29 Jun Translational medicine and Medical translation for CROs
Translational medicine, or evidence-based research, is a bidirectional concept. It aims to improve human health by determining the relevance of novel discoveries to disease, both coordinating knowledge and clinical practice and using direct human observation to characterize disease and generate new hypotheses. Medical translation is essential in any event, as it plays a key role in clinical evidence-based research.
Introduced in the 1990s the term was not spread until the early 2000s. Nevertheless, since the beginning, this practice has enhanced interdisciplinary collaborations, the use of advanced technologies, and therapeutics, applying what has been revealed in preclinical evidence-based research safely to clinics. Anyway, international clinical tests in traslational medicine need to conform to the Declaration of Helsinki (World Medical Association), and therefore, the test language must be understood by both doctors and patients.
New types of CROs are arising, affecting medical science from concept to market
CROs and Medical Translators pivotal roles in the chain from discovery to market
CROs have emerged as functional aspects specialists. They continuously diversify following expanding market demands and new types of CROs are arising, affecting medical science from concept to market. This evolution encourages expansion and multi-site clinical trials, which usually require multiple languages documents.
From utility companies for Sponsors, CROs can nowadays suit sophisticated demands of medical, pharmaceutical and device industries, such as tissue engineering repairs, biocompatibility of implants, or pharmacodynamics. There is, however, a well-known division among CROs: Preclinical CROs which deal, among others, with matters related to drug screening, device manufacturing, toxicology or compound synthesis. And Clinical CROs that mainly deal with regulatory requirements and the human aspect of the trials.
In this sense, CROs require reliable results that add value to the product development process. Every project must be carefully documented and efficiently managed. And, on top of that, Sponsors must receive on-time translations. CROs are essential to dissemination of scientific evidence-based research and to promote the development of society and traslational medicine. That dissemination implies, different localizations and different languages, that must be mastered to facilitate the results of any study, as communication is an essential part of them.
New CROs functions include assisting disease diagnosis, introducing personalized care or visualizing disease progression, being essential to deliver translational medicine, as the number of new drugs or medical devices under development continues to grow. Medical translation for CROs, on the other hand, must be built on the understanding that what is needed is reliable results that add value to the product development process.
The fusion between biologics and devices, and other market changes. Medical Translation is still basic
Evolution has, in the first place, reduced delineation between biologics and devices. Therefore, demands for clinical practices, regulatory reviews or health care operations have also evolved, although regulatory requirements for clinical trial remain, despite translational medicine, or evidence-based research. This explains why quality control procedures that ensure complete translation process by medical and linguist experts is mandatory.
Pharmaceutical companies are interested in integrated services from a single CRO. However, bearing in mind that this request has the same pitfalls of the old system, a successful alternative, that joins the specialization of CROs and the one-window shop to facilitate achieving goals on-time, is Expertise-Based Integrated Service (EBIS) concept which is compatible with translational medicine, or evidence-based research focus.
Although the pharmaceutical industries initially hold intellectual properties, joint ventures and mergers and acquisitions have blurred the initial structure between companies and brands, aiming to convince regulatory bodies and even corporate partners. Nowadays, CROs can also hold IP.
The often needed back translation, cognitive debriefing or harmonization of the patient responses, still persists too in translational medicine. No wonder, as data must be accurate and consistent in all the languages that are needed for the trials. Without it, data analysis cannot be correctly performed, which implies that faulty or inaccurate translations can render trials inadequate. Can you imagine the drug company loses?
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