Executive Brief: Best Practices for Doc Localization

Good translation isn’t cheap, but translation mistakes are even more costly. How do you reduce the risk of error? First, learn how translation providers operate. Then, manage your document localization process according to industry best practices. Here at Idem, we believe that a little knowledge goes a long way. So we have put together the top five best practices for document translation that will help you protect your patients and your bottom line.

Ready to get started? Download the brief!

Idem to Sponsor the 2015 ACRP Conference in Salt Lake

Idem is proud to announce our sponsorship of the 2015 ACRP Global Conference & Exhibition.  This year’s ACRP conference will take place April 25-28 in beautiful Salt Lake City, Utah.  We are looking forward to the new, roundtable format that promises to encourage discussion and learning.  Do your clinical trials have an international component?  Do you recruit non-English-speaking subjects?   We would love to see you at booth #621 in the Exhibit Hall!

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Idem Translations Sponsors the RAPS 2014 Conference

Idem Translations is proud to sponsor the RAPS – 2014 Regulatory Convergence taking place in Austin, TX from Sept 27 to Oct 1. 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 231.

Idem to participate in the 2014 LocWorld Life Sciences Roundtable in Dublin June 3-6th

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:

Executive Summary of the Intelligent Content for Life Sciences Conference

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.

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Idem Translations will attend the 10x Medical Device Conference May 12-14, 2014 in Minneapolis, MN.

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 attend the DIA Global Labeling 2014 Conference in Bethesda, MD April 9-10th.

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.

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Idem Translations attended the ASCPT Conference March 18-22, 2014 in Atlanta, GA

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.

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Idem receives recognition for NCC ACRP Sponsorship

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 selected as a key translation provider for Quorum Review

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