A comprehensive linguistic validation service helps you to meet the requirements for successfully clearing the Clinical outcome assessment (COA) by strongly following the FDA and ISPOR procedures. This service also helps you to meet the regulatory agency standards by ensuring reliability, patient data accuracy and content validity of translations. At Ulatus, we ensure that the translated terminologies and concepts are culturally equivalent and adapted according to the regulator’s strict guidelines.
Clinical trials are increasingly being internationalized. Also, the development of instruments is being predominantly in English. Ulatus’ incorporated ISPOR compliant Linguistic Validation and Cognitive Debriefing methodology ensures that your translated COA (Clinical Outcome Assessment) instruments are both conceptually equivalent with the original source and relevant to the new target culture.
Ulatus demonstrates in-depth expertise by ensuring that your instrument conceptually, culturally, and constructively coequal all targeted languages.
Inadequate attention given to inputs received from patients, clinicians, regulatory agencies, payers or sponsors, creates needless hurdles.
This could lead to the concept(s) of interest being :
Ulatus’ linguistic validation team helps to interpret all the content rightfully in order to retain its real meaning and assure consistency. The professional clinicians and healthcare professionals coupled with FDA and ISPOR compliant practices allow us to conduct cognitive interviews. Our explicit objective is to minimize error in measurement of the concept of interest (COI) and achieve clarity in the interpretation of study results when evaluating treatment benefits.
When it comes to localization solutions, Ulatus provides the most efficient structures and equipment to guarantee maximum quality in any project!
I have been using Ulatus services regularly for some time now and their quality of work is really good. The style and accuracy with which they translated my various documents was exactly what I expected it to be. I am really impressed with their team who worked closely with me to translate our vision into reality.Desiree Lui, Abbott Informatics Asia Pacific Ltd.
When we approached Ulatus, we initially asked for literal translation. But when the authors reviewed the translation style, they wanted the text to be more fluent. So right in the middle of the project, Ulatus changed the style from literal to paraphrasing. We are so thankful to Ulatus for accommodating this change.Dr. Makoto Inoue, University Of Tokyo Press
Looking at the quality of the work that was produced, I could not have done any better. I know Japanese and I know linguistics, and looking at the quality of the work that was produced, I feel like I would not have done any better than this.
We ensure your documents are translated accurately
Academic experience backed by strong professional experience, this translator has vast experience in the field of biochemistry and molecular biology. He has more than 8 years of translation experience. He is an American English native and is fluent in English, Japanese and other languages like Mandarin Chinese, Spanish, and German. He is proficient in Japanese to English translation and checking.
This translator has had a long and illustrious career. She has more than 10 years of experience as a consultant to various hospitals and healthcare facilities across Asia in addition to more than 5 years of experience in echocardiographic examination. She is a Japanese native and currently resides in South Africa.
This translator is a Pharm.D. in Pharmacy and Biochemistry from University of Sao Paulo and has more than 10 years of translation experience. He is a member of the Society for Clinical Data Management and is currently a Clinical Data Quality Manager at Bristol-Myers Squibb, Brazil. He has advanced knowledge of clinical operations, data management, budget and contracts, SAE/eSAE processing, management and monitoring of clinical trials, onsite monitoring, vendor management, Phase IIV clinical development, post-marketing trials, regulatory compliance, clinical pharmacology, medical writing, drug supply, and IVRS processes.
He is a translator specializing in Homeopathy, Naturopathy, Nutritional-based Therapies, Health Information Manage-ment, Healthcare,Economics, Hospital Management, Public Health Management, Allergology, History of Medicine, Pulmonology Medicine, Family Nursing, Geriatric Nursing, and more. Heobtained his pharmacy degree from the Kaohsiung Medical University in Taiwan. He also has a Master’s degree from the Texas State University. His work expertise reaches close to 30 years in translating.
With a master’s degree in Preventive Veterinary Medicine, this licenced Veterinarian has worked for over 10 years in the translation industry. She holds 16 years of total expereince in various industries across Taiwan and US. She is a skilled professional in subjects like Neurology, Oncology, Ophthalmology, Orthopedics, Veterinary Medicine, Anatomical/Surgical Pathology, Clinical Pathology/Anatomical Pathology, Orthopedic Surgery, Pharmaceutical Toxicology, etc.
This editor has over 38 years of experience in writing and editing scientific documents, including original peer-reviewed research papers, book chapters and technical articles. He has authored and reviewed papers published in high impact journals such as Proceedings of the National Academy of Science (USA), the Journal of Virology, Virology, the Journal of the National Cancer Institute, Cancer Research, and Oncogene. He has received two awards: “Federal Technology Transfer Award” from the National Cancer Institute, USA and “Director’s Award” from the National Institutes of Health, USA.