In the journey of drug to reach in to the market, document translation is required at many stages, including manufacturing, packaging, clinical research, regulatory submissions and marketing. Among this clinical research plays unique and major role as multi-country trials. Most drugs that are manufactured and developed in India are intended to sell in abroad. This results in continuous-increasing demand for translations of clinical research documents, especially translation of ICF to facilitate volunteers who participate in clinical trials.
We accept the fact that every single document generated and used at every stage in clinical research / trials is of grave importance. Hence Quality of the translation can have enormous impact on commercial ethical and legal aspect. However at different geographical places it is not possible to generate clinical research in local/ vernacular language. In majority cases source documents are prepared in English language. As per ICH GCP E6 section 4.8.6 The language used in the oral and written information about the trial, including the written informed consent form, should be as nontechnical as practical and should be understandable to the subject or the subject's legally acceptable representative and the impartial witness, where applicable.
Our translation services are intended to remove language and cultural barriers between volunteers to participate in clinical research and trials. Our objective is that the non-English speaking volunteers get the same high quality information to that of English-speaking volunteers as per regulatory requirement. We provide prime quality ICF translation services, clinical research document translation services, medical document translation services.
Each Translator of GCP Monitor has more than 6 years of experience in the healthcare field. The unique experience of translator ensures quality of all translated documents. Our prime objective at GCP Monitor is to meet the standards of applicable regulatory body. Any word in one language, may not be equivalent in another language, or could have a completely different or opposite "meaning" or effect in the translated language.
This is why translation is considered as an art rather than a science. Hence qualified translators are required who can express the intended meaning in the target language rather than translating document word for word.
GCP Monitor utilizes linguists who are experts in clinical trials and clinical data management. At GCP Monitor, we have expert team of translators with impeccable linguistic skills and technical writing expertise.
Sometimes cheap translation may results in very expensive end product. For example – a poor quality translation if ICF can lead to Misguidance of clinical research volunteers, Rejections by regulators, Increase in total cost of trials, Delay in approval and marketing of drug products, Affect the safety and efficacy data of the marketed product
All these drawbacks can be avoided only by getting the documents translated by a translator who has qualification, experience of translating the documents with medical background.
GCP Monitor provides document translation service to world wide clients. Our major clients are from Ahmedabad, Vadodara located in Gujarat, Mumbai in Maharastra, Banglore, Pune, Chennai etc. Translators of GCP Monitor are expert in translation of clinical research documents, medical documents, pharmaceutical documents. Our Unique Selling Proposition "USP" is to provide timely and professional services at reasonable prices.
We translate clinical research documents, ICF, pharmaceutical documents, medical documents from English into Gujarati, Hindi, Marathi, Tamil, German, Russian, Ukrainian and many more languages. We also translate documents from Gujarati, Hindi, Marathi, Tamil, German, Russian, Ukrainian to English.
