Translate your content using specialist medical linguists. Below is a quick overview of Idem’s services for companies in the medical device and pharmaceutical industries. We offer comprehensive translation services, including back translation, reconciliation, linguistic review, quality assurance, DTP and more.
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?
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.
You know your translation provider is doing a great job. But how can you demonstrate quality compliance to your regulatory auditor? By preparing to answer her questions before the audit, of course!
Let us share our tips and tricks for tackling your auditor’s translation-related questions. We even include a pre-audit checklist.
Reduce your audit stress: Download the brief!
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!
An ongoing sponsor of the Northern California Chapter of the Association of Clinical Research Professionals, Idem was proud to support the NCC ACRP‘s 2016 planning meeting. The NCC ACRP seeks to provide opportunities for professional development and networking to clinical professionals in the California Bay Area and Sacramento.
Idem has committed to sponsoring the NCC ACRP in order to support our colleagues working on the front lines of clinical research. It is our immense pleasure to provide translations that assist in their efforts.
Do you feel that your in-country reviewers and your translation provider just aren’t on the same page? Is the disconnect costing you time and money? If you think it shouldn’t be this hard, you’re absolutely right.
Don’t get stuck between the good intentions on both sides! Instead, plan your review process in advance and avoid the top five pitfalls that derail translation timelines.
Ready to transition in-country review to a straightforward validation process? Download the brief!
We had a wonderful time at this year’s client appreciation cocktail party, which took place on the 4th of November at Palo Alto’s University Club. Some 120 guests enjoyed wine, nibbles (the miniature street tacos were a favorite), and fun party games. Top prize winners took home a Fitbit and two Caran d’Ache pens.
Thank you to everyone who attended and to all the partners who continue to help Idem grow!
Following the release earlier this year of the FDA’s draft guidance on the use of electronic informed consent in clinical investigations, several of our clients are actively working to improve the patient recruitment process for clinical trials. Some are transitioning to an eConsent process. Others are streamlining the ways that potential participants receive recruitment information.
Idem is excited to attend this month’s ClinPulse panel, which is focused on:
• How will eConsent affect the patient experience?
• How will it streamline clinical trials?
• What will become best practices?
• What regulatory requirements are in place or coming down the pike?
We hope to see you there!
You know that your translation vendor is using Translation Memory. But how does it work? And what can you do to maximize your savings?
You don’t need to be a tech geek to understand our tips for effectively managing your translation memory assets. Just a little knowledge will help you cut costs and reduce your translation timelines.
Ready to save some $$$? Download the brief!