ISO13485 and 21 CFR part 11 Quality Management


IAG brings over 10 years of experience in advising on and delivering imaging critical clinical trials, where advanced imaging based biomarkers provide critical evidence of the novel compound safety and efficacy.

Our services are ISO13485 and 21 CFR part 11 complaint through the use of Quality Management System  (QMS) with Standard Operating Procedures.  (audited by clients and regulatory agencies). The QMS is audited on annual basis by British Standards Institute (BSI) and bi-annually by internal auditors, prompting continuous improvement of our processes and procedures.

According to the FDA, the main reason trials fail to meet their endpoints has nothing to do with the science of the drugs, but with trial execution problems – failure to follow protocol, incomplete data, inconsistent data, and failure to track the study drug.   With the integrations platform like DYNAMIKA these risks are essentially eliminated with the ongoing surveillance, cross checking and cleaning of the data.

IAG is the world’s only clinical research organization with FDA510K accredited imaging biomarkers developed in house and acquired via strategic partnerships.

DYNAMIKA, IAG’s platform brings together comprehensive suite of data management routines, trial management tools and image review methodologies, including those driven by AI. In-house R&D team is continuously working with the world’s leading academics on transferring their innovative ideas onto DYNAMIKA platform to ensure that our clients can benefit from the latest scientific innovation while ensuring that all regulatory requirements of a trial delivery as well as validation of the novel approaches has been taken care of.

IAG, Image Analysis Group

Our next-gen platform, R&D and service divisions together with funding mechanisms holistically address the broader issues experienced by biopharma with active and often complex clinical trial pipelines by providing an integrated approach to clinical development and strategic planning.

DYNAMIKA, Image Management Platform

Real-time information, patented data analysis methodologies, flexible reporting options for all stakeholders that ensure transparency of trial delivery and the use of the latest scientific innovation in proving efficacy of your novel treatments.

Contact Us