All posts by Carolyn Malestic

Visit Idem at RAPS Convergence 2017!

Are global user documentation and labeling your responsibility?
Need to get a handle on translated materials?
Come talk to Idem!

Idem Translations is a top-ranked global translation provider countless life science companies have come to rely on for translation expertise and ISO-certified processes that guarantee quality, consistency, and trust.

Why not make an appointment now?

We’ll see you there! Booth 231 #IdemRAPSItUp

Clinicians, do diverse study subjects have access to translated materials?

The following is an interesting post from a LinkedIn connection. Have you built into your study the participation of diverse groups based on race, ethnicity, and gender? Do you have translated documents to support those populations? Many language providers out there claim to provide specialized translations specifically for life science initiatives, yet few fulfill the necessary requirements to pass muster with your Regulatory Affairs team.

Source: Fomat Medical Research     Diverse study subjects require translated materials                                                                          

Hispanic cancer patients rarely participate in clinical trials, but researchers want to tailor a Spanish DVD to help change this. To create a relevant educational tool, Moffitt Cancer Center researchers investigated why awareness of and participation in trials are so low in this population.

Using focus groups with 36 Spanish-speaking cancer survivors from Tampa and Puerto Rico, researchers found that a language barrier, as well as a cultural idea that only doctors, not patients, guide treatment decisions, may help account for low participation rates.

Looking for ways to improve knowledge and participation for Hispanic patients, the researchers used feedback from the focus groups to help develop a Spanish booklet and video to educate and empower patients to participate in treatment decisions.

The study was published online in May by the Journal of Health Communication: International Perspectives.

The 45.5 million Hispanics living in the United States are the nation’s fastest growing ethnic group, and there is a need to develop health care educational materials that target their language and culture. These educational materials should not be merely translated from English, the researchers said, but should be adapted to meet the group’s informational needs in a culturally appropriate way.

Idem Translations Receives ISO 17100 Certification from Leading International Testing Organization

Palo Alto, CA (PRWEB) January 23, 2017

Idem Translations, a provider of translation and localization services for life science companies, has achieved ISO 17100:2015 certification following a comprehensive audit performed by international testing and inspection organization, TÜV SÜD America. ISO 17100 is the globally recognized standard that establishes guidance for critical processes within translation, quality of service, delivery requirements, translator evaluation and selection, technical resource specifications and general management guidelines for translation service providers. ISO 17100:2015 replaces the previous European standard for translation services, EN 15038:2006, thus addressing changes within the industry.

Idem Translations is among the first U.S. translation providers specialized in life science to receive
ISO 17100 certification by TÜV SÜD America. Idem is proud to have successfully passed TÜV SÜD America’s stringent auditing procedures, validating the company’s strict approach for producing superior translated content for its clients.

“Our clients work in regulated industries where safety and traceability are the very foundation of their development and manufacturing processes. They rely on Idem Translations to ensure that translation processes follow the same quality control steps that are both repeatable and auditable,” said Jessica Alexander, Vice President of Quality & Operations at Idem Translations. “Updating our ISO certification to 17100 signals our commitment to continually reduce risk throughout the translation process, and provides a guarantee to clients that translation will be one less thing they’ll have to worry about.”

“Companies like Idem Translations that invest in multiple ISO standards like ISO 9001, ISO 13485 and ISO 17100 recognize the importance of certification not just to clients but to the overall mission of continuous process improvement,” said Dr. Christopher Devine, President of Devine Guidance International. “More than just standards, these certifications mean that the company is focused on meeting tough industry requirements that result in exceptional vendor care.”

Idem will be at RAPS 2016. How about you?

Calling all regulatory professionals!

Idem will be exhibiting at RAPS Convergence in Santa Clara, California, September 17-20. You won’t want to miss this year’s fantastic lineup. If you’re interested in sessions that address updates to regulations and guidance around the globe, this is a perfect opportunity to stop by and speak to us about your future translation needs.

Let’s put our heads together at RAPS and see how we can make translations the easiest part of your job! Schedule a meeting with us today.

We’re giving away a Fitbit, so stop by for your chance to win. See you there!
Booth 135




Crowdfunding – the New Medical Device Mania

Crowdfunding has become a household word among technology companies, and is now making its way to the forefront of the medical device industry. Sites like Kickstarter and Indiegogo are seeing a rise among would-be investors getting in on the ground floor of these ventures, with the promise of blockbuster returns. Certain sites are targeted specifically to the medical device developer community; examples such as Crowdacure aim exclusively on medical device development.
The reasons for this burgeoning activity are essentially the same as what one might find in technology: investor appetite for early-stage development is on the wane since so many of them would prefer to invest in ventures whose devices are closer to market release. This, coupled by the FDA’s perceived inability to move devices more rapidly through regulatory channels results in device manufacturers’ willingness to seek approval with offshore regulatory bodies (particularly the EU). What’s more, researchers and early-stage device manufacturers are trying to rein in costs so as to make their technologies affordable for everyone. Quite often, it’s the only way for companies to fund research and development for non-traditional diseases or conditions that aren’t a target for regular funding pathways, either because the population affected isn’t large enough or vocal enough.
The funding path from unorthodox sources like the ones described is, of course, fraught with risk. A multitude of eager investors may hedge their bets on therapies that will never see the light of day or receive FDA clearance, and there’s no specific language to date that addresses the legal implications of such a practice. Certainly the FDA is in no hurry to make a ruling on how products are financed, limiting its reach to issues that might pose a threat to public safety.
It’s easy to see the attraction for the medical device startups to go this route, and it could be a faster, more economical method for getting much needed therapies out to the public sooner and more affordably. What are your thoughts about this practice? Are you currently involved in or thinking about a crowdfunded approach to funding your medical device development?

The Linguist’s Dilemma

As companies increasingly communicate with stakeholders around the globe, the idiosyncrasies of our languages become an everyday concern. Tagalog, spoken by 2% of the California population and with 100 million speakers worldwide, is an interesting case. Native to the Philippines, the Tagalog language has been heavily influenced by both Spanish and English as a result of colonial occupation by Spain and the United States from the 16th to the 20th centuries.

A guest post from one of Idem’s Tagalog translators illustrates some of the language’s quirks:

A few years ago, a translation agency invited me to participate in the Tagalog translation of a survey. Tagalog was to be one of twelve different languages for the final survey and the completed translations were sent to a Tagalog focus group for review. The comments from the focus group were sent back to me and I updated the translation accordingly. This version was sent to a second focus group…and I received a second round of suggested changes. Each time I made cosmetic changes, the translation was sent on to yet another focus group who, without fail, would return a new set of comments for further editing. Finally, long after the other eleven languages were complete, the translation agency called to say that they were putting a stop to the Tagalog edits, which had become far too costly and time-consuming for the end client. We never got to a version that all Tagalog speakers could agree upon.

There are always issues like this with any Tagalog translation because Tagalog doesn’t quite have codified rules of grammar that Tagalog speakers can agree on. The language is spoken in so many different provinces, each one with its own distinct regionalisms, making it virtually impossible to standardize a single set of grammatical norms. Language elasticity is a uniquely cultural phenomenon in the Philippines.

Ever since the US Census Bureau added “language spoken at home” as a checkbox item on its census reports, there has been an increasing trend to translate words and concepts into Tagalog. The truth is that 99.9% of the Tagalog-speaking population does not speak or read pure Tagalog, rather a mixture of Tagalog and English. Taglish, a mix of Tagalog and English, better reflects the everyday language that we speak and write.

It is by no means unusual to see English words liberally used in a Tagalog text. Case in point: below is an excerpt from an article that appeared in an online Tagalog newspaper:

Kung totoo ito, lumilitaw na binabastos ang Republic Act 10643 na nag-uutos lagyan ng graphic health warnings ang mga kaha ng sigarilyo. Pinirmahan ang RA 10643 noong nakaraang taon ni President Noynoy Aquino. Kabilang sa mga ipi-print sa mga kaha ay ang mga retrato ng sakit na nakukuha sa paninigarilyo gaya ng cancer sa baga, lalamunan, bibig, pisngi, dila at ang sakit na emphysema, katarata at sakit sa puso. Bukod sa mga retrato ng sakit, obligado rin ang mga cigarette companies na ilagay ang mga mensahe na nagpapaalala na masama sa kalusugan ang paninigarilyo. Sa kasalukuyan, maliit na mensahe lamang ang nakalagay sa bawat kaha ng sigarilyo na halos hindi mabasa. Layunin ng paglalagay ng mga retrato ng sakit sa mga kaha na mapigilan ang mga naninigarilyo at mga nagbabalak pa lamang. Inaasahang marami ang magdadalawang-isip na manigarilyo kapag nakita ang mga retrato ng sakit.

Other curiosities exist in our language. Colors like green and blue are left untranslated, which is deliberate, as Filipinos would normally say those in English. The Spanish language has given us many loan words such as retrato for “photo,” whereas the direct Tagalog word is spelled as litrato. Words like mesa, kandila, puerta, puede, and others exist in everyday use, because the Spaniards were in the Philippines for 400 years and left their mark on the language.

The world is getting smaller. In Tagalog, a mere sentence bears witness to the movement of peoples over the past 500 years, from the base Filipino language through Spanish rule and American control.

Join us at the ACRP Meeting & Expo 2016 April 16-19 in Atlanta

Idem will be among this year’s exhibitors at the 2016 Association of Clinical Research Professionals (ACRP) Conference in beautiful Atlanta, GA.

ACRP is the largest national conference whose sole focus is on clinical trials, with more than 100 sessions covering myriad topics related to the clinical trials process. Attendees and exhibitors from around the country will be on site to learn more about new and existing trends, upcoming changes and challenges in clinical research.

If your trials have an international component requiring non-English content, come see us at booth #538A in the Exhibit Hall.

And just for fun, Idem will be holding an entertaining contest right there at the booth – more details at the show!


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