Certara’s Synchrogenix Division and PleaseTech Partner to Streamline Document Redaction Services

PRINCETON, NJ – Aug. 4, 2016 – Certara®, the leading provider of decision support technology and consulting services for optimizing drug development and improving health outcomes, today announced that its regulatory and medical consultancy, Synchrogenix, is partnering with document co-authoring and collaborative review specialist PleaseTech Ltd. to deliver a seamless regulatory document creation process.

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A New Model to Meet BioPharm Transparency Mandates and Engage Participants as Clinical Research Partners

Studies consistently show that 90% of clinical trial volunteers expect to be told the overall results of their trial. Unfortunately, most never hear anything back from the Sponsor or research center after the last study visit, leaving many volunteers wondering if their participation was valued or appreciated. Over the past five years, the nonprofit Center […]

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Artificial Intelligence Technology

Through the use of Artificial Intelligence technology, Synchrogenix has developed a solution in the area of regulatory and medical writing that truly meets the promise of automated authoring, and is also the most effective and efficient approach to mitigate risk for meeting data transparency requirements.

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Synchrogenix ClinGenuity Redaction Management Solution (CRMS)

Synchrogenix’s unique AI engine, has created an engine that is built on natural language processing and recognition. Because of the power behind our unique AI, the engine can be configured to identify PPD and CCI the same way an individual would be trained on these definitions. The process of identifying and redacting sensitive information becomes automated and significantly more accurate.

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Regulatory and Medical Writing

High quality medical and regulatory writing is an essential part of any successful drug development program. Pharmaceutical and biotech companies need a trusted, agile, and experienced partner not only to write these documents, but also to act as a strategic partner and address key issues.

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Transparency & Disclosure in Clinical Trials

The issue of transparency and disclosure of clinical trial data has been growing in importance over the past few years. Disclosing clinical trial information and creating transparency around the data are key steps toward increasing trust between the public and the industry. Increased transparency regarding data about ongoing research could spur new products or therapeutic approaches and potentially avoid unnecessary trials.

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Engaging the Public in the Clinical Research Process

The issue of transparency and disclosure of clinical trial data has been growing in importance over the past few years. Clinical trials are essential to developing new therapies for patients. But the individuals that participate in those trial put themselves at risk. In return, the medical community has an ethical obligation to disclose clinical trials […]

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Synchrogenix Transparency Service Case Study: Sponsor B

Sponsor B, a top-10 pharmaceutical company, supports policies and actions that seek to appropriately enhance scientific exchange. They are committed to providing access to anonymized patient data and full Clinical Study Reports (CSRs) from their clinical trials to qualified scientific researchers. They are supportive of the European Federation of Pharmaceutical Industries & Associations (EFPIA) and […]

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Certara’s ClinGenuity Named a “Cool Vendor” in Gartner’s 2015 Life Sciences Report

PRINCETON, NJ – Apr. 30, 2015 – Certara®, the global biosimulation technology-enabled drug development consultancy, today announced that its ClinGenuity company has been named a “Cool Vendor” in Gartner, Inc.’s 2015 Life Sciences report1. ClinGenuity was acquired by Synchrogenix, Certara’s regulatory writing company, in January 2015. “We are delighted that Gartner has recognized us,” said […]

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Synchrogenix & CISCRP Partner to Help Biopharm Companies Meet Clinical Data Transparency Mandates

The Center for Information and Study on Clinical Research Participation (CISCRP) and Synchrogenix, Certara’s regulatory writing consultancy, are collaborating to develop lay summaries of clinical trials for the general public PRINCETON, NJ – April 23, 2015 – Certara®, the global biosimulation technology-enabled drug development consultancy and the nonprofit Center for Information and Study of Clinical […]

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Synchrogenix, Certara’s Regulatory and Medical Writing Consultancy, Acquires ClinGenuity

Deal provides Synchrogenix with proprietary technology, expert staff, and new capabilities to become the dominant player in life science regulatory and medical writing PRINCETON, NJ – Jan. 6, 2015 – Certara®, the global biosimulation technology-enabled drug development and drug safety consulting company, today announced that its regulatory and medical consultancy, Synchrogenix, has acquired ClinGenuity, the […]

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