New pharma study safety software from Canton firm

CANTON TWP.—MMS Holdings Inc., a Canton Township-based contract research organization (CRO) for the pharmaceutical industry, announced the introduction of its Datacise Integrated Safety Explorer, which will debut at the Pharmaceutical Users Software Exchange (PHUSE) U.S. Connect conference in Orlando, Fla. March 8-11.

Company officials say the tool can help drug developers detect and respond to adverse effects sooner and more efficiently. The MMS team created it as part of an industry/FDA data science innovation challenge.

The platform is built on the Microsoft Azure cloud and analyzes both traditional and emerging data sources, including social media and genomics data channels. While some analytics platforms find it difficult to ascertain why a safety signal is emerging or changing, the Datacise Integrated Safety Explorer is designed to find and contextualize these signals in real time for use in health data mining and analytics, including pharmaceutical, biotech, and medical device development and safety surveillance.

MMS officials say the software creates integrated, interactive data visualizations, which allows for quick comparisons between data from traditional and emerging, more nuanced sources. In addition, data available in the public domain can also be combined or presented side-by-side with a company’s proprietary data. This decreases the customary labor-intensive work of signal detection to help safety analysts reach an informed conclusion faster.

“The reliability and reproducibility of the Datacise Integrated Safety Explorer will allow us to go beyond the traditional dashboard analytics and answer the ‘why’ behind an adverse event,” said Margaryta Mare, medical director of drug safety at MMS. “Even well-funded projects can find it challenging to keep up with the volume of new safety information streaming from a variety of sources. This functionality gives pharmacovigilance professionals the ability to visualize this data in one place, allowing them to evaluate it in a timely fashion. The goal is to remain compliant with ever-changing surveillance regulations and to enhance patient safety.”

The Datacise Integrated Safety Explorer provides access to customizable dashboards from different data sources:

  • FDA Adverse Event Reporting System (FAERS): a public database that contains information on adverse event and medication error reports submitted to the U.S. Food & Drug Administration (FDA)
  • Canada Vigilance Adverse Reactions: a public database that contains information regarding suspected adverse reactions to health products in Canada
  • Innovative Medicines Initiative (IMI) Pharmacoepidemiological Research on Outcomes of Therapeutics by a European Consortium (PROTECT): a public, downloadable Microsoft Excel database of all adverse drug reactions listed in section 4.8 of the Summary of Product Characteristics of medicinal products authorized in the European Union
  • Side Effect Resource (SIDER): the German-based SIDER aggregates dispersed public information regarding side effects
  • Twitter Signal Detection: Datacise Integrated Safety Explorer gathers and displays safety signals as reported by users on Twitter
  • Twitter Social Media: Datacise Integrated Safety Explorer converts unstructured data to structured data with machine learning
  • Reddit Social Media: Datacise Integrated Safety Explorer provides value with natural language processing and standardization
  • Genomic: using the Allele Frequency Net Database (AFND)
  • Custom configurability for additional sources based on need, indication and client preference

Within the Datacise Integrated Safety Explorer platform, MMS has decoded hidden value in unstructured real-time Twitter posts and Reddit data, using machine learning techniques for text classification, topic extraction, deep categorization, language translation, and image classification to:

  • Filter out irrelevant noise from pharmaceutical Adverse Event (AE) posts
  • Extract relevant adverse event terms
  • Map to standards, like MedDRA and WHODrug
  • Relevant pharmacovigilance standards, like Designated Medical Events (DMEs) and severity

“Pharmacovigilance is entering a new era in data sourcing for surveillance,” said Eric Harvey, director of biostatistics and data science at MMS. “Both regulatory and commercial life sciences organizations alike are moving beyond traditional data sources, with the primary goal of bringing safer therapies to market and ensuring continued safety of marketed products. To achieve this, fresh tools and advanced techniques are needed to adequately monitor safety signals to better safeguard public health, and that’s why we created the Datacise Integrated Safety Explorer platform.”

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