Linguistic validation is a process of translating, reviewing and validating the accuracy, reliability, and conceptual equivalency for patient reported clinical outcome assessments (COAs). CSOFT Health Sciences manages the entire life cycle of an extended process of...
The world of clinical trials, global patient recruitment is a persistent challenge. Studies show that nearly 55% of clinical trials fail to meet their original recruitment targets, and about 30% of participants drop out before completing the trial. The diversity of...
Altamira Therapeutics Ltd., a company committed to developing therapeutics that address unmet medical needs, announced that Bentrio™ has been approved by the Philippines’ Food and Drug Administration (FDA) and is now cleared for commercialization. The product...
With regulatory documentation presenting an enormous range of requisite communications and regulatory filings, why is linguistic validation for patient questionnaires such an important area of focus for international clinical trials? As an increasing number of...
As more clinical trials shift toward decentralized models, utilizing methods that enable remote monitoring and self-reported patient data are allowing for a patient-centric drug development process that does not require in-person clinical visits. Nevertheless, many...
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