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Wiitrans is committed to providing comprehensive and high-quality language services to the life sciences industry. We are one of the few language service providers with the international ISO 9001, ISO 13485, ISO 17100, and ISO 27001 certifications, and our life sciences team is highly experienced. Our team provides efficient, accurate, and compliant language services to medical device manufacturers, contract research organizations (CROs), contract development and manufacturing organizations (CDMOs), pharmaceutical companies, and biotechnology companies all over the world. We support more than 40 languages to help you with your global regulatory submissions and business activities.
Quality management systems
Quality management systems
for medical devices
International requirements
for translation services
Information security management
systems
Linguists with experience and academic background guarantee consistency in terminology and accuracy of translations. Wiitrans has dedicated translation teams that provide services to the various disciplines of life sciences industry. Each team comprises high-caliber translators and reviewers specializing in fields within the industry, including pharmacy, pharmacology, clinical medicine, biology, medicinal chemistry, analytical chemistry, and immunology, etc. We also have a pool of subject matter experts (SMEs) who provide technical/academic support to our project team.
At Wiitrans, each life sciences account is managed by a dedicated team. Besides utilizing general industrial experience, our teams are also customized. We accept training from client side, to know more about the products, and interact frequently with client review team for constant optimization of translation results.
Wiitrans is a technology-driven language service provider, and over the years, we have constantly made use of advanced technology to optimize project workflow and management. Among these solutions is our online cloud-based translation tool, WiiCAT. WiiCAT is a system that provides a central platform for translators assigned to a project to work together and communicate in real time, reducing the time needed for project management. WiiTM, our language asset management system, comes with an automated terminology management feature that makes it easier and faster for translators to refer to terms. It also reduces the possibility of human error and the time needed for subsequent terminology cleanup.
By using dedicated translation teams with substantial industrial experience alongside advanced technology, our life sciences solutions are designed to overcome language challenges and to help global enterprises achieve their ultimate goal.
One of the challenges in the biotechnology and pharmaceutical industries is the submission of accurately translated documents within limited time. Timelines for drug registration are generally stringent, and delays in the preparation and compilation of source documents and submission of translated documents can result in late marketing of a drug.
At Wiitrans, biotechnology and pharmaceutical translations are assigned to professional teams comprising translators with relevant background, and reviewers who would rigorously and thoroughly review translated documents from the perspective of the end user. To ensure consistency in style and content, translations for the same production line or product are performed by the same group of translators.
With our specialized teams in biotechnology and pharmaceutical translation, you can trust us with the translation of your documents for submission to agencies, including but not limited to:
FDA
EMA
NMPA
PMDA
Clinical studies conducted in multiple languages are key to the international development of medical products. When planning global clinical trials, language services must be fully considered in a timely manner to ensure that the study is initiated and completed as planned. From our vast experience providing language services to various CROs, we truly understand that every clinical trial project is unique in terms of phase, document type, format specifications, and timeline.
At Wiitrans, clinical trial documents are assigned to experienced translators, proofreaders, reviewers, and SMEs. To protect the confidentiality of clinical trial and research documents, persons involved in the translation are required to adhere to all relevant safety procedures, including the signing of a strict confidentiality agreement before the start of the project and working in an internal secure room.
For more than 20 years, Wiitrans has been providing localization services to many of the world's leading medical device manufacturers. At Wiitrans, medical device documents are translated by linguists with at least 5 years of experience in medical device translation, and our multilingual desktop publishing (DTP) team ensures that documents and materials are compliant and published in the right format and layout.
At Wiitrans, we constantly keep ourselves updated about developments, information, and the latest regulatory requirements in the industry to ensure compliant and customized language services for our clients. Therefore, our health care team strictly adheres to internal quality control standards and makes sure every translator sufficiently understands regulatory laws and terminology. This is to ensure accurate use of standard medical terms while strictly adhering to requirements such as the Medical Dictionary for Regulatory Activities (MedDRA) and standards of the European Directorate for the Quality of Medicines (EDQM).
The client is a multinational innovative pharmaceutical company that aims to provide high-quality and affordable novel biologics to patients around the world, including tumors and autoimmune diseases. The client has multiple R&D centers and laboratories in China and overseas, and with their R&D capabilities and foresight, they have laid out a diversified innovation pipeline for monoclonal antibodies and combination immunotherapies for tumors. Over the years, the client's pharmaceutical product lines have continued to expand.
The client’s new drug application for NMPA often involve high-volume contents such as study protocols, investigator's brochure, study reports, CRFs, ICFs, safety reports, and clinical literature. The translation projects grew as the product lines expanded, and the client's previous language service provider was no longer able to meet their high expectations for quality and turnaround time. The client needed a new and experienced language service provider for high-quality and efficient services to support their NDAs. In view of the intense competition in the pharmaceutical industry, the client was also extremely concerned about measures to protect confidentiality during the translation process.
Wiitrans is known in the industry for its strict selection of translators. Our multidimensional selection framework includes testing of all potential translators, periodic testing of existing translators, and quality tracking. This framework allows us to select native translators with both language competence and industrial knowledge. The backgrounds of our translators include, but are not limited to, pharmacy, pharmacology, clinical medicine, biology, pharmaceutical chemistry, and chemical analysis.
Projects are also fully supported by our experienced project managers, industry experts, and account managers. For this client, we established a dedicated and experienced VIP team, and through interactions with the client, we were able to readily meet the client's quality expectations. Based on product lifecycle, the project manager also formed a customized team that can be expanded and downsized for the client as needed to ensure no productivity issues.
Before the start of the translation phase, our team lays a strong foundation quality by communicating with the client, performing information collection, holding internal solution discussion meetings, and training by industry experts. Translation is performed by translators with appropriate language competence and industrial background. The translation is then reviewed for accuracy, consistency, and style by editors who would then complete a quality report. The QA personnel performs spot checks on the quality of translation throughout the process and retrospectively identifies quality issues. Results of the quality report are directly associated with the translator's key performance indicators (KPIs), and this fundamentally enhances the quality of translation at every part of the process.
An exclusive translation memory and terminology database are created for each of our clients to ensure consistency and accuracy. Language assets of the client are also securely stored and updated for exclusive use by the client only. In subsequent projects for the same client, discounts are given based on the number of repetition and high fuzzy matches from analysis using the exclusive translation memory. This ensures that repeated texts are translated consistently and significantly reduces the client's translation cost.
For high-volume, urgent projects, Wiitrans works according to the client's timeline and responds in a prompt manner. We also develop solutions through process optimization and proprietary project tools. For example, our system synchronously displays the translations of all translators involved to provide real-time update on the progress of translation. We allocate quality resources and operate 24/7 to ensure projects are delivered with quality by the specified due date.
The confidentiality and security of projects are protected through team configuration, translation process, hardware configuration, and management policies. All project documents transmitted are encrypted, and we take multiple measures including web servers, firewalls, and security maintenance for solid data security. In terms of hardware configuration, our office is equipped with fingerprint identification systems and surveillance cameras. Wiitrans is a paperless office, and special projects are handled in confidential rooms. In addition, all employees are required to sign a confidentiality agreement. Appointed staff perform checks on confidentiality and devise ways to improve the protection of confidentiality.
The final translation outcome met the client's expectations, and application documents were submitted on time. Meanwhile, the utilization of language assets improved efficiency in translation project and reduced the client's cost of translation by nearly 35%. In addition, our translation quality was recognized by the client's regulatory affairs department, and with their recommendation, we cooperate extensively with the client, including their clinical, overseas marketing, and medical departments. To date, we have translated more than 2.6 million words for the client. We will continue to do our best to provide excellent language translation services to our clients and contribute to global developments in life sciences.
