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EY Smart Reviewer
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.
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
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