Approved vendor for clinical trials
PRECISE CLINICAL TRANSLATIONS
KONTEKST provides translations in the field of clinical trials to Contract Research Organizations, sponsors, and regulatory authorities across many countries and markets. We support our global CRO clients with comprehensive services at all stages of the translation process to deliver consistent and measurable results.
We are experts in clinical research translations in a vast number of languages, including English, Polish, German, French, Spanish, Italian, Russian, Ukrainian, Lithuanian, Latvian, Estonian, Hungarian, Bulgarian, Romanian, Swedish, Finnish, Czech, Slovak, Serbian, Dutch, Flemish, Portuguese, Chinese, simplified Chinese, Japanese, Persian, Arabic and others, including local language variants.
With our worldwide network of professional vendors and international partners we are able to handle any language according to your needs.
PROCEDURES AND PROCESSES
Clients want to work with approved partners who can offer certified solutions and ensure compliance with international industry standards. This is why we have quality assurance procedures in place at every stage of the translation process, including project management and monitoring, choice of translators, revision, and evaluation. Our procedures and processes are certified to comply with the PN-EN 15038:2006 standard – the first quality standard for the translation business. Our credentials are continuously being confirmed by audits from both official certification bodies and our most demanding clients.
Our customer satisfaction surveys confirm: our clients value us for the high quality of our work, both in terms of project management and linguistic quality of our translations. We boast a large in-house quality control team of 14 translators and revisers. A group of reliable experienced medical translators and partners enables us to provide translations across a range of different languages, in a fast and timely manner. Our translators are experts with a medical background and experience in translating clinical trial-related texts.
We use advanced IT tools and software to streamline our translation process and provide measurable and verifiable results in terms of consistency and unified terminology, which we know can be a challenge in long-term research programs. We manage client-specific glossaries and translation memories to ensure consistency across a number of translation projects. Our extensive databases enable us to provide customized services to all our CRO partners.
We offer a wide range of services extending far beyond just translation. With our experienced team and flexible workflows we are prepared to address our clients’ individual needs to provide tailor-made solutions to your full satisfaction. Our services include:
- Multilingual project management
- Terminology management
- Full IT support, including computer-assisted translation and TM management
- Unparalleled 20-minute response time with urgent priority projects
- A dedicated team of experienced experts in field
- Harmonization of different language versions
- Medical interpretation
- Certificates of translation accuracy
- Flexible and customized project management
We translate a wide variety of documents to support every stage of the clinical research and drug registration process, including pre- and post-marketing documentation. Our most common translation projects include:
- Informed consent forms (ICFs) and informed assent forms
- Clinical trial agreements
- Clinical trial protocols and protocol synopses
- Patient information sheets
- Patient diaries
- Patient questionnaires
- Emergency cards and patient cards
- Regulatory documentation and approval
- Correspondence with ethics committees and regulatory authorities
- Ethics committee opinions
- Clinical study results, case studies, and scientific publications
- Summaries of product characteristics
- Package leaflets
- Medicinal product labels
Our information security procedures have been reviewed during multiple audits performed by contract research organizations. We follow a strict confidentiality policy and hold an insurance policy to secure our clients' interests as well as our own in case of any translation-related issues. We provide our CRO clients with Certificates of Translation Accuracy according to their individual requirements and preferences.
Our client base includes 89 contract research organizations and pharmaceutical companies to date; we continue to attract new clients every day. We have won the confidence of many companies operating in the pharmaceutical market in Europe and around the globe.
Our precisely designed processes, verifiable metrics, and extensive use of advanced IT tools and technologies allow us to handle even the most complex and voluminous translation projects. In the years 2012 to 2015, we translated more than 52,000,000 words for a number of Clinical Research Organizations, regulatory bodies, sponsors, and pharmaceutical companies. Our daily output is an average of 150,000 words of quality translation.
Every year, we provide roughly 15 million words of translations for life sciences businesses. To date, we have supported a total of over a thousand worldwide clinical trials. Our translations reach clients in 22 countries. Within the last 2 years we have worked with 200 language combinations.
Contact us to learn more about our CROptimized methodology at KONTEKST!