QUALITY MANAGEMENT

IAG brings many 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 platform DYNAMIKA is developed under ISO13485 and compliant through the use of Quality Management System (QMS) with Standard Operating Procedures.  IAG is audited by clients on regular basis. 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 work of multiple stakeholders.   With the integrations platform like DYNAMIKA these risks are essentially eliminated with the ongoing surveillance, cross checking, and cleaning of the data.

DYNAMIKA, IAG’s cloud platform brings together

 

  • comprehensive suite of data management workflows for sites, readers and Sponsors,
  • trial management tools,
  • image review methodologies, 
  • integrated A.I. tools for further data analysis

Our 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.

Through rigorous quality function, we ensure that all regulatory requirements of a trial delivery as well as validation of the novel approaches has been taken care of, so that you can brign them into your trials.

IAG, Image Analysis Group

We help drug developers to effectively use imaging, such as MRI, CT, and PET to accelerate drug development and lower investment risks. Whether you are entering a phase I/II and need early robust efficacy data or preparing a successful H2H or superiority trial, our science, operations, and technology teams will work with you to develop the right solution.

Planning a trial and would like to learn more about IAG and DYNAMIKA?

Email: imaging.experts@ia-grp.com

DYNAMIKA

DYNAMIKA is IAG’s proprietary enterprise-scale cloud-based platform for imaging processing and data management. It works across multi-centre trial settings to enable central imaging review.​

This one comprehensive software system controls trial progress conducts central reads and, when needed, it can be integrated with AI tools for earlier read-outs and decision support.