HIPAA-compliant technology allows pharmaceutical companies to automate the laborious process of writing regulatory Clinical Study Reports on medications and bring them to market up to 40% faster

AX Semantics, an AI-powered, Natural Language Generation (NLG) market leader, announced a new range of HIPAA-compliant content generation software for the pharmaceutical sector, which will allow pharmaceutical companies to generate regulatory Clinical Study Reports (CSRs) on medications up to 40% faster by automating 30% of writing the CSR.

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“In addition to its effect on human lives and the economy, the coronavirus pandemic has exposed the hurdles pharma companies must overcome to get medication to patients. These processes are doubtless important to keep medications safe, but they also rely on outdated processes,“ said Saim Rolf Alkan, CEO and founder of AX Semantics. “Content automation driven by NLG technology connects to the clinical study database and instantly generates HIPAA-compliant, auditable reports that help pharmaceutical companies meet regulatory requirements at a time when getting the right medications and vaccines approved as expeditiously as possible is critical to ensure global public health.”

AX Semantics Upends the Status Quo.

The most challenging phase of bringing a drug to market is the human drug trial, or Phase III, during which time, clinicians must write a CSR that describes the pharmacological impacts and trial outcomes. Typically, data collected from the human drug trials is gathered and medical writing teams manually compile the report, however, this outdated, onerous and time-consuming process can potentially delay life-saving medications from coming to market sooner and cost pharmaceutical companies millions. A capacity challenge also exists. Writing a CSR report typically takes several months to complete, which limits the number of CSRs a team of medical writers can produce annually. Some pharmaceutical companies have tried using templates to overcome the manual writing process challenge, however the templates have been found to be too complex and rigid for the different scenarios the CSR encompasses. For example, acceptable mortality rates can differ significantly depending on the drug that is being trialed: a drug that treats late stage cancer may have a mortality rate of 8%, which is acceptable, but a rate that high for a drug that treats a migraine headache is completely unacceptable. Templates cannot deal with these types of different scenarios, which severely limits their value.

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AX Semantics content generation features for pharmaceutical and clinical study reports, include:

• NLG output based on structured data: allows users to easily configure projects to any structure and import tools and formats including JSON, CSV and Excel, and API for integration into existing systems like Oracle Databases without the need for complex IT projects;

• Topic and domain independent technology: all types of text can be generated, not just a limited set of topics — in up to 110 different languages;

• Easy-to-use interface with real-time, multi-user capability and workflows: multiple people can work on a project at the same time, allowing scaled project sizes, while retaining the ability to test and deploy; and

• Data Protection and Hybrid Cloud Availability: with certifiable processes and infrastructure that can be used for confidential information up to HIPAA/PHI level, and Sarbanes–Oxley/MARisk certifiable processes.

Named one of the world’s top five providers of natural language generation platforms by Gartner, and a top emerging company in the NLG market by Forrester, AX Semantics offers a subscription-based service, with fees between $279 and $1699 per month for pharmaceutical companies. A managed service that creates the CSR reporting is also available on top of the self-service platform for new product development purposes and customers that don’t have qualified in-house resources by utilizing the global Network of AX Semantics’ Managed Service Providers like hmmh (Serviceplan Group), Deloitte and uNaice. An industry first, this fully managed project is available at fixed flat rates with a pricing from $7,999 to $18,999, further reducing ramp up time for the project and minimizing the needed investments. The software is 100% SaaS – everything is available via a web browser, with no programming or IT departments required. Self-service with integrated e-learning allows customers to start automating text within 48 hours, often less.

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