The clinical trial setting is experiencing a period of unprecedented change, with a flood of new technologies, regulatory flux, Brexit, the Clinical Trial Regulation that comes into effect in 2019, and the constant flow of new innovations. As many of the processes involved in clinical trials are now outsourced, drug trial sponsors and CROs, such as those attending the 8th Annual Outsourcing in Clinical Trials trade fair in Barcelona, need to address the challenges that outsourcing brings.
Language needs in a global setting
So far in 2018, more than 270,000 trials have been registered in 203 different countries, according to Trends, Charts, and Maps – ClinicalTrials.gov.
Clinical research has become such a global arena that clinical trial protocols can be designed in one country and implemented in another, with a completely different language and culture. Overcoming the language barriers inherent in this reality, in a field with a high failure rate (only 1 in 10 study drugs make it from study to commercial sale), presents many challenges.
Translation is needed at almost all stages of a clinical trial, in different styles and registers. Simple-to-understand formats for patients, such as informed consent forms and patient information leaflets, have strict requirements but need simple, direct language so that patients with no medical training can understand everything about the trial and what will happen to them. More complex clinical trial protocols, case report forms, and investigator brochures for the researchers, sponsors and regulators use more technical language and jargon. Legalese is needed for legal agreements. Insurance terminology for policy agreements.
Having a reliable language services partner goes a long way towards smoothing out these issues for outsourcers and participants.
Translation services outsourcing
Translation is often treated as an afterthought in the clinical trial industry – a rushed necessity at the end of a long, costly process. Yet high-quality translation is an integral part of the process of running a clinical trial, and crucial for its success. Outsourcers need to have guaranteed high-quality, experienced, and reliable services on hand.
Outsourcers need to seek out language service providers with experience and certification, who focus on, and guarantee, high quality and accuracy to overcome the linguistic hurdles that national boundaries present, smoothing the process of transferring data from one location to another.
Accuracy is non-negotiable because data integrity cannot be compromised. There is no place for misunderstandings, confusion, or imprecise interpretations in this field. The health and wellbeing of the trial participants, the credibility of the research, and the revenue and ultimate outcome of the trial are all at stake.
Translation and localisation services should provide staff who have extensive experience in the field of clinical trials, plus native language skills and cultural knowledge of local areas. They will then be able to provide culturally sensitive localisation of documents for local markets that have different needs in terms of information required and cultural expectations.
CPSL has extensive knowledge of the issues involved in translating and localising clinical trial documents from our many decades of experience. Plus, our triple ISO certification guarantees our quality processes to our clients, which now number 120 industry-leading names, including Bayer, Bio-Rad Laboratories, EKF Diagnostics, Novartis, Oxford Instruments, Trinity BioTech and many more.
In the midst of massive technological change and regulatory flux, being able to rely on an expert language service will come as a welcome relief to pharma and biotech companies seeking to expand into foreign markets – whether now or in the future – so join a long list of industry-leading names including Bayer, Bio-Rad Laboratories, EKF Diagnostics, Novartis, Oxford Instruments, Trinity BioTech and many more, for your translation and localisation needs.