Early Phase Trial Imaging
The Image Analysis Group (IAG) provides cutting-edge medical and quantitative imaging expertise to help Sponsors design and implement the most effective imaging strategies for early-phase trials. This enables deeper exploration of drug efficacy and safety while contributing to the development of a robust target product profile and identification of the right patient population.
Through the DYNAMIKA platform, IAG streamlines the collection of imaging data from global trial sites, applying real-time quality control (QC) at the point of upload. In early phase I–II studies, this empowers Sponsors to extract maximum exploratory value from imaging datasets.
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
Early Phase Trials
Imaging is a powerful driver of early-phase clinical success—offering non-invasive, objective insights into drug efficacy, tissue-specific responses, and disease progression. Unlike biomarkers alone, smart imaging delivers clear evidence of mechanism-of-action and accelerates confident go/no-go decisions.
IAG ensures imaging works harder for Sponsors. Our experts design optimized imaging strategies, enforce rigorous global data quality control, and apply advanced quantitative methods—such as biomarker extraction, radiomics, and multiparametric analytics. This allows us to uncover subtle signals of efficacy and build robust, data-driven product profiles.
With IAG, Sponsors gain precise, actionable insights into a drug’s biological impact—even in small or heterogeneous cohorts—empowering faster, evidence-based development decisions and stronger pipelines.
What You Get with IAG?
Dedicated Project Management and Operational Guidance
In early phase imaging trials, having dedicated project management and operational guidance is essential for success. IAG assigns experienced project managers who work as an extension of your team from the outset, coordinating every aspect of trial setup, imaging logistics, and site activation. Our experts proactively identify and address potential bottlenecks, oversee site training, and ensure all imaging data is collected, reviewed, and processed according to rigorous quality standards. With clear communication pathways and real-time problem solving, sponsors benefit from smooth study execution, rapid issue resolution, and full transparency. This unwavering operational oversight allows you to focus on your trial’s scientific outcomes, confident that every imaging process is expertly managed for quality, compliance, and efficiency.
Real-Time, High-Quality Imaging Data Collection
Sponsors get seamless global imaging data collection with immediate, automated quality control, ensuring data integrity and minimizing lost or unusable scans.
Rapid Support for Patient Safety
DYNAMIKA and our central radiology review function enables near-instant review of safety imaging, supporting timely safety assessments and fast responses to potential adverse events—critical in first-in-human trials.
Advanced and Novel Analytics
In early phase trials, IAG goes beyond regulatory endpoints by implementing novel quantitative imaging techniques and advanced imaging biomarkers. This approach enables early identification of drug efficacy signals and provides objective, data-driven go/no-go decision support—even in small or heterogeneous patient cohorts. We are recognized for our smart use of AI and state-of-the-art imaging analytics to explore patient responses and strengthen sponsors’ scientific hypotheses.
Flexible Exploratory Analysis
The platform supports in-depth subgroup analysis, biomarker discovery, and retrospective hypothesis testing, arming sponsors with valuable insight into pharmacodynamics, patient stratification, and mechanism of action.
Integrated artificial intelligence tools can automate image analysis, identify complex phenotypes, and extract patterns not visible to the naked eye, delivering extra value beyond standard reads.
Regulatory-Ready Data and Audit Trails
In early phase imaging trials, IAG delivers fully compliant data management with complete, traceable audit trails. Every imaging record is securely captured, anonymized, and documented to meet international regulatory requirements—ensuring your dataset is always inspection-ready and easily supports future filings or reviews.
Discuss how we can support Your Trial
Effective delivery of the early phase trial will enable you to comprehensively assess drug efficacy and safety, select targeted patient population and increase chances of success of your later phase trial. IAG team helps to address these pain points with expertise and fit-for-purpose platform that is flexible, scalable, and cloud-based, with end-to-end workflows for image collection, management, automated quality assurance, and centralized read support. DYNAMIKA will support advanced modalities and endpoints, offer real-time logistics and compliance oversight, and integrate seamlessly with other trial systems—tailored to biotech teams with limited resources but ambitious scientific goals.
Discovery & Study Design Alignment:
Following the initial conversation, IAG’s experts work with the sponsor to understand protocol requirements and imaging objectives. Together, they define imaging endpoints, data needs, and regulatory considerations to guide the project’s scope and technical specifications.
Site Onboarding & Training:
IAG coordinates the selection and qualification of optimal imaging sites and provides comprehensive training. This includes DYNAMIKA platform access, detailed upload/QC instructions, and site-specific operating procedures to guarantee imaging consistency.
Platform Configuration & Testing:
DYNAMIKA is tailored to the study’s needs, setting up automated workflows for image upload, anonymization, real-time QC, and secure data storage. Test uploads are conducted with sites to validate each workflow and ensure readiness.
Go-Live & Real-Time Data Collection:
The study launches, with sites now submitting patient imaging to DYNAMIKA. Automated QC flags issues instantly, supporting rapid intervention, compliant data capture, and near-immediate safety assessments when needed.
Ongoing Support, Insights, & Expansion:
IAG maintains ongoing technical and scientific support, providing regular data status updates. As the trial progresses or evolves, advanced analytics, subgroup exploration, and AI-driven analysis can be deployed, ensuring the sponsor’s needs are met from initial setup through trial closeout and beyond.
Case Studies
Case Study: Accelerating Oncology Drug Decisions with AI-Driven Imaging
A biotech company leveraged IAG’s DYNAMIKA platform for a phase I/II brain tumor trial. By automating data collection and real-time QC, image acceptance rates improved by 40%—cutting rescan requests and saving over two weeks in patient enrollment cycles. With IAG’s advanced AI analytics, the sponsor identified early efficacy signals in just 30% of expected cohort size, reducing time to interim decision by three months. This allowed rapid expansion decisions and a confident regulatory submission, directly shortening the overall trial timeline and reducing costs.
Case Study: Streamlining Patient Safety in Immunology Trials
In a multi-site immunology trial, IAG’s immediate imaging QC on DYNAMIKA enabled detection and reporting of adverse imaging findings within 24 hours for 100% of cases. Previously, such reviews could take up to a week. This fast turnaround improved patient safety monitoring and enabled the sponsor to adapt protocols in real time. Overall, the use of centralized, audited imaging workflows resulted in a 25% decrease in protocol deviations and a 20% increase in patient retention due to safer, more responsive trial management.
Case Study: Enriching Trial Populations and Reducing R&D Spend in Rare Disease
A sponsor developing a rare musculoskeletal therapy used IAG’s platform to stratify patients via quantitative MRI biomarkers and AI-based sub-grouping. This approach enriched trial cohorts with likely responders, increasing observed treatment effects by 35% and halving the sample size needed for statistical significance. The trial’s operational costs dropped by 30% compared to traditional designs, and the company secured additional funding two quarters earlier than projected, thanks to robust, regulator-ready efficacy data.
Case Study: Seamless Scale-Up: Advancing a Bone Health Therapy from Early to Late Phase Using DYNAMIKA
A biotech company developing a novel bone health therapy seamlessly advanced from early to late phase trials by partnering with IAG and leveraging the DYNAMIKA platform. In phase I, IAG supported the sponsor by configuring DYNAMIKA to collect and centrally store DXA and X-ray images from a global network of sites, providing real-time QC and rapid site support. This ensured baseline patient selection was accurate and imaging endpoints were standardized. As the trial moved into phase III, the same platform enabled the sponsor to expand to over 50 sites across Europe and enroll more than 1,200 patients while maintaining data quality and compliance. DYNAMIKA reduced the time from image upload to QC report to just 0.4 days, and from QC report to final report to 2.2 days—accelerating both interim analyses and regulatory submissions. With automated workflows and integrated analytics, patient eligibility and efficacy results were available faster, streamlining trial operations and decision-making. Critically, by using DYNAMIKA throughout all phases, the sponsor achieved up to a 35% reduction in trial budget and completed recruitment ahead of schedule. IAG’s platform delivered full scalability, unparalleled data traceability, and regulatory readiness from first-in-human studies through to registrational submissions, markedly increasing the likelihood of both regulatory success and investor confidence
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Talk to Imaging Specialist
If you are planning a clinical trial which involves imaging to assess safety or efficacy of your drug, speak to our team and propose an optimal solution for your imaging data management and review.