Revolutionizing life sciences with artificial intelligence

According to analysis by the Tufts Center for the Study of Drug Development, the average cost to develop and gain marketing approval for a new drug is $2.55 billion.  A quarter of this cost is content creation and meeting regulatory requirements.

The answer to reducing this cost AND meeting regulatory demands is technology. The use of Artificial Intelligence (AI) technology is revolutionizing life sciences through contextual understanding, natural language processing, and deep learning.  Through the use of Certara’s Synchrogenix SaaS-based AI, natural-language processing technology, we have developed an approach that can process through context-based understanding rather than a structural reliant methodology.

Our content creation and writing solutions meet the promise of automated authoring and is also the most effective and efficient approach to mitigate risk for meeting requlatory requirements. Unlike other technologies, the Synchrogenix platform interprets any template or document structure with minimal training.

Certara’s clients, which include 7 out of the top 10 global pharmaceutical companies, rely on our ability to delivery speed and accuracy with content creation every time.

Authoring templates created by regulatory writers

Rely on the only electronic common technical document (eCTD) Authoring Template Suite created by regulatory writers for regulatory writers.

Creating submission-ready regulatory documents with consistent presentation, appropriate content, and eCTD compliant the first time comes with challenges.  Delays are inevitable when you consider changes in ICH and regulatory authority guidance and specifications and other factors.

Certara’s Synchrogenix eCTD authoring templates are preloaded with:

  • Proper formatting
  • Document granularity
  • Agency-specific guidance
  • Best practices for a successful submission
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Reduce review cycles with Synchrogenix Narrative Builder

Certara’s Synchrogenix Narrative Builder generates narratives quickly, efficiently, and consistently.  We can manage thousands of narratives to full completion, including review, in under 30 days. Recently for one client, Certara generated 730 narratives with full QC and finalization in just five business days.

Eighty percent of the narrative is auto-generated, pulling information directly from sources. Manual editing is only needed to ensure that the story is focused.

By generating consistent narratives, we reduce your review cycles down to just one. We eliminate two to four weeks of programming time, since our AI technology uses the source SAS SDTM/ADaM datasets instead of programmed patient profiles.  Our AI technology processes not only the clinical database but also the safety database/CIOMS forms. Furthermore, only a one-time configuration is needed.

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Save weeks with Study Report Writer

Study Report Writer is an AI-assisted writing tool that automatically generates regulatory documents with speed and reliability. We can create 80% of a first draft within 24 to 48 hours, depending on the size of source input files, which include:

  • Trial protocol
  • Statistical analysis plan
  • Tables, listings, and figures

Our technology allows writers to focus on scientifically valuable activities such as data interpretation and key message development by automating tasks such as copy-and-paste and table population.  Our system also evaluates data in tables to create fact-based, non-interpretive results text.

The impact of our AI-based approach?  We save two to three weeks of authoring time and also reduce the number of reviews required by half.

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Justin Savesky Sr. Director, Regulatory Science Technology

Justin has been immersed in the technology field for regulatory science for over eight years.  He leads Synchrogenix technology commercialization efforts, including product strategy and management.

Gabriella Mangino Regulatory Writer, Synchrogenix

Gabriella is an expert regulatory writer, authoring documents per client specifications, templates, and style guides.  She acts as the client point of contact while leading project teams and maintains proactive, and effective communication.

Dawn Guyer Director of Document Quality, Synchrogenix

With over thirteen years of experience in document quality, Dawn heads up the document quality/ QC team, which requires thorough checks for appropriate content, appearance, and compliance to style specifications on submission documents.