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Why are decentralized clinical trials (DCTs) becoming the go-to model for improving patient-centric medicine? With an increasing number of pharma companies and sponsors conducting clinical trials overseas, DCTs are an evolving solution to the clinical trial landscape, combining aspects of telemedicine and mobile medical care to deliver remote and hybrid clinical trials. With new frontiers in patient-focused care and innovative medical technologies, DCTs help to improve patient recruitment and patient retention by using devices and technology to make it easier for patients to participate and capture patient data remotely. As the clinical trial landscape thus becomes more decentralized, clinical trial translations are increasingly essential to the process of engaging patients across borders, supporting patient diversity in multi-national clinical trials, and enabling drugs to compete in international markets.

Decentralized Clinical Trials: Key Features and Overview

More and more, trial sponsors and the pharma industry are reshaping our ability to accurately collect patient data remotely and address longstanding challenges to conducting clinical trials by using the DCT model. At the core of DCTs is the integration of different technologies and devices such as wearables, mobile apps, and telemedicine, which enable remote data collection and remote communication with trial participants. Ultimately, enhanced data collection methods and improved communications benefit some of the core elements of clinical trials, including:

  • Improved patient recruitment, engagement, and retention
  • Expanded patient diversity and geographic diversity
  • More accurate and timely data collection
  • Decreased patient burden

With the ability to participate in a clinical trial remotely, patient burdens like the time and money spent traveling to and from trial sites can be mitigated, and sponsors are able to avoid the costs associated with operating a site. Moreover, the remote aspect of DCTs allows for representation from multiple countries, which further drives patient diversity, as the trial is not linked to one specific location. By eliminating barriers to entry and making it easier for the patient to participate, sponsors can see a greater adherence to the protocol amidst heightened rates of patient retention and recruitment.

Cross Border Medical Communications: Decentralized Clinical Trial Translations

Though technologies and remote monitoring devices work across borders to track data and health metrics, the increased number of DCTs has also driven a heightened demand to localize clinical trial materials, including electronic informed consent forms (eICF), electronic clinical outcome assessments (eCOA), and telemedicine, which are foundational to DCTs. Increased patient diversity and the scalability of DCTs prompts sponsors to ensure documents are available across any number of languages, which is a further requirement when competing in markets like the EU. Moreover, DCTs enable sponsors’ inclusion of trial participants from racially and ethnically diverse populations in the US as well as globally, demanding the availability of multi-lingual patient documentation and other localized trial documentation (e.g. for CT sites, regulatory authorities, and IRBs) needed to meet stringent regulatory requirements for document translations. Specific localization solutions essential for successful DCTs include eCOA translations and linguistic validations, mobile medical app localization, and eICF translations.

For sponsors and pharma companies competing in the global clinical trial market and in need of medical localization services, CSOFT Health Sciences provides a full range of translations for clinical trials, in addition to mobile medical app localization and linguistic validation for eCOA/COA in more than 250 languages.

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