Language Scientific and Ethical GmbH Announce Partnership for Translation of Endpoint Adjudication Software
Language Scientific is proud to announce a new partnership with Switzerland based Ethical GmbH for translation services, enabling sponsors and clinical research organizations to manage endpoint adjudication alongside translation of event documentation within an integrated cloud solution.
Medford, MA March 23, 2016
Language Scientific, Inc., the leading clinical translation company, is pleased to announce a new innovative partnership with Ethical GmbH, the premier independent provider of Endpoint Adjudication Software Services. The partnership will enable sponsors and clinical research organizations conducting multicenter global clinical trials to manage endpoint adjudication together with the translation of event documentation in one integrated cloud solution.
Clinical endpoints assessment and adjudication is crucial for reducing patients’ risks and biases related to multi-center studies with subjective or image-based endpoints. The Ethical eAdjudication ® software provides the study staff a centralized online repository to manage the event information and to track the assessments procedures in a GxP environment. But in many cases event documentation is only available in languages other than English or in a mix of languages, and needs to be translated before it the endpoint can be properly assessed by all members of the Clinical Endpoint Committee. Now study staff can request translation, track different stages of the translation process in real time, receive delivery status, and monitor translation costs all within Ethical eAdjudication ® solution. By integrating the adjudication and translation processes clients reduce costs, speed up the process, and mitigate the possibility of misidentifying or misfiling translations.
Ethical GmbH selected Language Scientific as its translation partner because of their deep experience and highest quality reputation in clinical translation. Language Scientific has over 15 years of experience providing clinical translation services to customers such as Amgen, Cubist Pharmaceuticals (Merck), Eli Lilly, Intercept Pharmaceuticals, Novo Nordisk and Roche. They specialize in high quality expedited translation of Adverse Event and case source documents. Often these types of documents contain illegible handwritten notes by physicians, and have highly specialized vocabulary targeted at other clinicians. Language Scientific employs translators who are M.D.s expert at translating materials written by other doctors and working with documents that may be either poorly scanned or handwritten. Throughout the translation process, Language Scientific takes these handwritten or typed clinical documents and recreates them in an electronic format. To meet regulatory compliance an additional service of redacting patient identifying information from source documents is also completed during the translation stage.
“At Language Scientific, we have developed unique partnerships with Clinical Research Organizations, that have enabled us to create a successful Endpoint Adjudication translations practice” says LS CEO Sharon Blank. “We are able to leverage our native speaking medical professional linguists to provide the highest quality translation for our clinical partners. I believe we are in an excellent position to provide great value to Ethical GmbH and their customers.”
“Due to the gravity of consequence of an incorrect translation in a clinical trial, I am thrilled to be able to offer our clients the services of a highly specialized company such as Language Scientific, that puts the high quality of their translations first and foremost” says Mimmo Garibbo Director at Ethical GmbH. “We understand the importance of tracking every stage during the Endpoint Adjudication process and this partnership will make tracking translation easier than ever before.”
Stop by Language Scientific’s Booth at the upcoming 2nd Annual Endpoint Adjudication Conference in Philadelphia, May 4-5 2016 to learn more about how Ethical GmbH and Language Scientific are working together.
About Language Scientific, Inc. ®
Language Scientific, Inc. is a US-based globalization company specializing in clinical, medical, scientific and technical language services and solutions with a record of more than 20 years of excellence in all the European, Asian, Middle Eastern, African and American languages. Language Scientific serves more than 1,500 clients in the pharmaceutical, clinical, and medical device industries, from Fortune 500 companies to small emerging companies. Our specialization, focus, innovation and customer-centered attitude have earned us the trust of many of the world’s best life sciences companies. For more information, visit: https://www.languagescientific.com or email: info(at)languagescientific(dot)com.
United States: Medford, MA (Corporate Headquarters) | Los Angeles, CA
Europe: London, United Kingdom
Asia: Chongqing, China | Shanghai, China
ISO 9001: 2008
EN 15038: 2006
About Ethical GmbH and eAdjudication ®
Ethical is a company, based in Basel Switzerland, providing eClinical Software and Services. Main solutions offered by Ethical include eAdjudication ® for Clinical Endpoint Adjudication and e-CRF ® for Electronic Data Capture and Clinical Data Management.
The eAdjudication ® Software Platform is provided as a cloud service including the hosting, technical management, validation (CSV / 21 CFR Part 11 compliance), training & day-to-day technical support.