Clinical trials need to go faster. With an overall success rate of only about 14%, and each trial carrying the weight of potentially hundreds of thousands of dollars each day, pharmaceutical companies’ performance hinges on conducting trials with greater efficiency.
Do you know how your translation vendor impacts your timeline, your budget, and your success?
Language support plays an integral role in studies domestic and abroad. Today, roughly 46% of all worldwide studies take place outside of majority English-speaking countries. Inside the U.S., 1 in 5 Americans speak a language other than English at home. Being able to target the right patients, means being able to speak their language.
Whether just beginning to search, or evaluating a current vendor, it’s essential to consider whether they are helping or hindering the efficiency and efficacy of your trials.
Document Management
By Phase Three of a clinical trial, there can be thousands of participants involved, and at least two years of previous testing. With any project of that scope and scale, there are countless materials to track. This is especially true of global projects involving multiple languages. Sorting through the paperwork to make sense of a project’s timeline is more time-consuming than many project managers can afford.
A single, unified platform can greatly assist in organizing, tracking version control, monitoring progress, and providing peace of mind. Passing versions back and forth via email takes time, effort, and becomes convoluted -- it can be easy to violate data regulation requirements and the whole team doesn’t retain visibility. Having one, designated online space allows everyone the ability to view a consistent record in real-time, no matter their geographic location.
Editing
As stated in Clinical Methods, “Cross cultural interpretation … requires special training and highly developed skills. Just any bilingual person, chosen at random, is not sufficient.”
Increasingly, service providers are integrating translation memory into their services to increase efficiency and cut costs for clients. Programmed to recall precise translations, they undeniably save any project time. However, even the most meticulously translated sentence can end up producing a wildly different meaning, possibly at a company’s expense. To remedy this, transcreation is used to recreate an intended meaning or reaction, and it is often required in discussing medical subjects across different cultures.
Choosing the correct terminology for clinical trial translations is a highly developed skill. A single mistranslation can result in costly budget increases and downstream liabilities seeking necessary approvals from in-country reviewers and institutional review boards are one of the primary drivers behind increased timelines and costs of clinical trials. Language Service Providers should facilitate communication between linguists and reviewers to increase speed and decrease the risk of misinterpretation through non-language professionals.
Compliance Regulations
The right translation vendor will partner with you to ensure compliance requirements are met.
The FDA Amendment Act mandates that all clinical trial participants be provided with enough information to make an informed decision about their participation, including dosage instructions, potential side effects, data protection, and insurance requirements. It’s essential for this data to be fully understood by both parties in order for an ethical, legal clinical trial to take place.
Miscommunication within this process could seriously endanger a patient, emphasizing the importance of partnering with a language provider you can trust.
For trials involving foreign participants specifically, one of the largest hurdles is in navigating the array of cultural differences which impact understanding.
Patients may not comply with conditions for any number of reasons arising from their unique worldview, life experiences, and beliefs. Outside of patient compliance issues arising because of language barriers, further complications can come from strongly held cultural beliefs that aren’t properly addressed, or even considered, in discussion. For example, one study references “hot-cold” treatment beliefs prevalent in Asian and Latino cultures which may cause an individual to cease certain treatments.
A key question to consider in searching for a language provider is whether they can aid in dealing with location-specific knowledge. If documents are translated in a way which considers this knowledge, going further to recreate the originally intended meaning, understanding between the two parties can be greatly expedited.
Your Next Translation Provider
With on-demand services, 24/7 support, and a user-friendly and secure centralized translation platform, GLOBO helps clinical trials get to market faster. For every project, no matter its size, we provide you with a dedicated project manager capable of connecting you with in-country experts in over 250 languages.
Clinical trials are costly. Ensuring seamless communication shouldn’t make it any more so. Learn more about how to save up to 50% on your next project:
