How can pharmaceutical companies and clinical research organizations benefit from medical translation during the clinical trial process?
As part of the FDA Regulations relating to Good Clinical Practice and Clinical Trials, US companies must translate documentation into local languages when conducting research in foreing countries. Skipping the clinical trial translation step or having it poorly done could result in facing a lawsuit or rejection by regulating authorities.
It is advisable that professional medical translations are used for all the phases of the clinical trial process.
Asides from that, how else can pharmaceutical companies and clinical research organizations benefit from medical translation during the clinical trial process? Some of the biggest challenges faced when running clinical trials come down to recruiting, engaging and retaining patients.
Recruitment, engagement and retention of patients
A survey conducted by CISCRP showed that, even though there is common ground on the importance of clinical research to discovery and development of new drugs, less than 5% of Americans have ever participated in a clinical trial. Moreover, a study on average dropout rates stated that only 7 out of 100 identified patients complete the trial.
Innovations in clinical research were sped up during COVID pandemic and some, like the implementation of virtual trials, are becoming a new reality. Such patient-centric studies make it possible to recruit patients globally and increase trial diversity, minority and ethnic representation and difficult-to-approach patient groups enrollment. Decentralized trial models allow patients to participate from the comfort of their homes and skip site visits.
These innovations require the translation of information and documentation into different languages at an increasingly fast pace. Making a specialized Language Service Provider your partner during the clinical trial process will guarantee not only that you comply with the FDA regulations, but also that you reach a wider and more diverse range of patients and support their participation through comprehensible information.
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