In the world of translation and localization, the life sciences sector is different from any other industry because of the unique and specific nature of its requirements. With regulations changing on a continual basis, a premium is placed on quality above all else. For our Life Sciences Business Round Table in Dublin, we are delighted to offer a stellar one-and-a-half day program with a particular focus on the challenges of medical device localization. Life sciences professionals, clients and vendors will be presenting and sharing their thoughts and experiences on specific processes as well as the variety of requirements and challenges at work in the life sciences industry today. Click image below for conference details:
Idem’s VP of Quality & Operations, Jessica Alexander, attended the Intelligent Content Conference for Life Sciences and Healthcare May 8‐9, 2014 in San Francisco, California. The conference focused on how professionals in the medical device, pharmaceutical, and healthcare fields can take advantage of advances in content management processes to improve their own content, improve the user experience for their customer base, and reduce translation and localization costs. For a summary of conference highlights please click on the image below.
Idem Translations will be attending the 2014 Medical Device 10X Conference – An event focused on growth strategies for Medical Device companies. Topics will include:
• What European Reg Changes Mean For Your Business
• Leading Causes of Success or Failure in a Medical Device Start Up
• A Regulatory Primer for MedDev Manufacturing and Operations
• Development Considerations Taken By Successful MedDev Startups
• Extractables and Leachables Testing for Medical Devices
Idem Translations will be attending the 2014 Global Labeling Conference April 9-10th where regulators and industry representatives will discuss the impact of recent global labeling guidelines and regulations including:
• EU global pharmacovigilance guidelines
• Draft and new FDA guidances
• Plain language initiative in Canada
• Risk management regulations in Japan
• Other emerging labeling guidances (Canada, European Union, Japan, US)
For more information, click on the image below.
Idem participated in the annual conference for the American Society for Clinical Pharmacology and Therapeutics March 18-22, 2014. The event was held in Atlanta, GA. Over 1,100 scientists, clinicians and educators attended this meeting in 2014 to learn, connect, and network. This meeting is the preferred clinical pharmacology and therapeutics conference.
Idem receives recognition from The Northern California Chapter of the Association of Clinical Research Professionals (NCC ACRP) for the sponsorship of the education event, Medical Device Trails – What We Need to Know about Audits and Inspections. The event was a great success with over 85 attendees who gathered a lot of information from the speaker Karen Bielinski from CARA-Consulting LLC. “These events are a valuable service to the clinical trial professionals and the communities we serve. Without Idem as a sponsor, we would not be able to provide this service.” – Kathryn Howard, NCC ACRP
Pictured below – Mariam Nayiny, Idem President; Bonnie Miller, NCC ACRP President; Marygrace Barasi, Idem Sr. Project Manager
Idem Translations, a leading provider of translation services to the Life Sciences industry, announced their selection as a key translation partner for Quorum Review IRB.
This partnership is not only an honor but also a significant benefit for Idem clients who use Quorum Review’s services. As an approved vendor, Quorum accepts translations certified by Idem without any further cost or review.
Idem is proud to now be counted among this elite list of accepted vendors. It is a testament to the consistent quality of their work and the superb service provided. More importantly, Idem recognizes the great value that this has for clients!
About Quorum Review
Quorum Review is an independent ethics review board that is fully accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP) and has been providing ethics review of drug and device trials since 1992. Quorum oversees research in accordance with U.S. and Canadian human research subject protection regulations, guidelines set forth by the International Committee on Harmonisation (ICH), and principles of the Belmont Report.
Quorum’s best-in-class service and support includes 3 protocol board meetings a week, daily amendment board meetings, 24 hour site review, 36 hour amendment review, and a secure OnQ™ web portal for online submissions, downloads and submission status review. Quorum can review studies in the US and Canada, review federally funded studies and has a specially designated Phase I study management team.
For information about Quorum Review services: www.quorumreview.com
Idem Translations will participate in the 2013 Life Sciences Roundtable taking place at the LocWorld conference taking place in Silicon Valley on Oct 8th and 9th. In the world of translation, the life sciences sector is different from any other industry because of the unique nature of its requirements. With regulations changing on a continual basis, a premium is placed on quality above all else. The Life Sciences Business Round Table offers a program focused specifically on the challenges of life sciences localization. Subject matter professionals, clients and vendors will be presenting and sharing their thoughts and experiences on specific processes as well as the variety of requirements and challenges at work in the life sciences industry today.
Idem Translations is proud to sponsor the RAPS – 2013 Regulatory Convergence taking place in Boston, MA from Sept 28 to Oct 2. This event gathers regulatory professionals who work in medical device, pharmaceutical, and biotechnology sections. In addition to working with submission and compliance, these regulatory professionals play integral roles in all stages of the health care product lifecycle from development to marketing and post-market surveillance. This event’s intensive workshops, educational sessions and networking events come together in a program designed by regulatory experts who understand the challenges and opportunities faced by today’s regulatory professionals. We look forward to seeing you at our booth – number 2005.
Firm follows the best practices model designed exclusively for the translation industry
Palo Alto, California, January 29, 2013 – Idem Translations, Inc., a full-service provider of translation and localization services, has achieved EN 15038:2006 certification from TÜV SÜD America Inc., a worldwide certification body for quality management systems. The company’s quality management system is additionally certified to the ISO 9001:2008 and ISO 13485:2003 international standards.
This achievement makes Idem Translations one of a select group of language service providers to hold all three industry certifications for the translation of life sciences materials.
EN 15038:2006 was developed by the European Committee for Standards (CEN) to establish and define the requirements for the provision of quality services by translation service providers. The standard encompasses the core translation process, including commissioning, translation, proofreading, review, project management, quality control, traceability, and delivery. It helps describe and define the entire service and offers a set of best practices for all aspects of the translation and localization process.
Idem provides expert translations of all types of documentation related to research and development, clinical trials, FDA and CE Mark submissions, international marketing, and ongoing patient care.
“The best practices outlined in EN 15038 set the industry standard for the highest quality language services,” said Mariam Nayiny, president of Idem Translations, Inc. “Idem’s certification to this standard confirms that our audited procedures are designed to consistently produce the quality results expected by our life sciences clientele.”
“Achieving EN 15038 certification demonstrates that a translation service provider has successfully implemented the processes considered necessary to ensure quality translation, including traceability of linguistic resources and the specialized professional competencies required of translators,” said Charles Clark, technical product development manager, Management Services of TÜV SÜD America Inc.