A statement issued by the European Medicines Agency (EMA) reinforced the notion that the method by which clinical trials were carried out would undergo strategic changes. These changes are attributed to the new Clinical Trial regulation that was passed earlier on in the year. The goal of the new regulation is to ensure that all clinical trials and research are fully transparent and consist of the highest safety measures for the patients involved. This regulation includes standard rules governing clinical trials all through the continent. The emergence of new regulations for clinical trials makes that all conditions posted must be strictly adhered to. For precise adherence to the conditions, language translation must be taken even more seriously. This is most essential given that the European Union consists of numerous countries with varying official languages.
This post covers the importance of accurate language translations for clinical research and trials.
- Transparency for the trial participant: Clinical trials have protocols that are to be followed. These protocols consist of the objective, method, treatment plan, organisation, and design of the trial. Most of these sections of the clinical trail protocols are filled with medical, statistical, and technical jargon that can otherwise be misconstrued by the trial patient. Given that these clinical trial protocols are presented in form of written documents and accompanied by select waivers, transparency/clarity is needed for the patient(s). This is even more essential if the trial patient is not acquainted with the localised language of the clinical research. For an effective trail, the trial patient needs to fully comprehend all aspects involved in the procedures to which they will be subjected.
- Global usage of research database: Once a Clinical Trial has been approved by the required governing bodies, such as the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) for the United States, and succeeds testing, research information on the trial can be requested by other agencies that desire to utilise the same practice. In terms of surgical practices and patented procedures, organisations that desire to follow the methodology initially utilised would require translations in their local language. This ensures that no measure is passed or misplaced due to lack of understanding. Clinical research and trials that are made accessible to other bodies should be translated into various languages.
- Required regulations by governing bodies: clinical trial regulations consist of strict guidelines that are to be followed down to the letter. In this age of globalisation, very few clinical trials are undertaken in the palace of their origin. Often, clinical trial protocols are developed in one location and implemented in another. For effective implementation and accurate Patient Reported Outcomes (PRO), translation of the protocols is required. When all involved parties have proper understanding of the protocols involved in a trial, it results in a strong risk decline that could affect patient health and organisation credibility. New clinical research regulations are being developed all with the aim to ensure that the practices used are ethical and do not constitute harm to the patient. Consequences that are plausible for failing to adhere to Clinical trial protocols include loss of license, severe damage or resultant death of a patient, and economic decline for the organisation.
It is obvious that most pharmaceutical companies invest significant resources into clinical research and trial, so it is only natural that translation services which they use should be the best. TranslationsinLondon have been providing quality translations of all forms all through our years in business. We pay due diligence to your work. Our approach consists of meticulous planning before implementation. From the moment our services are required, a rigorous selection process begins.
- We employ linguists that are native speakers of their target language with proven experience in the life-sciences industry.
- A project manager oversees the translation process with the aid of a team.
- An in-depth translation, proofing, and editing are carried out.
- Finished translations undergo a quality check.
- The final translation is to be approved by the project manager before dispersal.
At TranslationsinLondon, protection of the integrity of a business is paramount to us. Thus, we deliver nothing short of the highest standard.