ACENTH is a full-service Contract Research Organization (CRO) dedicated to supporting clinical trials for In Vitro Diagnostic (IVD) devices. We specialize in conducting FDA-compliant studies for 510(k), CLIA-waived, and laboratory-based diagnostic products, including point-of-care and home-use tests.
Our team brings deep expertise in study design, regulatory strategy, site management, and subject enrollment across diverse therapeutic areas. With a strong focus on quality and efficiency, ACENTH partners with diagnostic developers to streamline clinical validation and accelerate time to market.
Whether launching a novel molecular test or validating a rapid antigen device, ACENTH provides the scientific rigor and operational excellence needed to support successful regulatory submissions.
Key Services:
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Clinical trial management for IVD and medical devices
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Protocol design and regulatory consulting
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CLIA-waived and home-use study execution
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Site network with high-volume enrollment capacity
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FDA submission and documentation support