LIFE SCIENCES

LIFE SCIENCES

"I really appreciate your work and I can say that whenever I ask for your assistance I always receive the best service I can ask for.

When I started working on this study I had some special requests regarding the footers and the CoT’s. I felt that you were very precise and did your best in order to fulfill them.

It’s a great pleasure to know that I can count on your great work. I always know that my files are in safe hands.  Thank you."

 

Senior Project Manager, Contract Research Organization, Princeton, USA

Global Quality Certifications

  • ISO 9001 certification
  • ISO 17100 certification (translation-specific)
  • Certified SAP Partner
  • SAP Automation Ideas Award 2017
  • SAP Translation Partner of the Year 2005

Download our brochure Focus on Life Sciences Translations

Our clients in the Life Sciences industries include Healthcare, Pharmaceutical companies and Laboratories, Contract Research Organizations (CROs), Medical and Surgical Device Manufacturers, Biotechnology companies, as well as Patient Recruitment organizations, Health authorities, Medical information & publishing companies, and Animal Health companies. Our work with Life Sciences companies represents more than 40% of our turnover.

Healthcare, Pharmaceutical Companies and Laboratories

Pharmaceutical companies face many challenges today: compliance with regulations, and ever-increasing requirements for quality, integrity, traceability, and patient safety, as well as business performance challenges such as increasing their global market share. Introducing new or improved drugs into global markets requires the provision of appropriate translated materials. Yet, translation is not typically an activity that falls within the core competency of pharmaceutical companies. That is why they turn to Telelingua. Whether we are focusing on PILs, PROs or ICFs, we understand that the accuracy of translations can have a direct effect on patients’ well-being, and the successful treatment of illnesses. Thanks to our knowledge of pharmaceutical markets and our experience with regulatory submissions, we can help global pharmaceutical companies achieve their goals.

Contract Research Organizations (CROs)

As drugs are constantly being developed or improved, Life Sciences companies (sponsors) turn to CROs to accelerate the clinical research process and trials, and to carry out studies in target markets worldwide. In turn, CROs enlist Telelingua’s support and assistance as a preferred translation partner to help them manage the multilingual aspects of their complex assignments. Telelingua performs clinical research and clinical trial translations across all stages of the product development and registration process, including clinical research, phases 0 - IV of clinical trials, surveys, drug testing, regulatory approval dossiers, registration submission and review, production and marketing. At each phase, communication with stakeholders, such as Ministries of Health, Ethics Committees and Regulatory Affairs departments, requires compliance with rules and adherence to strict deadlines to guarantee the smooth progress of the trials.

Medical and Surgical Device Manufacturers

When a medical device reaches the end user, regardless of whether it is for professional or patient use, it has to be accompanied by IFUs, labels/packaging and other critical documentation in the required national language. The user must be provided with the means to understand how to use your device. However, medical device translation should not be regarded purely as a requirement: it is also an opportunity to promote the proper use of your device, demonstrate your dedication to a local market, and reduce your exposure to liability lawsuits. Telelingua’s approach addresses these regulatory demands and meets the standards set by the country in which your products are to be marketed. Our linguistic experts are experienced in translating documents for specific audiences such as biomedical engineers, sales personnel, government regulators, and caregivers. We translate IFUs, DFUs, and maintenance & user manuals for areas including diagnostic equipment, surgical instruments and techniques, orthopedics, hospital equipment, image processing, radiology and radiography, monitoring systems, etc.

Content and Document Types

For our Life Sciences customers, we typically translate the following types of text:

Text genres Examples Target audience
Patient Facing Materials ICF, PIS, PAC, PROs & ePROs, PIL, Patient Questionnaires and Diaries Patients of all ages
Drug Safety and Pharmacovigilance Documents SAEs/SUSARs, DSURs, PSURs, CIOMS Forms, CRFs & eCRFs, ... Healthcare professionals
Clinical Trial documents Protocols, Synopses, IBs, ... Healthcare professionals
EC-RA correspondence MoH letters, EC and CEC approval letters... Ethic Committees, healthcare professionals
Legal, financial and insurance documents Investigator/Institution contracts, Budgets, Patent applications... Institutions and investigators
Medical device documents IFUs, DFUs, maintenance & operator’s manuals,... Biomedical engineers, sales personnel, government regulators, and caregivers
Production requirement documents and SOPs Quality Policy, Quality Manual, Site Master File, Validation Master Plan, SOPs Pharmaceutical manufacturers
Product Labeling Product labels, package inserts, Medication guides Patients and Healthcare professionals
Medical software User interface, test procedures, online help, ... Healthcare industry
Marketing and advertising Web content, advertisements, posters, newsletters, brochures, customer correspondence, ... Patients and Healthcare professionals
Technical Meeting Materials Training manuals, courses and presentations, scientific articles, research papers, Meeting reports Healthcare professionals, investigators, researchers

Therapeutic Areas

(Including but not limited to:) Allergy medication, Cardiology & Vascular Intervention, Cosmetology , Dermatology, Endocrinology, Fertility Medicine, Gastroenterology, Hematology, Immunology, Infectious Diseases, Infection Prevention, Nephrology, Neurology, Obstetrics & Gynecology, Oncology, Ophthalmology, Orthopedics, Pain medication, Pediatrics, Pulmonology, Toxicology, Urology, Vaccines.

Languages translated (to and from English)

Afrikaans (South Africa), Arabic (Israel), Bengali (India), Bulgarian (Bulgaria), Cebuano-Cebu, Cebuano-Davoa (Philippines), Croatian (Croatia), Czech (Czech Republic), Danish (Denmark), Dutch (Belgium, Netherlands), English (Australia, Canada, Ireland, UK, USA), Estonian (Estonia), Finnish (Finland), French (Belgium, Canada, France, Switzerland), Galician (Spain), Georgian (Georgia), German (Austria, Belgium, Germany, Switzerland), Greek (Greece), Gujarati (India), Hebrew (Israel), Hiligaynon (Philippines), Hindi (India), Hungarian (Hungary), Ilokano (Philippines), Indonesian (Indonesia), Italian (Italy, Switzerland), Japanese (Japan), Kannada (India), Korean (Korea), Latvian (Latvia), Lithuanian (Lithuania), Malay (Malaysia, Singapore), Malayalam, Marathi (India), Northern-Sesotho, Southern-Sesotho (South Africa), Norwegian (Norway), Pashto (Afghanistan), Polish (Poland), Portuguese (Brazil, Portugal), Punjabi (India), Romanian (Romania), Russian (Estonia, Latvia, Lithuania, Russia, Ukraine, Israel), Serbian (Cyrillic, Latin) (Serbia), Setswana (South Africa), Simplified Chinese (China, Malaysia, Philippines), Slovak (Slovakia), Slovenian (Slovenia), Spanish (Latin-America, Spain, USA), Swedish (Finland, Sweden), Tagalog (Philippines), Tamil (India, Malaysia, Singapore), Telugu (India), Thai (Thailand), Traditional Chinese (Hong Kong, Taiwan), Turkish (Turkey, Germany), Ukrainian (Ukraine), Urdu (India), Vietnamese (Vietnam), Xhosa, Zulu (South Africa)

Linguists and translation teams

Our Life Sciences department handles 100+ language combinations, including regional variants(*) and dialects, covering many geographic areas: Western Europe; Eastern Europe; Nordic countries; Asia-Pacific; Middle East and Africa; America (North, Central and South America), as well as the emerging markets (BRICS).
(*) e.g. variants of English for UK, USA, Canada, Australia, New Zealand, South Africa, African countries; Indian and African dialects.

Our network of Life Sciences translators consists of around 800 translators who are recruited, selected and approved by our Quality Control Department. Our ongoing recruitment program allows us to respond to translation peaks, adapt our network to market trends, recruit new translators for new or growing language combinations, and set up tailor-made translation pools per country/region or per client.

If necessary, we can also dedicate teams of specialized translators to specific Life Sciences customers. Clients may even request a particular recruitment process, or the creation ofa dedicated team of translators who work almost exclusively on their projects, or need to remain available for these projects only.

Quality Management

Telelingua is ISO 9001-2008 and ISO 17100 certified. We can provide you with a solution that can be integrated into your workflow and uses your existing linguistic resources to ensure that the final translations are as accurate as possible and 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 compile approved glossaries. This helps to increase accuracy and reduce the costs and time taken for the quality control phase. In addition, the terminology database can be made accessible online, on a secure platform, to allow your local partners and other experts in the field to consult or modify it. Any changes proposed are identified and verified before being entered. This step protects the database from detrimental changes and provides a traceable record of all changes made.

Our standard internal review cycle includes:

  • A revision of the translation by a second independent translator, including a check of spelling & grammar, terminological consistency, conceptual/cultural equivalence to the original source version and language adequacy to the target audience.
  • A layout and conformity check (using QA Tools such as QA Distiller or SDL Studio).

Additional services available on request:

  • Validation by Medical Doctors who are licensed in the target countries.
  • Back translations, third-party revisions and validation, if required by the IRB/ethics committee. Depending on the customer’s needs, we offer three scenarios:
 

Confidentiality agreements are signed with our customers, and a Certificate of Translation (CoT) is delivered with every translation.

T-PORTAL:
telelingua's translation track & trace tool

Security

Workflow

Centralization

Flexibility

Traceability

Reporting

User-friendly

Transparency

Time and Cost Management

Customer training

Technology

Translation & Terminology tools

Telelingua uses several industrial standards of terminology databases, translation memory systems (SDL Trados (2007, Studio 2011/2014, WordFast, Déjà Vu, Across), and QA Tools (Studio 2011/2014, QA Distiller, etc.). We can also lay claim to proprietary software tools developed by our in-house engineers to guarantee that our translations comply with customer-specific terminology and style guides.

The use of these tools allows us to:

  • determine exactly what has changed since the last version was published, and translate only the new material
  • ensure terminology coherence, homogeneity and accuracy (translation reuse)
  • provide fast turnarounds and cost-effective translation of updates
  • increase productivity & reactivity

The centralization of translations and the use of translation memories enable cost savings of up to 25%.

Workflow tools

Telelingua understands 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 have developed a secure on-line project management portal (based on Microsoft SharePoint technology), called T- Portal®, which centralizes information and gives our customers a tailor-made online tool to monitor the progress and status of any translation project (past, current and future).

Its key features are:

  • Available 24 hours a day, seven days a week, every day of the year; real-time access
  • Secure communication; customizable user rights
  • Automated documentation routing and feedback collection
  • Upload/download of files or detailed requests;
  • View/download/accept/reject quotations;
  • On-line display and consultation of glossaries
  • On-line customer validation of our translations
  • Standard Operating Procedures (SOP) adapted to customers’ requirements
  • Tailor-made traceability and reporting on a daily, weekly or monthly basis (QS, costs/budgets, schedules, status for each country/clinical study/document/language, in-country reviews, invoicing, etc.)
  • ISO-compliant archiving (files, questions/feedback from/to translators and revisers, etc.)
  • Flexible communication (reduced number of emails)
  • Customized regulatory and quality processes (naming convention, footer, versioning, Quality surveys, Quality Escalation Flow Chart and more)
  • Set up of “Quick Reference Guides” and “Best Practices”, and creation of training material & guidelines
  • Permanent Monitoring and Evaluation (M&E) process (meetings, conference calls, etc.).

Formats/Platforms

  • Macintosh and PC platforms
  • Microsoft Office
  • InDesign®, QuarkXPress®, FrameMaker®, PageMaker®, Illustrator®,
  • Photoshop®, Interleaf®, CorelDraw®, Ventura®, etc.
  • Visual Basic, C++, Java, ASP, HTML, XML, RoboHelp, etc.
  • Secure IT infrastructure