Certara’s Synchrogenix Unit Provides Solution to Enable Pharma Compliance with EMA Policy 70

March 24, 2016

PRINCETON, NJ – Mar. 24, 2016 – Certara®, the global biosimulation technology-enabled drug development company, today announced that its regulatory and medical consultancy, Synchrogenix, has introduced an artificial intelligence (AI) -enabled solution to meet the data transparency requirements of the clinical and drug development market. Those detailed requirements were published by the European Medicines Agency (EMA) on Mar. 2, 2016 as Policy 70 (http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2016/03/WC500202621.pdf).

EMA has been working with the industry for several years to develop a set of rules to make clinical trial data more public. In January 2015, the agency released new transparency and disclosure rules related to clinical study reports contained in marketing authorization applications submitted on or after that date. The first reports are expected to be made publicly available in September 2016. The rules that EMA published earlier this month expand the breadth and depth of the original rules, and provide detailed requirements for companies to follow.

“Disclosing clinical trial information so that researchers can build upon prior knowledge is an important step in bringing new therapies to patients, and fostering the industry’s commitment to the patients it serves,” said Synchrogenix President Kelley Kendle. “At the same time, we must protect the confidential patient and personal information contained in the myriad clinical reports to be published under Policy 70, which are often hundreds of pages long. In anticipation of these regulations and concerns around protecting patient privacy, Synchrogenix has developed technology that automates the redaction of personally-identifiable information, patient-protected data, and company-confidential information with 99 percent accuracy.”

Synchrogenix’s technology is the only AI-enabled solution in the biopharmaceutical industry. Built on natural language processing and recognition, this technology is able to identify individual words, parts of speech, and word and phrasing combinations automatically to determine context. This technology supports drug companies’ need to redact and de-identify datasets in their clinical study reports, patient narratives, patient data listings, and submission documents, in order to publish their clinical study information publicly. Synchrogenix’s technology is scalable and has already been successfully applied at both large pharma and smaller biotech organizations, quickly delivering accurately redacted documents.

About Certara

Certara is a global biosimulation and regulatory writing company, committed to optimizing drug development decisions. Its clients include hundreds of international biopharmaceutical companies, leading academic institutions, and key regulatory agencies. Certara’s solutions, which span drug discovery through patient care, increase the probability of regulatory and commercial success by using the most scientifically-advanced modeling and simulation technologies and regulatory strategies. For more information, visit www.certara.com.

Certara Contact:
Ellen Leinfuss, 609-216-9586
Chief Marketing Officer

Media Contact:
Lisa Osborne, 206-992-5245
Rana Healthcare Solutions
lisa@ranahealth.com

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