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. This approach starts with the initial drafting of regulatory documents and continues all the way through publication of regulatory documents under the European Medicines Agency’s (EMA) Policy 70 (http://www.ema.europa.eu/docs/en_GB/document_library/Other/2014/10/WC500174796.pdf).
Synchrogenix’s Artificial Intelligence (AI)-enabled redaction service is the industry-leading solution that generates anonymized data transparency documents, allowing the clinical and drug development market to follow Policy 70 rules quickly and efficiently. In the winter of 2016, PleaseTech will roll out a new release of its industry-leading PleaseReview software that will provide an additional ability to review and apply redactions. Synchrogenix’s AI technology automatically applies contextual rule-based redactions, and the new release of PleaseReview will allow sponsors to review those documents directly using the best-in-class, real-time co-authoring capabilities provided by PleaseReview.
“PleaseReview has been a trusted tool that Synchrogenix writers have used to expedite and mediate the regulatory document review process since 2008. We are thrilled to continue working with PleaseReview within the redaction paradigm to bring a streamlined and efficient process to the market,” said Kelley Kendle, president of Synchrogenix.
“Faced with the challenges the EMA transparency policies bring, providing a complete redaction solution is the logical step to ensure customers have the right technology at hand,” added David Cornwell, PleaseTech CEO.
PleaseReview provides a unique, browser-based environment for the secure, controlled, and collaborative review and co-authoring of Microsoft Word documents, PDF documents, and other documents types. It works by enabling simultaneous review and co-authoring by multiple participants, wherever they are. Review owners can decide which changes to accept or reject, and all accepted changes and comments are automatically incorporated into the document, making copying and pasting a thing of the past. In addition, all activity during the review is captured in a comprehensive report for quality assurance, audit, and other business purposes. For more information, visit www.pleasetech.com.
Certara is a leading decision support technology and consulting organization committed to optimizing drug development and improving health outcomes. Certara’s solutions, which span drug discovery through patient care, use the most scientifically-advanced modeling and simulation technologies and regulatory strategies to increase the probability of regulatory and commercial success. Its clients include hundreds of global biopharmaceutical companies, leading academic institutions, and key regulatory agencies.
Ellen Leinfuss, 609-216-9586
Chief Marketing Officer
Lisa Osborne, 206-992-5245
Rana Healthcare Solutions