EY Smart Reviewer

In Life Sciences

EY Smart Reviewer is a transformational approach to reviewing the promotional materials of life sciences companies. It’s more efficient, reliable and intelligent than conventional methods – allowing better quality information to enter the market faster, while reducing risks and cutting costs.

Related topics AI Life Sciences Technology Digital

The team

Tetsuro Sano

Tetsuro Sano

Health Sciences Sector Consulting Leader; Partner, Health Sciences Sector, EY Strategy & Consulting Co., Ltd.

Nick Cernese

Nick Cernese

EY Global Health Sciences & Wellness Consulting Partner

Your business challenge | Solution benefits | Solution features & functionality | Why EY | FAQ

Your business challenge

Your business challenge

In a world of rapid, multichannel but closely regulated medical communications, the review processes for promotional materials at many life sciences companies are inefficient and inconsistent. Organizations struggle to get compliant content to market in a timely fashion. This has negative impacts on support for new and existing brands, as well as patient engagement. Challenges include:

  • New technologies are creating better ways for life sciences companies to communicate across multiple channels but have increased the demand to make information available faster.
  • Non-compliance can mean hefty fines. There can be reputational, regulatory and revenue ramifications.
  • Most Medical, Legal, Regulatory (MLR) review processes are slow, inconsistent, highly manual and expensive, costing companies tens of millions of dollars per year.
  • Most companies don’t prioritize the most important materials or the most complex questions that require experience and judgement, so subject-matter professionals often spend time checking basic data elements instead of focusing on those areas where their expertise is most needed.
  • When processes are inefficient, people disengage and take shortcuts. Quality falls, costs go up and delays and errors are more common.

Solution benefits

EY Smart Reviewer leverages artificial intelligence (AI) and machine learning (ML) algorithms to automate key activities in the review of promotional materials, helping accelerate and optimize the process. It offers:

  • Increased speed – by automating repetitive tasks and focusing on manual intervention for critical items that require experience and judgment
  • Reduced cost – by freeing up high-value people, saving money on internal and external resources, and avoiding fines
  • Improved compliance – by enabling increased objectivity and consistency and lowering risks

Solution features & functionality

EY Smart Reviewer is comprised of a series of algorithms that analyze promotional material content against guidelines by regulators and health authorities, such as the US Food and Drug Administration (FDA). EY Smart Reviewer features include:

  • A tailored risk-based decision framework co-created by key professionals including medical affairs, regulatory affairs, legal and other compliance teams, and marketing stakeholders, using risk to prioritize content for review
  • A review engine with nine modules that check compliance with regulatory guidelines around language and information consistency. The engine is enabled with AI capabilities that continually learn and improve
  • A capability to operate as a standalone platform or seamless integration with existing content management systems (e.g., Aprimo, Veeva Vault PromoMats)
  • An EY-hosted secure, cloud-based, expandable global infrastructure, including an operations center with full technical and functional support

Why EY

We combine our deep knowledge of industry regulations along with our award-winning technology capability to provide automation services and capabilities that do not exist with any other product on the market.

Your business challenge

FAQs

  • What distinguishes EY Smart Reviewer from other promotional material compliance solutions?

    EY Smart Reviewer uses AI, ML and natural language processing (NLP) to automate and optimize each step of the review process. It’s more efficient because materials move through the review cycle faster, with targeted human intervention, reducing cost and risk. It’s more reliable because it identifies and handles common problems objectively and consistently. It’s more intelligent because it is continually learning and improving. It complements other solutions that focus on workflow but lack automation.

  • What are the issues with the current Medical Legal Regulatory (MLR) review process?

    The current MLR process requires significant manual review time for documents, leading to bottlenecks, lost time and added expense. With average days to approval (ADTA) of 24 days, MLR review costs the pharma and medtech industries tens of millions of dollars per year. Organizations struggle to get compliant content in the market in a timely fashion, resulting in subpar support for existing and new brands and insufficient patient engagement. Companies are at risk for reputational, regulatory and financial damage. 

  • How will EY Smart Reviewer help life sciences companies improve their MLR process?

    EY Smart Reviewer is a technology solution that leverages AI and ML algorithms to automate key activities in the promotional materials’ review process. The solution offers:

    • Increased speed by automating repetitive tasks and focusing manual intervention on the most critical review items
    • Reduced cost by freeing up internal resources and decreasing outsourcing and fines
    • Improved compliance by enabling increased objectivity and consistency and lowering the risk of breaches

  • What kind of success has EY Smart Reviewer had so far?

    To date, the companies working with the EY Smart Reviewer tool have seen that at least 54% of errors can be managed automatically, saving 51% of reviewer time overall. The solution currently consists of nine integrated modules: risk and efficacy; language and grammar; document complexity; dosage and administration; brand and generic; and safety. We have achieved greater than 90% accuracy for each of them. More modules covering additional rules are on our development roadmap.

  • Where does EY Smart Reviewer fit in the life cycle of the MLR process?

    We suggest that the platform act as “front-of-house quality control,” following content creation and preceding MLR review, helping to ensure requirements are met and material submission quality is consistently high. By deploying the platform early on, companies can reduce the number of errors that enter the review process. EY Smart Reviewer can also be run at any point in the content development process, as documents are updated and revised.

  • Is EY Smart Reviewer compatible with most content management systems?

    EY Smart Reviewer is compatible with existing content management systems (e.g., Aprimo and Veeva Vault PromoMats) and is technology agnostic. It can also be deployed as a standalone, cloud-based solution.

  • Is there flexibility to tailor specific product enhancement requests? If so, how does that work?

    Yes. EY is eager to collaborate with clients to consider how we can integrate their specific requirements and enhancements. EY will engage with clients throughout each step of development to obtain feedback on requirements and will co-develop an agreed-upon selection and priority process.

  • What is EY’s experience in life sciences’ promotional review process?

    More than 28,000 life sciences EY professionals worldwide work across the development and commercialization cycle in a variety of settings. This includes promotional review, as well as regulatory, safety and quality engagements. We have carried out a broad range of projects in this field, including current state assessments, strategic focus and road maps to help companies achieve their best outcomes.

  • Why did EY teams develop EY Smart Reviewer?

    EY is committed to building a better working world by asking better questions and finding new answers for complex issues. By working with life sciences companies to deploy a combination of intelligent technology and human experience, we’re helping more patients access better drugs and medical devices faster.

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