DYNAMIKA V.7 has achieved the British Standards Institute (BSI) surveillance audit certification following a recent SOC II Type I compliance certification
Image Analysis Group (IAG), a leading imaging Clinical Research Organization (iCRO), announced the release of their award-winning DYNAMIKA V.7, the latest version of the cloud-based platform for managing and analyzing imaging data in clinical trials. Following a recent SOC II Type I compliance certification, V.7 has achieved the British Standards Institute (BSI) surveillance audit certification.
DYNAMIKA was recently named an Award Category Winner for Innovation in the 2024 Pharmaceutical Technology Excellence Awards, recognizing the platform’s proprietary technology and its potential for driving change in the pharmaceutical industry.
“This milestone is another important step as IAG continues to bring innovation to the medical imaging space,” said Dr. Olga Kubassova, founder and President of IAG. “Having such comprehensive quality compliance allows IAG to partner with companies seeking effective imaging biomarkers to support safety and efficacy of their drug candidates in clinical trials, as well as those who envision using these imaging endpoints in clinical settings as companion diagnostic tools.”
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Through intelligent medical imaging workflows for data management, quality control, and central review of clinical imaging, DYNAMIKA streamlines medical imaging in trials to help investigators assess treatment efficacy and safety. DYNAMIKA:
- simplifies and automates imaging workflows with a user-friendly interface.
- accelerates the radiological reading process, reducing site burden and increasing site participation and collaboration.
- promotes greater consistency in radiological reads, enhancing the accuracy and reliability of imaging assessments.
- facilitates data interoperability, consolidating information to provide operational leaders with comprehensive, real-time insights to make informed decisions.
- supports Phase I-IV trials of all sizes.
DYNAMIKA was developed in compliance with both 21CFR Part 11, which establishes the United States Federal Drug Administration (FDA)’s regulations on electronic records and signatures, and ISO 13485, the internationally recognized standard for quality management systems in the design and manufacture of medical devices. This underscores IAG‘s commitment to maintaining the highest standards of quality, compliance, and security in its operations while pushing the boundaries of innovation in clinical research.
Source: PRNewswire