Apr 06, 2018
Those involved in conducting multi-center clinical trials know that managing Adverse Event (AE) reports received from global trial sites can be very problematic, especially when the reports are in a different language, include handwritten notes and are received in faint scanned and faxed format. As one clinical trial safety manager told us,
“One of the biggest pain points is that the system is too often entirely managed through email and there is always a mad rush to get all the AEs translated quickly.”
In close collaboration with our clients’ clinical trial organizations OmniLingua developed a web-based Adverse Event document management and localization solution that meets regulatory and business requirements and ensures high translation quality. Incorporating principles of Good Clinical and Documentation Practice our team of Life Science localization experts set up standard AE report project specifications and workflows that include:
- File naming conventions
- Duplication confirmation
- Redaction of protected health information
Use of a controlled formatting template locks down document ID components and reuses source formatting to reduce cost. Based on these user requirements our in-house software team then created a web-based portal that allows global 24/7 project submission and will document all project activity, including:
- File transfer
- Project approvals
- Management of the change request process
This solution also integrates financial aspects of project management (approval of quotes, review and approval of invoices) to reduce non-essential emails and create a central repository for commercial records. In the words of a Medical Safety Program Manager who frequently uses this solution,
“The Portal is user-friendly and logically organized. Having the ability to see the various statuses of my projects along the way is helpful and the ability to add notes as a communication tool is a feature of the system that is nice, since all information for a project is stored in one central location. I wish other systems were as easy to use.”
All of these hard-wired processes and automations are only part of the story, though. The assignment of linguists specialized in clinical study documentation, trained on the therapeutic area, and specific study scope & objective are absolutely essential.
“Omnilingua expects meticulous preparation for clinical study translations. They believe translators can only produce top quality if they are properly acquainted with all the particularities of each individual study in advance. I really appreciate this methodological approach.”
OmniLingua’s clinical portal for Adverse Event reports has been tried, tested and continuously improved in more than 25 multi-center trials over the past 8 years. It has been audited by our clients and has passed their corporate compliance and industry data security standards. Turnaround times for translated Adverse Event reports have been reduced significantly and the portal’s audit trails have simplified client-side audits.
Use of OmniLingua’s clinical portal for Adverse Event reporting is free of charge for our clients. Contact us today for more information and a demo.Read More
Feb 20, 2018
As the new year gathers speed and we are pulled into the fast-paced flow of 2018 here are some trends that we feel will impact translation buyers and the localization industry in 2018.
Size Matters - Localization Industry Changes
The past tidal wave of mergers and acquisitions will continue as large technology companies like Apple and Google extend their activity further into the localization arena. As global markets continue to expand exponentially and client-side localization systems become increasingly mature corporate translation buyers are looking for larger localization partners with a wide range of capabilities and expanded global footprint.
Translation Tools and Technology
As speed to market continues to be a primary driver of innovation in the localization industry, automation and technology are a primary focus. Neural MT is quickly moving from “early adopter” to mainstream status and post-editing tools driven by Artificial Intelligence (AI) and machine learning will support acceptance by linguists. Computer-Assisted Translation (CAT) tools are quickly incorporating Adaptive Machine Translation with more granular match suggestions. This introduces more post-editing into the standard translation process, reducing costs and allowing translators to work faster. Text-to-speech, voice recognition and automated interpreting solutions will revolutionize localized audio output.
Digital Content Rules!
The demand for localization of digital content will continue to increase at a rapid speed. Dynamic website and social media content will require localization into an increasing number of local languages. This includes multilingual videos, eLearning content and localized apps.
Language Requirements are in Flux
Translation buyers should see an increase in the selection of supported languages in 2018. The increased localization of apps and digital content means a greater focus on smaller local markets in Africa and Asia with more customized translation or transcreation. Regulatory changes in Europe will impact most medical device companies as they prepare for the new EU medical device regulations (MDR and IVDR) taking effect in 2020: this requires that labeling, packaging, and instructions for use be translated into a potential total of 32 standard languages. Geopolitical changes are also impacting language in 2018, as seen in Kazakhstan, where Cyrillic script is being replaced by the Latin alphabet to distance the country from Russia.
How Can OminLingua help?
OmniLingua’s recent acquisition by Ingenuiti increases our size, expands our capabilities in eLearning and software development and extends our global reach with Asian operations. Our new internal software development team allows us to respond to your needs more quickly with specialized automated solutions, such as our tools for multimedia and responsive content reviews (desktop, tablet, mobile) and our clinical trial portal specialized for medical safety reports. We interact regularly with our pool of long-term linguists, providing information and training to ensure they stay up-to-date with the newest MT and translation tool developments: even our teams of Xhosa, Zulu and Sesotho translators are using the newest tools to localize clinical study apps.
We look forward to talking with you about your localization challenges in 2018!Read More
Nov 15, 2017
Category: Press Releases
Ingenuiti, a leading translation and multimedia services provider in the eLearning industry, has announced the acquisition of OmniLingua Worldwide, LLC of Cedar Rapids, Iowa.
Under the terms of the purchase – effective as of Oct. 31 – the acquired business will continue to operate under the name “OmniLingua Worldwide” as a division of Ingenuiti.
The acquisition will allow Ingenuiti, headquartered in Virginia Beach, Va., to expand its core competencies by leveraging OmniLingua’s expertise in localization services.
OmniLingua has provided translation, localization, and technology solutions to major clients in the life sciences, automotive, heavy equipment, and manufacturing industries for nearly four decades. It has a long-tenured staff and worldwide network of linguistic partners who will continue to provide professional translation services to the combined client base.
“Ingenuiti specializes in providing engaging turnkey learning solutions from conception and development to translation and global deployment. The addition of the OmniLingua team to our company essentially doubles our strengths and will enable us to leverage their translation and localization expertise to better serve our existing clients and further expand our business,” said Maarten Fleurke, CEO of Ingenuiti.
Ingenuiti was founded in 1996 with an emphasis on supporting corporate globalization efforts. After becoming established as the most specialized localization company in the area of eLearning translation, the company started supporting corporations and NGOs with their eLearning development needs.
In addition to its Virginia Beach headquarters, Ingenuiti also has locations in Charleston, S.C., Dumaguete City and Cebu City in the Philippines, and Shenzhen, China. As part of this acquisition, OmniLingua’s Cedar Rapids, Iowa, office will remain in operation.Read More