What does thebigword offer the Life Sciences industry?

Extensive experience in life sciences has enabled thebigword to develop a comprehensive understanding of this evolving sector. As developments continue within the industry, with the introduction of new medical devices, ever changing compliance requirements, introduction of new drugs, and implementation of clinical trials, life sciences organizations require a language services partner with the expertise and breadth of experience to successfully produce high quality, expert level translations while adding value to their bottom line. thebigword’s understanding of stringent industry regulations and both national and international requirements represents a fundamental differentiator that distinguishes us from some of the top language service providers in the industry. This knowledge and understanding is at the foundation of the specialized workflows established by thebigword for a number of the largest life sciences organizations in the world.

Furthermore, our advanced technology, thebigword GMS® (thebigword Globalization Management System®), is a key reason why some of the largest life sciences organizations choose thebigword to communicate complex clinical trial and product information across multiple languages in each region. Every day we deliver translation and localization to a global audience for an extensive range of clients, in fields including:

• Pharmaceuticals
• Biotechnology
• Medical Devices
• Drug Approval/Manufacturing
• Contract Research
• Healthcare

Who makes up our dedicated Life Sciences team?

A translation error in the life sciences industry can be hugely detrimental, so accuracy is one of our key priorities. thebigword’s staff is dedicated to finding the most experienced translators in each appropriate field, with the language skills to convey the message in the clearest manner possible. The life sciences industry requires detail-oriented explanations, technically accurate content, and extensive knowledge of medical terms and vocabulary.

Only specialist linguists with a proven background in the life sciences sector are chosen to work with our healthcare clients. Their expertise ensures accuracy while respecting deadlines and budget constraints. Specialist Project Managers maintain links with the industry’s regulatory bodies to ensure we are always informed of changes or new developments. This keeps us up to date with the very latest procedures and regulations from the FDA, EMA, MHRA, and MHLW. thebigword has built a specialized operational team that works solely with our life sciences clients – this team consists of Quality Managers, Project Directors, Project Managers, Global Resource Managers and Linguistic Team Leads –  who devise and manage tailored workflows to meet the specialized requirements of this type of content.

thebigword’s dedicated life sciences division includes:

• Committed life sciences resources strategically located throughout our nine global offices
• Specialists experienced by subject area – medical, pharmaceutical and biosciences
• A network of linguists, covering a range of therapeutic areas
• Translation from and into over 234 languages
• Key focus on quality, accuracy and client confidentiality: our certifications include ISO 9001:2008, EN 15038:2006, and ISO 27001:2005

Our extensive pool of medical experts, unique technology and specialized operational support ensure we provide our clients with an unrivalled range of cost effective, high quality services. At thebigword, we know that life sciences clients will only choose an LSP they can rely on and trust. Our current long-standing life sciences clients continue to work with us because we deliver the results they need to reach a range of diverse audiences.

Specialized translation

At thebigword we know the life sciences industry is looking for the following distinguishing factors: a cooperative manner, technical proficiency, adaptability, stability, and a commitment to quality. Accuracy in healthcare documentation is paramount to ensure the health and safety of individuals across the globe. We have a range of industry accredited professional medical linguists who translate an extensive variety of documents taking great care to ensure that each one not only meets regulatory requirements but is also suitable for the target audience. This expert medical team uses wide-ranging specialist knowledge to translate and localize content, before applying our unique technology and effective processes to guarantee every translated document is completely appropriate for its intended use.

Core services available:

• Forward translation
• Back translation
• Review and Proofreading
• Quality Assurance
• Reconciliation
• Harmonization
• Linguistic validation – including cognitive debriefing
• Cultural adaptation and consulting

  

Within these areas, our project-specific experience covers a wide range of subjects; examples of some specialist projects include:

• Medicine/Medical devices:
  • Manuals Installation, Maintenance, User
  • Product/System Specifications
  • Operating Guides
  • Packaging and Labeling
  • Regulatory Documentation
  • Patents
  • Contracts
  • Websites, Intranets, and Extranets
  • Product Catalogs
  • eLearning Modules
• Clinical:
  • PRO/ePRO instruments and scales
  • Informed Consent Forms (ICFs)
  • Subject diaries
  • Pharmacovigilance material, including SAE reports
  • Translation of content for IVR (Interactive Voice Response) and IWR (Interactive Web Response) systems
  • Case Report Forms
  • Clinical Protocols and related amendments (phase 1, 2 and 3)
  • Quality of Life questionnaires
  • Patents
  • Labeling
  • User guides
  • Manuals
  • Medical forms & records

• Regulatory:
  • Regulatory/Marketing Authorization submissions
  • IFUs / DFUs
  • Patient safety documentation
  • Product labels, inserts and packaging
  • Service and operator manuals
  • Dossiers
  • Submissions to Ethics Committees
  • Clinical Agreements
  • QRD/Product Information documentation

Localization and Website Translation

The internet provides a great business opportunity for the life sciences sector to reach more customers and maximize profits. Our experienced project team understands the importance of ensuring accuracy and meeting stringent regulatory requirements. Time is also a key factor and we have implemented workflows supported by our innovative technology to ensure that critical information is delivered exactly when you need it.

Producing dynamic websites on time and within your budgets is all part of the service. To achieve these objectives, a project plan and workflow is developed for each project, covering all stages of the process. It identifies how we will work with your internal resources and reviewers for a seamless result from start to finish.

Our experts have experience working with all types of files; we can easily integrate your Content Management System with our own translation management system, thebigword GMS®. Developed in-house, thebigword GMS® has an innovative feature which ensures the structures and coding within your files are protected throughout the translation process, saving you valuable resource time.

 

Multimedia and Voice-over

Because we are one of the few LSP’s to be a full service provider, we have both the industry experience and in-house capabilities to fully support our clients’ multimedia requirements in addition to document, website or software localization. Our team has experience in video and animation, audio material and using Flash as well as XML. We can even complete your artwork to produce localized online presentations and incorporate it all into eLearning for cost effective ways to keep your international staff up to speed.

Project Management and Engineering teams at thebigword create a tailored workflow for each multimedia project and assign each stage clear ownership and sign off. Our engineers complete a full analysis of your products, while our Project Managers advise on the best practices for each translation step in the project. Regular updates mean you can track your project’s progress making this complex process simple and transparent.

We cover areas such as:

• Scripting
• Voiceovers
• Translations
• Subtitling
• Dubbing
• Graphic localization
• Editing
• Reviewing
• Post production

thebigword is one of the only global LSP’s within the industry to have an in-house voice-over recording and production studio. This is one of our key differentiators and one reason why some of the largest global organizations choose thebigword to support their international multimedia requirements. These organizations appreciate not having to find a separate supplier to provide these services. Our clients can continue to work with their dedicated Project Manager while also reaping the benefits of lowered costs and faster turnaround times for multimedia production.

Our clients can rest assured that their multimedia content is being translated by life science experts, overseen by their dedicated operational team who serve as partners within the localization process; all while having the ability to choose voice-over talent and maintain visibility of the production workflow and ongoing progress.

  

What will the future bring for Life Sciences clients?

The volume and complexity of life sciences translation work requires a team of dedicated professionals who can keep up with a field that is constantly evolving. Our latest state of the art technology coupled with our ability to recruit the most highly qualified linguists ensures that all projects will be completed efficiently and in a timely manner.

As an established and trusted pioneer of language services for over 30 years, we have demonstrated continued success through technical innovation, strategic global support and ongoing development and training of our staff. Our focus is to apply automation and technology to the translation workflow in order to assist companies in their centralization efforts, while offering a full language service solution. The strategic steps that we have taken to continually improve quality through technology and automation, while also driving down costs and turnaround time, have made thebigword one of the most financially sound and fastest growing language service providers in the world.

We continue to place our focus in the following areas in order to deliver the best language solutions in the industry:

• R&D and Technology Development – including the recent release of thebigword GMS® technology.

• Training and Development investment. This investment includes eLearning and classroom training in our UK and US training centers.

• Opening additional strategic regional locations around the world to align with our clients’ requirements and goals.

• On-the-fly automation of the workflow to decrease turnaround times and costs within the translation process.

We have built a truly global team dedicated to providing translations that are technically proficient and accurate, whilst also meeting stringent requirements specific to the life sciences sector. Our commitment to, and understanding of, these specific needs is what makes us the primary choice among pharmaceutical, biotechnology and healthcare organizations.

thebigword’s ongoing investment in our technology, providing automation that lowers costs and increases quality, is a testament to our commitment to improving service levels for our life sciences clients. By listening to our clients’ requirements, focusing on the future, and utilizing industry specific experts who create real solutions for specialized project requirements, thebigword continues to demonstrate itself as the true leader for language services within the life sciences sector.