Clinical trials are the backbone of the life sciences industry. Their role in advancing our knowledge and bringing new treatments to market is undisputed. Increasingly, these trials are being conducted across multiple sites in different countries. This not only creates additional requirements regarding language translation and intercultural communication but also greatly increases the challenges and complexities of ensuring data privacy and regulatory compliance.
Life Sciences Localization: Translation + Adaptation
With the increasing number of international trials, participants from various jurisdictions, different nationalities, and diverse linguistic, cultural, and ethnic backgrounds are being recruited. In addition to translation as required for regulatory compliance, this situation also requires localization. If you are not immersed in the language services industry, you might understandably find this term confusing, especially regarding clinical trial data.
Localization (or l10n) is understood to mean translation with added adaptation for cultural and other factors. For instance, when localizing recruitment materials or a study calendar for use in a different country, you might need to reference different examples or forms of transportation for a given country. Graphics and images can also be an important part of localization: Cultures can vary greatly in the types of clothing deemed acceptable.
Data localization is a very different concept: it refers to the notion that data must be stored and processed within the borders of a specific country or region. 75% of countries have such regulations in place.
While study materials, ranging from informed consent and assent forms to investigator brochures and recruitment materials, are routinely sent for translation, it is primarily when it comes to highly sensitive personal information that maintaining data privacy in clinical trials becomes particularly relevant. This can include qualitative and quantitative data from electronic health records, e-diaries, trackers, questionnaires, etc.
Data Privacy in Clinical Trials: An Evolving Challenge
In clinical trials, protecting personal health information against breaches, unauthorized access, and misuse is crucial for regulatory compliance and maintaining participant trust. In international or cross-border trials, data may need to be shared across jurisdictions with differing privacy laws and regulatory requirements. In the age of AI, countries are strengthening their data privacy regulations, including the EU’s GDPR, HIPAA in the United States, Brazil’s LGPD, and China’s Personal Information Protection Law (PIPL). These generally stipulate transparency, data minimization, and explicit consent for data processing; however, requirements vary significantly across jurisdictions. In many cases, countries are also increasing enforcement and imposing steep penalties for non-compliance.
In this era of AI and machine learning, new regulations are expected to broaden the definition of personal data. For instance, the EU is planning to adopt new Standard Contractual Clauses (SCCs) to streamline compliance with international data transfers. An additional focus will be on enhancing individual rights, especially with regard to AI-driven decisions and algorithmic transparency.
Informed Consent: The Legal and Ethical Cornerstone
For a clinical trial to proceed, participants must complete the informed consent process. Language barriers can complicate matters: If a participant signs an ICF without fully understanding the implications, this could have severe repercussions for sponsors and investigators, ranging from data invalidation to disciplinary action or even malpractice suits. Errors or ambiguities in a translation can also invalidate consent, with similarly far-reaching consequences.
In addition to information about tests, timelines, and procedures, as well as the potential benefits and risks of trial participation, participants must also be informed of their rights regarding data collection and sharing, including any cross-border data transfers.
Data Collection and Regulatory Compliance
As we have seen, a veritable patchwork of overlapping and often contradictory local, national, and international regulations can apply when collecting, storing, and transferring data in the context of a global trial. Things become even more challenging when data must also be translated or localized for analysis, e.g., qualitative data from patient diaries, questionnaire responses, and patient-reported outcomes (PROs). The information may need to be routed through multiple systems and accessed by organizations and providers in various geographies governed by entirely different privacy laws. Maintaining privacy and compliance in this setting becomes a significant challenge, while the risk of breaches and unauthorized access increases.
Real-World Data (RWD)
Real-world data (RWD), such as data from electronic health records (EHRs), insurance claims, and patient-generated data (wearables, etc.), is increasingly used to complement clinical trial data. While RWD gives researchers a more comprehensive view of treatment effectiveness, safety, and usage in a broader population under more varied conditions than is possible in limited-time studies, it is also highly sensitive. When personally identifiable information (PII) and protected health information (PHI) must be moved across international borders and accessed, translated, and processed by stakeholders in different jurisdictions subject to varying privacy regulations, preserving data integrity and ensuring security are challenges that de-identification and privacy-preserving technologies can only partially address.
Prepare, Plan, and Prevent
Clearly, the stakes are high: when data privacy violations, such as the DM Clinical Research case, occur, the consequences can be costly, and the reputational risk is incalculable.
Fortunately, proper preparation and planning can go a long way toward preventing such a scenario. In addition to implementing strong security measures, it pays to work with qualified, certified providers for all contracted services. In a multilingual setting, especially when lacking in-house capacity, this means choosing a well-reputed, established, and ISO-certified language service provider with a roster of vetted, qualified, and trusted linguists working in a secure environment.
ISO Certification
In the life sciences localization industry, ISO certification – obtained through a rigorous process and renewed every 3 years – assures that a provider adheres to stringent quality management and data security standards. It also helps ensure that processes are both aligned with regulatory requirements and auditable. Two of the key standards in life sciences localization are ISO 17100 and ISO 27001:
ISO 17100 establishes requirements for language service providers (LSPs) regarding the processes, resources, and qualifications necessary to deliver high-quality translation services. LSPs must utilize well-qualified translators and implement quality control processes while maintaining confidentiality and adhering to security protocols.
ISO 27001 establishes a framework for implementing, operating, and monitoring information security management systems (ISMS), and also encompasses the management of risks associated with the organization’s data handling.
ISO Certification at Vistatec
Vistatec is proudly certified to ISO 27001:2022 (Information Security), ISO 17100:2015 (Translation Service Providers), ISO 13485:2016 (Medical Devices), ISO 18587:2017 (Machine translation post-editing), and ISO 9001:2015 (Quality Management System) standards. Via ISO 9004:2009, which provides guidance to organizations to support the achievement of sustained success through a quality management approach, we are strongly focused on building for the sustained success of the organization.
Risks and Opportunities of Machine Translation and GenAI
With the rise of machine translation and generative AI in localization and translation, it is essential to be aware that while these technologies can be a boon, they also pose unique risks, such as unintentional exposure or mishandling of personal data. Output can lack the cultural or contextual sensitivity necessary for effective cross-cultural communication and can be a source of errors and misunderstanding. Lack of consistency, for example, when different terms are used to describe the same pre-existing conditions or responses, may lead to distorted data and flawed conclusions.
Therefore, when using such technologies, expert providers must handle the process with the necessary human expertise and structured workflows to maintain compliance, accuracy, and trust.
Key Takeaways
Despite all the apparent complexities, maintaining regulatory compliance and data privacy in cross-border clinical trials comes down to the basics. Careful planning, a comprehensive, proactive approach, and partnering with trusted, experienced language services providers are the keys to success. LSPs like Vistatec are adept at addressing the complex challenges of the present moment and specialize in secure localization practices that keep your data and processes safe across the life sciences translation workflow.
Would you like to discuss this with our life sciences experts? Contact us today.