Voiant, a leader in clinical trial imaging solutions, is proud to announce the successful completion of an inspection conducted by the U.S. Food and Drug Administration (FDA).
WALTHAM, Mass., April 2, 2024 /PRNewswire-PRWeb/ -- Voiant, a leader in clinical trial imaging solutions, is proud to announce the successful completion of an inspection conducted by the U.S. Food and Drug Administration (FDA). The rigorous inspection encompassed an evaluation of the company's procedures, organizational structure, Voiant's imaging platform: Voiant Hub, and the entire trial data process—from the moment of images receipt from clinical sites to the secure transfer of data endpoints to sponsors, including data verification crucial for a New Drug Application (NDA).
The FDA's inspection team meticulously examined Voiant's practices and protocols, affirming the company's adherence to the required standards of documentation and data integrity from the outset of clinical trials.
Laura Guzman, VP of QA and Regulatory Compliance at Voiant, said, "We are delighted to receive such positive feedback from the FDA inspectors. Their recognition of our robust processes—having no concerns and encouraging us to 'keep up the good work'—validates our team's dedication to maintaining exceptional data integrity and comprehensive documentation practices."
This successful inspection not only underscores Voiant's unwavering commitment to quality but also enhances the company's standing as a reliable partner in the journey from clinical trials to market-ready pharmaceuticals.
"As we continue to pave the way for the future of clinical trials imaging, this validation from the FDA serves as a testament to Voiant's diligent and systematic approach to every aspect of our work," Jim Primerano, CEO at Voiant, added.
The results of the FDA inspection reflect Voiant's promise to uphold the highest standards in all areas of its operation, ensuring that all partners, stakeholders, and regulatory bodies can have the utmost confidence in the company's processes and outputs.
About Voiant
Voiant is a leader in clinical trial imaging solutions, swiftly delivering high quality endpoints to help Biopharmaceutical Companies achieve their clinical trial objectives and deliver new therapies to patients in need. Additional information is available at www.voiantclinical.com.
Media Contact
Stephane Deleger, Voiant, 1 (877) 374-3207, [email protected], https://www.voiantclinical.com/
SOURCE Voiant
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