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Life Sciences

Clinical trials

For many years now, Telelingua has been the preferred partner for a large number of clinical research organisations (CRO). Our expertise and certified procedures enable them to ensure the high levels of quality and responsiveness that they pledge to their own clients (sponsors), with translations into more than 50 target languages (Europe, Asia, Africa, South America).

At each step of phases I, II and III, communication with stakeholders, such as Ministries of Health, Ethics Committees and Regulatory Affairs departments, involves observing rules and strict deadlines to guarantee the smooth progress of the trials.

Among the many clinical trial-related documents we translate daily are most notably informed consent forms (ICF), patient information sheets (PIS), clinical trial protocols (CTP), protocol synopses, case report forms (CRF), questionnaires, analyzes, consent withdrawals, investigator’s brochures (IB) and bids for clinical trials.

Back translations and third-party revisions

In order to satisfy the regulatory demands of our clients, we provide the services of back translations and third-party revisions.

Back translations involve translating a text from the target language into the source language again. Then, by comparing the back translation to the original source text, it is possible to verify that the target translation effectively transmits the message of the original text. Telelingua offers effective management of the revision process using back translations and guarantees that the final product corresponds with the intended meaning.

In the case of third-party revisions, after all of the translation, revision and quality control stages have been completed, an independent translator compares the translation with the source text in order to verify that it is complete and accurate.

Medical devices

Manufacturers of medical devices are confronted with critical requirements in relation to their translation needs. In fact, a translation provided as part of a low quality process can compromise patient safety, undermine the reputation of the company and cause serious difficulties.
Owing to many years’ professional experience with manufacturers of medical devices, Telelingua has an approach which responds to the international regulatory demands in terms of responsibility, accuracy and verifiability. Under the management of experienced senior project managers, Telelingua provides made-to-measure translation services to respond to the needs of its clients working in the field of medical devices.Contact us to discover how we can help to reduce your costs while also improving the quality of your multilingual documentation. There are no ready-made solutions, but we can work with you to create tailored workflows that draw exclusively on the tools which best satisfy your requirements. Telelingua possesses a wealth of experience in medical translation, from clinical trials to pharmaceutical patents, including instruction manuals and installation manuals for medical devices. Whatever your request, we can show you a better approach to translation.

Online project monitoring and archiving

Telelingua has a very good understanding of the fact that the life sciences industry operates at a rapid pace and that a single day’s delay can lead to significant commercial losses or to failures in achieving regulatory approval. This is why we take the initiative by means of regular reporting and have developed a project management portal which gives clients a transparent vision of the translation process at the project level.

Thanks to this secure online project management portal, our clients can follow the status of projects in real time, at any time of their choosing, via the same user-friendly interface that our project managers use. From the uploading of files to the questions posed by translators and revisers, everything is recorded and clearly documented. All of this remains accessible for verification purposes, even when the project has ended. An archive which conforms to ISO standards is also available.

Telelingua can also lay claim to several industrial standards and proprietary software tools to guarantee that our translations conform with the terminology and the style guides specified by the client. Any incoherence is checked in person by a reviser and with the use of sophisticated linguistic tools. This allows us to maintain an unrivalled level of coherence, homogeneity and accuracy.

Back translations and third-party revisions

In order to satisfy the regulatory demands of our clients, we provide the services of back translations and third-party revisions.

Back translations involve translating a text from the target language into the source language again. Then, by comparing the back translation to the original source text, it is possible to verify that the target translation effectively transmits the message of the original text. Telelingua offers effective management of the revision process using back translations and guarantees that the final product corresponds with the intended meaning.

In the case of third-party revisions, after all of the translation, revision and quality control stages have been completed, an independent translator compares the translation with the source text in order to verify that it is complete and accurate.

Linguistic collaboration tools

Telelingua works to provide you with a solution which can be integrated into your workflow and uses your existing linguistic resources to ensure that the final translations are as accurate as possible and that they satisfy any local requirements. We can work hand in hand with your local validators, for instance foreign subsidiaries, partners or distributors, in order to guarantee that all translations are reviewed and that all changes are approved before the final delivery.

We can also collaborate with your local resources to create approved glossaries. This enables an increase in accuracy and a reduction in the costs and time taken for the quality control phase. 

In addition, the terminology database can be made accessible online, in a secure manner, to allow your local partners and other experts in the field to consult or modify it. Any changes that are proposed are identified and monitored before being entered. This step protects the database from detrimental changes and provides a checkable record of all the changes made.

Pharmaceuticals

When Telelingua began operations more than 25 years ago, our first clients included several companies in the medical and pharmaceutical sectors. In other words, these are two of our core competencies!

On a daily basis, we translate clinical studies, protocols, observation notes, patient information leaflets, scientific and product notices, product brochures, scientific articles, training material, documentation, newsletters, rapid reference guides, etc. for major international groups. We have 25 years’ experience and a network of translators who are experts in this field. Meticulous attention and compliance with accepted norms are also part of our standard procedures.

Key factors behind our success

  • Dedicated teams: project managers, back-up PMs, translators and editors.
  • Implementation of individually tailored procedures in accordance with sector standards.
  • Ongoing program to recruit and evaluate specialist translators, many of whom have a scientific background.
  • Efficient internal ERP system which provides access to the relevant information at any time, enabling a quick reaction.
  • Confidentiality agreements.
  • Efficient file management + communication portal (workflow + accessibility).
  • Translators identified for each document + codification of files + translation of certificates (traceability).
  • Validation and management of feedback with local validators.
  • Meticulous process management.
  • Individually tailored style guides and terminology management (Quality Control).
  • Development of a “Quick Reference Guide” and “Best Practices” for training and harmonizing procedures for all those concerned.
  • Management of feedback and revisions (Quality assurance).
  • Reporting: monthly reports, comparative activity/budget reports, status for each country, study, document and language.
  • Permanent Monitoring and Evaluation (M&E) process (meetings, conference calls, etc.).
  • Secure IT infrastructure.

On an ever increasing basis, we are presented with material for translation in a variety of native file formats. From design applications such as FrameMaker, QuarkXPress and InDesign, or text extractions from a CMS or LMS (Learning Management System) into XML or XLIFF, to software content resident in .NET assemblies, Java properties files and various other resource files; our expertise covers a wide range of content. To guarantee that each language version fully corresponds to the original formats, whether they are to be supplied ready for use or to be imported and reintegrated into your CMS, our desktop publishing specialists along with our localization engineers and IT technicians provide a high level of quality and customer service to save you time.