires a critical focus on the entire end-to-end content lifecycle, ensuring key stages are integrated while optimizing investment in AI-powered capabilities.
To succeed in this evolving landscape, life sciences should master three essentials to achieve agile content review:
1. PROCESS: Harnessing a risk-based approach to content review
Traditional, one-size-fits-all MLR reviews are often insufficient and can drain precious time and resources. A risk-based approach helps transform content review by aligning scrutiny with actual risk. By rapidly assessing each asset against key risk drivers, organizations can accelerate approvals and focus attention where it matters most.
Case in point:
A leading biopharmaceutical company engaged us to help them build and pilot a risk-based, digital workflow. The result: 90% of content required review by all review functions, but after implementing a risk-based approach, only 50% of content required review by all reviewers.
2. PEOPLE: Operating model and content governance for the future
Medical content review is inherently complex, involving multiple stakeholders and, increasingly, shifting decision-making to commercial teams. As this shift accelerates, it is more important than ever to clearly define roles and responsibilities to ensure maintain governance and strong cross-functional alignment.
Organizations need to distinguish between global and local needs, tailoring governance frameworks to fit their unique context. Throughout our work with leading life sciences organizations, our industry practitioners have seen that integrated models can deliver fast, sustainable results by enabling agile, data-driven planning, cross-functional collaboration, and flexibility to support local responsiveness.
3. TECHNOLOGY: Implementation and digital transformation
Technology and artificial intelligence (AI) are the engines of modern content workflow. By integrating AI and workflow tools, organizations can automate key steps throughout the content lifecycle—improving content quality, streamlining reviewer focus, and reducing review times. Automation can proactively check submissions for quality, brand standards, claim validity, scientific accuracy, and risk before content review even begins. During review, AI can support reviewers in assessing complex, subjective issues based on policy and regulatory guidance. After review, these tools verify that only requested changes have been made and flag any new content that may require further compliance checks.
Building a seamless user experience in the review process relies on integrated systems, orchestrated handoffs, and clear business rules. Deloitte Digital has developed a proprietary, AI-enabled content review solution designed to create more seamless interactions between marketers and reviewers, reducing manual errors and accelerating review cycles.
Change management and community of practice
Transformation requires more than new processes and tools—it demands a shift in culture and mindset. Organizations should embrace innovation, foster agile practices, and build communities of practice to drive adoption and continuous improvement. Support from senior leadership is essential and demonstrating the value and benefits of the change prior to rollout is required. This can make new ways of working stick.
What’s next?
The imperative for digital content review transformation is clear: Life sciences should reimagine the content review process to deliver compliant, high-quality content at speed and scale. By mastering risk-based review, a right-sized operating model, and digital transformation, teams can meet customer expectations, all while delivering the right information at the right time.
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