RWE, RWD, & Retrospective Imaging Analytics in Clinical Trials
Transform clinical images into powerful real-world data (RWD) for retrospective real-world evidence (RWE) studies. IAG enables sponsors to unlock strategic value from historical and multicenter imaging archives – empowering retrospective analysis to accelerate research, validate regulatory claims, and deliver robust insights for precision medicine and market access.
Many organizations face limitations with traditional RWD, but retrospective imaging analysis overcomes these barriers by revealing actionable evidence hidden in existing clinical trial images and routine-care datasets. Our experienced team and the DYNAMIKA™ cloud-native platform harmonize, quality-check, and centralize imaging data from global sites, making retrospective studies seamless, audit-ready, and regulatory-compliant.
Compliance
Our platform and services adhere to the highest compliance standards, ensuring full regulatory alignment.
FDA 21 CFR Part II
ISO13485
GDPR
HIPPA
SOC 2
Innovation in Retrospective Trial Imaging
Dynamika™ and IAG enable biopharma sponsors to optimize real-world evidence generation whether by analyzing historical clinical trial data, registries, or post-market surveillance images.
Leverage AI-enhanced analytics, advanced imaging biomarkers, and protocol-driven quantification methods to conduct retrospective cohort studies, external control arm creation, safety monitoring, and long-term outcome research.
Our cloud-based platform streamlines massive image repository curation, automated QC, and batch processing, supporting retrospective multicenter studies for regulatory submissions, health economics, and outcomes research (HEOR). Integrated AI tools enable rapid identification of novel imaging endpoints, subpopulation stratification, and detection of efficacy or adverse signals in diverse, real-world patient cohorts.
What you can Expect with IAG
Robust Data Capture & Management in RWE or Phase 4 Studies
Use DYNAMIKA’s cloud-native platform for centralized, secure imaging data collection with automated QC tailored for real-world settings.
AI Tool as a Treatment Efficacy Companion
IAG Team builds novel AI tools which support treatment efficacy assessments through automated image analysis. We place these AI Tools on DYNAMIKA, which instantenously enables your clinical sites to benefit from your innovative ideas and developments.
Validation of Your AI Tools
Partner with IAG to conduct validation of your imaging data analysis tools through ground truth radiological reviews, ensuring regulatory compliance.
Radiomics and Multiomics
DYNAMIKA empower seamless collection, curation, and unified analysis of these multimodal datasets—supporting AI-driven patient stratification, and novel endpoint development. Integrating radiomics and multi-omics accelerates drug development, enables smarter trials, and paves the way for personalized therapeutic strategies that leverage the synergy of medical imaging and advanced molecular diagnostics.
Beyond Imaging, Large Scale AI
Our team develops and applies scalable machine learning and AI models that go far beyond traditional image interpretation, powering sophisticated solutions for biomarker discovery, patient stratification, trial optimization, and predictive analytics. IAG’s expertise encompasses advanced data harmonization, federated learning for secure cross-institutional AI development, and large vision and language models to extract insights across narratives, reports, and images.
This holistic approach accelerates drug discovery, allows for deeper phenotyping, and generates actionable evidence from massive, diverse patient populations. Our large-scale AI models support everything from target identification to companion diagnostic development and real-world outcomes analysis. With IAG, sponsors gain access to a partner who expertly bridges imaging with big data science—delivering solutions that uncover patterns, reduce risk, and drive smarter, faster decisions throughout the drug development pipeline.
End-to-End Imaging AI Support
By embedding AI models in DYNAMIKA’s cloud infrastructure, sponsors benefit from real-time analytics and streamlined operations throughout the trial lifecycle
Discuss Your Upcoming Clinical Trial
Unlock the Power of Imaging in RWE and AI-Driven Studies.
Project Initiation and Data Acquisition Planning
Align objectives by defining study goals, datasets, and timelines. Identify imaging or other data sources, establish standardized formats, and plan centralized data collection using the DYNAMIKA platform.
Pilot: Retrospective Validation and Benchmarking
Validate image analytics models on curated historical cohorts, ensuring integrity and reliability for submission or regulatory review.
Platform Integration and Workflow Customization
Seamlessly integrate image search, batch uploads, automated QC, and real-time reporting for retrospective and secondary data use protocols.
Multi-Site Deployment and Ongoing Retrospective Support
Execute large-scale retrospective imaging studies across multi-regional data sets with continuous quality assurance and analytics updates.
Case Studies
IAG and Takeda Collaborate: AI-Powered Histopathological Image Analysis
Image Analysis Group (IAG) and Takeda Pharmaceutical Company Limited formed a publicly announced partnership to transform histopathological image analysis in ulcerative colitis (UC) using artificial intelligence (AI). The collaboration’s goal was to develop, validate, and deploy an AI-driven tool to assist gastroenterologists in accurately assessing UC disease activity and therapeutic efficacy, especially in settings with limited access to expert pathologists. Leveraging IAG’s DYNAMIKA platform, the project began with rigorous multi-center development and validation of deep learning models on a curated set of 200 histology images—achieving diagnostic performance comparable to human experts. The AI tool was then field-tested at eight world-leading clinical sites spanning Switzerland, France, Canada, the USA, Israel, Portugal, Brazil, and other regions, reflecting a truly international effort. The partnership resulted in the publication of a full manuscript in April 2024 in the United European Gastroenterology Journal and included major presentations at global conferences like Digestive Disease Week 2024. Co-authored by IAG’s founder, Dr. Olga Kubassova, the project demonstrated how AI can automate, standardize, and enhance UC image evaluation, ultimately supporting precision medicine and delivering better outcomes by rapidly putting assessment tools into the hands of practicing gastroenterologists worldwide. This collaboration highlights IAG’s expertise in operationalizing AI in clinical research and its commitment to advancing diagnostics and patient care in GI diseases.
IAG and Ferring Collaboration: Innovation in Women’s Reproductive Health
Image Analysis Group (IAG) and Ferring Pharmaceuticals have forged a strategic partnership to revolutionize women’s reproductive health through advanced imaging and AI-driven analysis. Ferring, a global leader in reproductive medicine, collaborates with IAG to leverage the DYNAMIKA platform for large-scale, AI-powered analysis of complex pregnancy and fertility imaging data. This alliance directly supports Ferring’s mission to enhance the chances of healthy pregnancies for women worldwide by embracing innovation in research and technology. The collaboration focuses on deploying IAG’s scientific and technical expertise to address critical gaps in women’s health, using DYNAMIKA to efficiently manage and analyze vast multi-center datasets with embedded AI modules. Through this partnership, innovative imaging biomarkers and quantitative endpoints are being explored to advance treatments and improve clinical understanding in areas such as fertility, maternal health, and pregnancy outcomes. The integrated approach enables precision, scalability, and scientific rigor across Ferring’s global studies. Senior leaders from both organizations highlight their shared commitment to AI-driven, patient-centric research. Dr. Philippe Pinton of Ferring emphasized the partnership’s role in tackling challenges in complex fields like pregnancy, while Dr. Olga Kubassova, CEO of IAG, reaffirmed the vision to transform women’s health worldwide through data-driven innovation and collaborative scientific discovery. This collaboration stands as a model for utilizing AI and advanced imaging to drive impactful change in reproductive medicine and maternal health.
Merck and IAG Collaboration: Quantitative Muscle MRI and Myositis
Merck, in partnership with leading academic and industry experts—including IAG’s Dr. Olga Kubassova, Dr. John A. Carrino, and Dr. Lisa Christopher-Stine—undertook a landmark project to transform the assessment of idiopathic inflammatory myopathies (IIMs) such as polymyositis, dermatomyositis, and inclusion body myositis. Published in Frontiers in Immunology in 2025, this collaborative research reviewed and advanced the role of quantitative muscle MRI in diagnosing and monitoring myositis. Traditional MRI provides valuable qualitative insights for IIM diagnosis but has limitations for quantitatively tracking disease activity and progression. This project evaluated cutting-edge quantitative MRI techniques—enabling objective measurement of muscle edema, fatty replacement, and atrophy. The vision was to establish robust, reproducible imaging biomarkers that could sensitively reflect disease activity, supporting clinical trials, drug development, and real-world patient management. The international, multi-institutional effort brought together clinical, academic, and industry expertise to set a new benchmark for imaging in myositis. The resulting publication, co-authored by Kubassova, Carrino, and Christopher-Stine, highlights the transformative potential of advanced quantitative MRI to guide precision treatment, improve disease monitoring, and enhance endpoint reliability in rare autoimmune muscle disorders. This work spotlights IAG’s role as a key partner in deploying innovative imaging methodologies for high-impact, sponsor-driven research in rare diseases.
Eli Lilly, Robarts, and IAG Collaboration: Accelerating IBD Drug Development
Eli Lilly, Robarts Clinical Trials, and Image Analysis Group (IAG) joined forces to advance the development of breakthrough therapies for inflammatory bowel disease (IBD) by harnessing cutting-edge quantitative imaging and artificial intelligence methodologies. Recognizing the limitations of conventional, subjective image scoring, the collaboration aimed to validate innovative imaging biomarkers and harness AI for more sensitive, objective assessment of Crohn’s disease activity. In this partnership, MRI data from Crohn’s disease patients was centrally collected and analyzed using IAG’s proprietary methodologies, deployed through the DYNAMIKA platform. IAG contributed deep scientific and operational imaging expertise, enabling the identification of specific and sensitive imaging biomarkers tailored to inflammatory disease mechanisms. Robarts, a leader in IBD clinical research, brought global clinical trial execution and patient-focused insights, while Lilly provided pharmaceutical development leadership and a commitment to innovation. The project delivered actionable, data-driven strategies for efficient drug development, providing greater precision in measuring inflammation and tracking treatment response than traditional methods. The success of this collaborative approach was highlighted by all partners: “The use of the right imaging and quantitative methodologies has the potential to accelerate early drug development by providing greater precision than conventional assessments,” noted Dr. Olga Kubassova, CEO of IAG. Ultimately, this collaboration is a model for using AI-enabled, quantitative imaging analytics to speed clinical R&D, lower costs, and enable smarter, patient-centered therapies for IBD.
Amgen’s MOSAIC Study—Leading Data Management, Expert Coordination, and Proprietary Inflammation Analysis
In the pivotal Phase 4 MOSAIC study, Amgen sought to advance the understanding and treatment of psoriatic arthritis through the world’s first use of MRI to assess inflammation in both peripheral joints and entheses. Image Analysis Group (IAG) was selected as the imaging CRO, working alongside Amgen and numerous leading academic centers across Europe and North America. IAG’s team was responsible for centralized data management, ensuring that all imaging—from over 120 patients and multiple study sites—was collected, stored, and processed with audit-ready integrity using the advanced DYNAMIKA platform. As a hub for scientific coordination, IAG facilitated collaboration with global key opinion leaders, harmonizing multiple MRI review methodologies (including PsAMRIS and whole-body scoring) to guarantee consistency, robustness, and scientific rigor across the trial. Beyond standard image management, IAG applied its proprietary techniques for quantitative inflammation analysis, enabling deeper insights into how Apremilast reduced bone marrow edema, synovitis, and tenosynovitis. By integrating its own advanced analysis and supporting all clinical investigators with centralized expertise, IAG helped transform complex multi-site data into clear, regulator-ready evidence. This expert contribution was instrumental in establishing objective MRI-based endpoints, informing regulatory and clinical understanding, and ensuring the success of the MOSAIC trial as a benchmark for innovation in rheumatology research.
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