Image Analysis Group
Imaging Clinical Research Organization to support your trials
Accelerate your clinical trials with the industry leading imaging platform DYNAMIKA, optimal Imaging Endpoints Strategy and power of AI.
Therapeutic Areas
Discover how IAG Team can deliver tailored, measurable results for your trial.
see: https://www.ia-grp.com/trial-solutions/
Rheumatic and Autoimmune
Appointment Management Agent
Provides automated scheduling, reconfirmation, and rescheduling with 24/7 human-like responses seamless calendar integration with real-time updates.
Corporate Training Agent
Provides personalized training, quizzes, one- on-one coaching, owner-curated topics, and performance tracking with individual improvement suggestions.
Business Personal Assistant
Participates in conference calls, maintains follow-ups, has uses memory from past interactions, engages in debates, sends meeting invites, and more.
HR Assistant
Streamlines recruiting tasks, manages onboarding/offboarding, handles policy Q&A, assists with performance reviews, and advises on employee benefits.
Oncology / Immuno-oncology
AI BDR (BizDev Rep)
Lead Qualification, Engagement, Capturing. Engages website visitors with contextual voice conversation, identifying intent, and passing leads to CRM or scheduling calls with human sales agents.
Personalized Products and Services Recommender
Helps users with personalized recommendations of products or services, assists with shopping cart management and checkout via voice conversation.
Sales/BDR BANT Lead Qualification
Qualifies leads through BANT-focused (Budget, Authority, Needs, and Timeline) voice or text conversations, collecting key lead information for human sale rep handoff.
Sales/BDR Trainer Agent
Provides personalized voice training and coaching, real-time feedback, assessments and suggestions for improvements to sales and BDR trainees on how to pitch company products and services.
Client Simulator
Trains sales teams through voice simulations of real client types and objections across various industries.
Neuro-Oncology
Customer Support Agent
Enables automated inquiry resolutions, interacts via voice or text chatting, prioritizes requests, and rounds them to relevant human support agents.
Appointment Management Agent
Provides automated scheduling, reconfirmation, and rescheduling with 24/7 human-like responses seamless calendar integration with real-time updates.
Customer Survey Agent
Conducts engaging voice-based surveys, offers user guidance with smooth conversation flow, and fills out web forms or surveys by voice assistance.
Bone Health / Osteoporosis
Sales Assistant
Consults website visitors about banking services, identifies intent, qualifies leads, passes them to CRM, or schedules calls with human sales agents.
Debt Collection Assistant
Sends follow-ups, payment reminders, proactive risk alerts, issuance final notices, and seamlessly escalates to human agents when necessary.
Customer Support Agent
Enables automated inquiry resolutions, interacts via voice or text chatting, prioritizes requests, and rounds them to relevant human support agents.
Client Onboarding/ Retention Specialist
Streamlines client onboarding by personalized consultations, automating account registration, verifying customer data, ensuring seamless enrollment.
Cardiometabolic / Obesity / Diabetis
Provider Claims Manager
Handles provider calls, shares claim status updates, explains denials, and accepts new claims via voice.
Table of Benefits Expert
Provides expert support on insurance coverage and benefits relevant to the customer based on the member’s insurance policy.
Fraud Prevention Agent
Ensures claims are validated by engaging with members post-service, reduces financial losses and operational inefficiencies by detecting fraud early.
Customer Data Intake Specialist (Tier 1)
Provides data intake, collects, and organizes customer history to feed into the product recommendation engine. Cuts questions for returning customers.
B2B/B2C Insurance Sales Assistant (Tier 2)
Provides personalized policy recommendations, automates follow-ups, guides customers through the enrollment process for higher quality conversions.
Product Onboarding/ Retention Specialist (Tier 3)
Streamlines client’s onboarding process by personalized consultations, automated registration, and ensuring an efficient enrollment experience.
Existing Member Success/ Care Agent
Сontacts patients after their healthcare visits to gather feedback, leverages data integration and scripted dialogues for personalized interactions.
Debt Collection Assistant
Sends follow-ups, payment reminders, proactive risk alerts, issuance final notices, and seamlessly escalates to human agents when necessary.
Rare Diseases
Health Coach / Health Advocate
Delivers personalized guidance, health check-ups, medication and care plan adherence tracking, coaching in nutrition, weight management, and more.
Diabetes Management Health Coach
Supports diabetes patients with positive interviewing, encouraging self-care, and healthy habits.
Appointment Management Agent
Provides automated scheduling, reconfirmation, and rescheduling with 24/7 human-like responses seamless calendar integration with real-time updates.
Patient Data Intake Specialist
Provides guided data intake, collects medical history, analyes data to prioritize patient needs, reduces redunant questions for returning patients.
Behavioral and Mental Health Support Agent
Automates mental health screenings, offers empathetic support, ensures mental health resources availability anytime without waiting for appointments.
Neurosciences
Voice AI Chatbot For Your Startup
Optimizes lead flow and user engagement through voice and text chatbot on your website and apps.
Nuclear Imaging and Dosimetry
Sales/BDR Trainer Agent
Provides personalized voice training and coaching, real-time feedback, assessments and suggestions for improvements to sales and BDR trainees on how to pitch company products and services.
Corporate Training Agent
Provides personalized training, quizzes, one- on-one coaching, owner-curated topics, and performance tracking with individual improvement suggestions.
Client Simulator
Trains sales teams through voice simulations of real client types and objections across various industries.
Personal Trainer
Personalized voice coach for learning – guides users with interactive lessons and feedback.
Why Work with IAG?
Worldclass Medical Imaging Expertise in Trials
Experience in Medical Imaging
Image Analysis Group’s project management is praised for its experienced, globally distributed team, collaborative culture, and proven success in complex clinical trials, leveraging advanced technology and operational excellence to ensure timely, high-quality project delivery in imaging research
Experience in AI and Advanced Imaging
The experience in AI and advanced imaging for drug trials highlights AI’s role in enhancing imaging quality, speeding lesion measurement, and improving disease detection and response monitoring, which streamlines workflows and reduces timelines. Advanced imaging techniques like PET, MRI, and bioluminescence enable real-time visualization of drug-target interactions, optimizing dose and efficacy assessment. AI integration supports human expertise, reduces errors, and increases biomarker availability, facilitating faster, more accurate clinical trial decisions and personalized medicine approaches. These innovations improve patient stratification, trial efficiency, and outcomes in drug development.
Network of Radiology Readers and Theraputic Area Experts
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Information Transparency and Acess to Experts
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Working together on Development of Your Clinical Protocol
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Technical advantages with DYNAMIKA
Real-time Access to Infrormation
We leverage advanced automation and information transparency through our award-winning DYNAMIKA platform. DYNAMIKA automates key imaging workflows—such as anonymization, quality control, and central image review—reducing manual tasks, improving reproducibility, and streamlining trial operations
Site Burden Reduction
Design and personalize AI interactions, map dialogue paths, predict customer needs, and automate responses to ensure relevant, human-like conversations.
Reader Discrepancy Management
IAG’s DYNAMIKA platform streamlines Reader Discrepancy Management by automating image workflows, centralizing data, and supporting double reads with expert adjudication. Integrated AI tools and real-time quality control enhance consistency, accelerate resolution of discrepancies, and ensure reliable, high-quality imaging results for clinical trials. IAG ensures accurate and reliable imaging results through robust Reader Discrepancy Management. Utilizing double reads and expert adjudication, discrepancies are promptly identified, reviewed, and resolved, enhancing data quality and trial integrity. Continuous monitoring and training further minimize variability and support consistent, high-quality clinical trial outcomes.
Private cloud deployments
We’ll host your trial data and sensitive data within your private cloud infrastructure, ensuring enhanced security, greater control, and full customization over your systems. Available for enterprise clients.
Deployment of AI Tools in Your Trials
The platform integrates advanced AI-driven methodologies to enhance the speed and reproducibility of radiological reads, enabling faster extraction of quantitative imaging data and early evidence of treatment efficacy.
Operational Excellence
Project and Data Management
Processing and responding to user queries in real-time, delivering instant personalized answers across phone calls and voice on websites and mobile apps.
Dedicated Support for the Sites and Investigators
Provide nonstop service to customers anytime, no matter their inquiry volume, language, location, or the device they’re using.
Strategic Alliances
IAG alliances with major CROs and innovative Ai Endpoint Partners
Multilingual Support
The AI personalizes interactions by using data from past conversations, preferences, and behavior to offer customized responses and recommendations and smoothly transfers calls to a live human agent when complex issues arise.
Geographical Reach
Working with 10,000 sites world wide, readers – world wide, incluyding operations in Cinala, USA, UK, EU, etc
Request Expert Call
Check your ideas and imaging endpoint strategy with our experts.
What we can do for You:
Publicly Announced Partnerships
see: https://www.ia-grp.com/strategy/
What clients say about
Image Analysis Group
Talk to our AI Team
Learn how our AI team can power your clinical trial or real-world evidence study, learn about our experience with global pharma companies, academic collaborators and international consortiums.
More Questions About Image Analysis Group?
What is Image Analysis Group’s experience in managing imaging for clinical trials?
Image Analysis Group (IAG) is a global leader in imaging clinical research, with nearly two decades of experience supporting biotech and pharmaceutical companies in optimizing and delivering clinical trials that rely on advanced medical imaging. Since 2007, IAG has successfully managed imaging for over 700 clinical trials across all phases (I-III), empowering sponsors to accelerate drug development and make confident, data-driven decisions.
Key Strengths and Experience:
Comprehensive Trial Support: IAG expertly manages all aspects of imaging in clinical trials, from study design and site setup to image acquisition, central review, and regulatory submission. Their experienced project managers ensure seamless execution and timely delivery, even in complex, multi-center global trials.
Proprietary Technology: IAG’s award-winning DYNAMIKA platform streamlines imaging data management, offering real-time quality control, advanced analytics, and AI-driven endpoints. This enables efficient data handling, accelerates patient recruitment, and provides sponsors with instant visibility into trial progress.
Therapeutic Breadth: IAG has deep expertise across a wide range of therapeutic areas, including oncology, immunology, rheumatology, neurology, rare diseases, obesity, and more. Their in-house radiology and medical experts ensure that imaging endpoints are tailored to the unique needs of each indication, maximizing the value of every trial.
AI-Powered Innovation: By integrating proprietary AI and machine learning tools, IAG delivers more sensitive and reproducible imaging endpoints, enabling earlier and more accurate assessments of drug efficacy and safety. This approach has been proven to reduce the number of patients needed and achieve statistically significant results faster, as demonstrated in published case studies.
Global Reach and Quality: With operational teams and partners across the UK, EU, USA, India, China, and Australia, IAG provides comprehensive support for international trials. Their rigorous quality management system is certified to the highest industry standards, ensuring data integrity and regulatory compliance at every step.
Proven Results:
IAG has a track record of helping sponsors achieve faster study outcomes, cleaner data for regulatory submissions, and reduced investment risk. Their collaborative approach and innovative solutions have delivered measurable value in high-profile partnerships and challenging therapeutic areas.
Why Choose IAG for Your Imaging Clinical Trials?
Partnering with Image Analysis Group means leveraging world-class expertise, state-of-the-art technology, and a commitment to operational excellence. Whether you are running early-phase exploratory studies or large-scale pivotal trials, IAG’s tailored solutions will maximize your trial’s success and accelerate your path to market.
Contact IAG today to discover how their imaging expertise can transform your clinical development program.
How many years has IAG been operating, and what is its track record in supporting biotech and pharma companies?
With nearly two decades of experience, a robust portfolio of successful partnerships, and a reputation for delivering high-quality, AI-powered imaging solutions, IAG is uniquely positioned to support biotech and pharma companies in achieving faster, more reliable clinical trial outcomes. Partnering with IAG means gaining a collaborative, expert-driven approach that de-risks clinical development and accelerates the path to market for novel therapies
Image Analysis Group (IAG) has been operating since 2007, giving the company over 17 years of experience as of 2025. Throughout this time, IAG has established itself as a trusted partner to biotech and pharmaceutical companies worldwide, specializing in the management of imaging for clinical trials across all phases (I-III) and a broad range of therapeutic areas.
Track Record Highlights:
Extensive Experience: IAG has supported hundreds of clinical trials, leveraging its award-winning DYNAMIKA platform and proprietary AI-driven methodologies to optimize trial design, accelerate data analysis, and ensure regulatory compliance.
Global Reach: The company operates internationally, with teams and partnerships spanning the UK, EU, USA, India, China, and Australia, enabling efficient support for global, multi-center trials.
Proven Results: IAG has a strong history of successful collaborations with leading biotech and pharma companies, providing critical imaging collection, centralized analysis, and expert assessment. Their expertise has been instrumental in advancing drug development programs, particularly in complex indications such as oncology, neurology, immunology, and rare diseases.
Innovation and Impact: By integrating advanced AI and quantitative imaging, IAG delivers more sensitive and reproducible endpoints, reducing patient numbers and timelines, and ultimately lowering investment risk for sponsors.
Industry Recognition: IAG’s commitment to innovation and operational excellence has been recognized through industry awards, including the 2024 Pharmaceutical Technology Excellence Award for its DYNAMIKA platform.
What therapeutic areas and indications does IAG have expertise in (e.g., oncology, immunology, neurology, rare diseases, obesity, bone health)?
Therapeutic Areas and Indications of IAG Expertise
Image Analysis Group (IAG) offers deep expertise across a wide spectrum of therapeutic areas and indications, making it a preferred imaging partner for biotech and pharmaceutical companies seeking to optimize clinical trials with advanced imaging solutions.
Core Therapeutic Areas:
Oncology:
IAG has a significant focus on oncology, with nearly one-third of its clinical development experience dedicated to solid tumors, lymphomas, and brain tumors. The team is experienced in early and late-phase trials, including umbrella, adaptive, and basket trial designs, providing comprehensive imaging services and central review for cancer studies.
Immunology and Autoimmune Diseases:
IAG supports trials in immunology and autoimmune conditions, leveraging AI-powered imaging endpoints to enhance safety and efficacy assessments.
Neurology and CNS Disorders:
The group has substantial experience in neuroscience, including neuro-oncology, neurodegenerative diseases (such as Alzheimer’s), and CNS disorders. Advanced imaging techniques are used for precise volumetric and vascular assessments, enabling sensitive tracking of disease progression and therapeutic response.
Rheumatology and Musculoskeletal Disorders:
IAG is recognized for its expertise in rheumatology and musculoskeletal trials, including osteoarthritis, cartilage repair, and pain studies. The team uses MRI, CT, and X-ray to quantify structural changes and inflammation, supporting both efficacy and safety endpoints.
Obesity and Metabolic Disorders:
IAG’s proficiency with DXA and other imaging modalities enables precise measurement of lean mass, fat mass, and bone density—critical for obesity and metabolic disorder trials. The group has supported large-scale registrational studies and early-phase projects in obesity, sarcopenia, and related indications.
Bone Health and Osteoporosis:
IAG specializes in imaging for bone health, osteoporosis, and spinal fusion trials, using DXA, MRI, and X-ray to deliver robust safety and efficacy data. Their expertise includes patient stratification strategies that can reduce trial length and costs.
Rare Diseases:
The team has a proven track record in rare disease trials, designing imaging endpoints that address the unique challenges of these indications and supporting sponsors through all phases of development.
Additional Areas:
IAG also supports studies in respiratory, ophthalmology, radiopharmaceuticals, and other specialty indications, adapting imaging strategies to meet specific trial needs.
Can you provide case studies or references from previous clients?
Case Studies and Client References
Image Analysis Group (IAG) has a strong track record of successful collaborations with leading biotech and pharmaceutical companies, demonstrated through a range of published case studies and client testimonials.
Selected Case Studies:
Ferring Pharmaceuticals – Women’s Reproductive Health:
IAG partnered with Ferring Pharmaceuticals to leverage AI-driven medical image analysis, advancing research in women’s reproductive health. This collaboration utilized IAG’s DYNAMIKA platform to efficiently handle large imaging datasets and uncover insights that traditional analysis might miss. Dr. Philippe Pinton, Senior Vice President at Ferring, highlighted the value of IAG’s AI-driven approach in unveiling hidden patterns and relationships within complex data.
Inflammatory Bowel Disease & Psoriatic Arthritis:
IAG has supported the development of breakthrough therapies for inflammatory bowel disease and psoriatic arthritis by applying advanced imaging analytics to better understand drug efficacy and support clinical decision-making.
Metastatic Melanoma and Immuno-Oncology:
IAG collaborated on the development of novel, targeted T-cell enhancing immuno-oncology therapeutics, applying AI-driven imaging strategies to support clinical trial programs in metastatic melanoma and other cancer indications.
Rare Disease – Turning Phase III Failure into Success:
In a notable case, IAG helped a global pharmaceutical company rescue a Phase III rare disease trial that initially failed to meet its endpoints. By re-analyzing imaging data with innovative methodologies, IAG addressed challenges related to data standardization and quality across nearly 250 global sites, ultimately enabling the sponsor to achieve statistically significant efficacy results faster.
Knee Osteoarthritis and Bone Health:
IAG’s AI-driven imaging analytics have been used to support clinical trial programs in knee osteoarthritis, providing sensitive endpoints and supporting both efficacy and safety assessments.
Industry Recognition:
IAG’s DYNAMIKA platform, central to many of these case studies, won the 2024 Pharmaceutical Technology Excellence Award for innovation, underscoring its impact on trial efficiency, data quality, and reproducibility.
Client Endorsements:
“The collaboration with IAG exemplifies our dedication to AI-driven research and development… harnessing AI to reveal deeper insights and bring the joy of delivering a healthy baby to women around the world.”
— Dr. Philippe Pinton, Senior Vice President, Ferring Pharmaceuticals
How many clinical trials has IAG supported to date?
Image Analysis Group (IAG) has supported over 700 clinical trials since its founding in 2007, delivering imaging expertise and advanced technology solutions for biotech and pharmaceutical companies globally. This extensive track record spans all phases of clinical development and a wide range of therapeutic areas, demonstrating IAG’s proven ability to optimize imaging in clinical trials and accelerate the path to regulatory success for novel therapies
How does the DYNAMIKA platform work, and what are its key features for clinical trial imaging?
How the DYNAMIKA Platform Works and Its Key Features for Clinical Trial Imaging
DYNAMIKA is Image Analysis Group’s award-winning, cloud-based platform designed to streamline and optimize imaging in clinical trials. It serves as a central hub for managing, analyzing, and reviewing imaging data, supporting trials from Phase I to IV across a range of therapeutic areas.
How DYNAMIKA Works:
Centralized Data Management:
DYNAMIKA integrates imaging data from multiple global sites into a single, secure, and manageable database. This enables real-time access and oversight for all trial stakeholders, including sponsors, project managers, and site staff.
Automated Workflows:
The platform automates key imaging processes such as data anonymization, quality control, and audit trails. This reduces manual workload, minimizes site burden, and ensures data security and regulatory compliance (21 CFR Part 11, ISO 13485, SOC II Type I).
AI-Driven Analytics:
DYNAMIKA incorporates advanced AI and machine learning tools to enhance image analysis, power quantitative endpoints, and enable earlier, more sensitive detection of treatment effects. This supports faster, data-driven decision-making and helps sponsors identify efficacy signals sooner.
Central Reads and Quality Control:
The platform enables centralized imaging quality control and radiological review, promoting consistency, accuracy, and reproducibility across global trials.
User-Friendly Interface:
DYNAMIKA’s intuitive design simplifies imaging workflows, making it easy for sites to upload, process, and manage imaging data, and for sponsors to monitor trial progress and performance.
Key Features for Clinical Trial Imaging:
Feature Description
Cloud-Based, Global Access Secure, real-time access for all stakeholders, supporting multi-center international trials
Automated Anonymization Built-in tools to redact personally identifiable information and ensure data privacy
Centralized Quality Control Automated and manual QC processes for consistent, high-quality imaging data
AI-Powered Analytics Embedded AI/ML tools for advanced image analysis and sensitive endpoint development
Regulatory Compliance Developed to meet FDA (21 CFR Part 11), ISO 13485, and SOC II Type I standards
Streamlined Workflows Automation of data ingestion, QC, and audit trails to reduce site and sponsor workload
Central Reads Facilitates blinded, centralized radiological review for unbiased efficacy and safety assessment
Real-Time Trial Oversight Instant visibility into trial status, data quality, and site performance
Data Interoperability Seamless integration and consolidation of imaging and operational data
Award-Winning Innovation Recognized as a 2024 Pharmaceutical Technology Excellence Award winner for driving industry change
Impact and Value:
Accelerates trial timelines by reducing manual processes and enabling earlier interim analyses.
Improves data quality and regulatory readiness through standardized, validated workflows.
Enhances operational efficiency for both sites and sponsors, reducing costs and resource requirements.
Supports complex, global trials in oncology, neurology, rheumatology, and beyond with proven reliability.
DYNAMIKA is trusted by leading biotech and pharma companies to deliver high-quality, reproducible imaging data and actionable insights—empowering confident, data-driven decisions throughout the clinical trial lifecycle
How does IAG leverage AI and advanced analytics in image review and endpoint assessment?
Image Analysis Group (IAG) is at the forefront of integrating artificial intelligence (AI) and advanced analytics into clinical trial imaging, transforming how image review and endpoint assessment are performed for biotech and pharmaceutical sponsors.
Key Approaches and Capabilities:
AI-Powered Endpoints:
IAG utilizes advanced AI algorithms to analyze vast amounts of imaging data, enhancing both safety assessments and efficacy evaluations. These AI-driven endpoints accelerate the detection of treatment effects and improve the overall reliability of trial outcomes.
Automated and Quantitative Analysis:
Through partnerships and proprietary technologies, such as the DYNAMIKA platform, IAG automates data analysis and enables the extraction of biologically interpretable imaging biomarkers. This approach streamlines the identification of early treatment responses, optimizes patient selection, and supports forecasting of therapeutic outcomes with greater accuracy.
Radiomics and Pathomics Integration:
IAG combines radiomics (quantitative features from medical images) and pathomics (features from pathology images) with AI to uncover predictive insights that traditional methods may miss. This synergy allows for more nuanced and personalized assessments, particularly in oncology and complex indications like glioblastoma.
Early and Sensitive Detection:
By applying AI and quantitative imaging, IAG can identify subtle, early changes in disease progression or treatment response that are often undetectable by conventional imaging review. This is especially valuable in challenging indications where distinguishing true progression from pseudo-progression is critical.
Centralized, Blinded Reads:
IAG’s DYNAMIKA platform supports blinded, centralized image review, powered by AI-driven quality control and workflow automation. This ensures consistency, reduces variability, and enhances the reproducibility of imaging endpoints across global multi-site trials.
Regulatory-Grade Compliance:
All AI-powered analytics and image review processes are conducted within a framework that meets stringent regulatory standards (e.g., 21 CFR Part 11, ISO 13485), ensuring data integrity and regulatory acceptance.
Impact for Sponsors:
Accelerated Trial Timelines:
Automated analysis and early detection capabilities help sponsors reach interim and final endpoints faster, reducing trial duration and investment risk.
Improved Data Quality and Consistency:
AI minimizes human variability and enhances the accuracy of imaging-derived endpoints, leading to cleaner, more reliable data for regulatory submissions.
Enhanced Decision-Making:
Real-time analytics and predictive biomarkers enable sponsors to make informed, data-driven decisions throughout the clinical development process
How does your technology ensure data integrity, security, and compliance (e.g., SOC II, BSI certifications)?
By combining industry-leading certifications (SOC II, BSI, ISO 13485, 21 CFR Part 11) with advanced technology safeguards, IAG delivers a secure, compliant, and reliable environment for clinical trial imaging. These measures ensure that sponsors’ data is protected, regulatory obligations are met, and trial results are trustworthy—making IAG a dependable partner for global clinical development.
Image Analysis Group (IAG) prioritizes the highest standards of data integrity, security, and regulatory compliance in all aspects of clinical trial imaging. The DYNAMIKA platform, IAG’s award-winning cloud-based solution, is designed and operated to meet rigorous industry standards and certifications.
Key Measures and Certifications:
SOC II Type I Compliance:
DYNAMIKA has achieved SOC II Type I compliance, which demonstrates that the platform adheres to stringent security standards for protecting client and patient data. SOC II certification is recognized globally as a benchmark for operational security, risk management, and trust in handling sensitive information.
British Standards Institute (BSI) Certification:
The platform has been certified by the British Standards Institute (BSI) through a surveillance audit, further validating its robust quality management and security controls.
ISO 13485 and 21 CFR Part 11 Compliance:
DYNAMIKA is developed in line with ISO 13485, the internationally recognized standard for quality management systems in medical device design and manufacturing, and 21 CFR Part 11, the FDA’s regulation for electronic records and signatures. This ensures that all imaging data is managed, stored, and processed according to the strictest regulatory requirements.
Technology and Operational Safeguards:
Automated Data Anonymization:
The platform incorporates tools to automatically redact personally identifiable information, ensuring patient privacy and compliance with data protection laws.
Centralized Quality Control and Audit Trails:
DYNAMIKA automates quality control checks and maintains comprehensive audit trails, guaranteeing data integrity and traceability throughout the trial lifecycle.
Secure Cloud Infrastructure:
All imaging data is stored and managed in a secure, cloud-based environment with real-time access controls, supporting both global collaboration and robust data protection.
Consistent Regulatory Oversight:
Regular audits and surveillance by recognized bodies (such as BSI) ensure ongoing compliance and continuous improvement in security protocols
What is your global reach and presence? In which regions do you operate and support trials?
With operational teams, offices, and partnerships spanning the UK, EU, USA, India, China, Australia, and beyond, IAG offers comprehensive, reliable support for imaging clinical trials on a global scale. This extensive reach ensures that sponsors can confidently execute multi-center trials, access diverse patient populations, and benefit from world-class project management—wherever their research takes them.
Image Analysis Group (IAG) operates as a truly global imaging clinical research organization, supporting clinical trials for biotech and pharmaceutical clients across multiple continents and regions.
Key Regions of Operation:
United Kingdom (UK) and Europe (EU):
IAG’s headquarters and core operational teams are based in London, with a strong presence and project management capabilities across the UK and the broader European Union.
United States (USA):
The US is IAG’s fastest-growing market, reflecting rapid adoption of AI-driven imaging in clinical trials. IAG maintains offices and operational teams in the US, supporting a significant portion of its client base and trial activity.
Asia-Pacific:
IAG has established teams in India and partnerships in China and Australia, enabling effective support for trials throughout the Asia-Pacific region.
Africa and Other Regions:
The company’s reach extends to Africa and other regions. This expansive network allows IAG to manage and deliver trials in diverse regulatory and clinical environments.
Operational Highlights:
Global Site Network:
IAG maintains a well-connected network of clinical sites and radiology readers, enabling rapid site setup, efficient data collection, and seamless trial execution across borders.
International Revenue and Impact:
65% of IAG’s revenue comes from outside the UK, with the US as the leading growth region. This demonstrates IAG’s strong international footprint and ability to deliver results for clients worldwide.
Comprehensive Support:
IAG provides end-to-end imaging trial management for Phase I-III studies and real-world evidence projects, leveraging local expertise and global oversight to ensure regulatory compliance and operational excellence
How do you manage site set-up, radiology reader networks, and data collection across multiple geographies?
By leveraging a global site and reader network, expert project management, and the award-winning DYNAMIKA platform, IAG ensures rapid site set-up, consistent radiology review, and secure, efficient data collection for clinical trials anywhere in the world. This integrated approach accelerates timelines, enhances data quality, and supports successful trial outcomes for sponsors.
How IAG Manages Site Set-Up, Radiology Reader Networks, and Data Collection Across Multiple Geographies
Image Analysis Group (IAG) delivers seamless global clinical trial execution by combining a robust operational infrastructure, a well-connected network of sites and radiology readers, and its advanced DYNAMIKA platform.
Site Set-Up and Radiology Reader Networks:
IAG maintains a global network of clinical sites and radiology readers, enabling rapid site activation and efficient trial initiation in the USA, EU, UK, China, India, South America, and beyond.
Experienced project managers and operational teams, strategically located across key regions, oversee site feasibility, onboarding, and regulatory compliance, ensuring trials are launched efficiently and in accordance with local requirements.
The radiology reader network is integrated with the DYNAMIKA platform, supporting centralized, blinded reads and ensuring consistency and quality across all imaging assessments.
Data Collection and Management:
IAG’s DYNAMIKA platform is the backbone for global imaging data management, providing a cloud-based, secure hub for image collection, storage, and analysis.
DYNAMIKA automates critical processes, including image anonymization, quality control, and audit trails, minimizing manual workload at sites and ensuring data integrity and regulatory compliance (ISO 13485, 21 CFR Part 11).
The platform supports real-time data ingestion and centralized quality control, allowing project managers and sponsors to monitor trial progress and site performance instantly from anywhere in the world.
AI-driven workflows and digital assistance enhance site performance, streamline radiology reads, and reduce operational costs, while ensuring high reproducibility and data security.
Operational Excellence Across Geographies:
IAG’s global presence—with teams in the UK, EU, USA, India, China, Australia, and additional offices in Singapore, the Netherlands, and Nigeria—ensures comprehensive support for multinational studies and adaptation to diverse regulatory environments.
The company’s integrated approach, combining medical, technological, and operational expertise, guarantees that data collection and trial delivery are efficient, transparent, and tailored to each sponsor’s needs
What experience do you have supporting regulatory submissions with imaging endpoints?
IAG is a trusted partner for integrating imaging endpoints into clinical trials with a proven track record of supporting regulatory submissions globally. Their scientific expertise, combined with advanced technology and rigorous quality management, ensures that imaging data meets the highest regulatory standards, helping sponsors confidently navigate approval pathways and bring novel therapies to market.
Image Analysis Group (IAG) has extensive experience supporting biotech and pharmaceutical companies in preparing and managing imaging endpoints for regulatory submissions across clinical trial phases.
IAG collaborates closely with sponsors and regulatory experts to design imaging study protocols that align with regulatory expectations. This includes defining appropriate sample sizes, patient inclusion/exclusion criteria, imaging biomarkers, and trial endpoints tailored to the indication and regulatory requirements.
The company’s proprietary DYNAMIKA platform ensures clean, high-quality imaging data through automated workflows, quality control, and centralized blinded reads, which are critical for regulatory-grade submissions.
IAG’s imaging experts help sponsors achieve regulatory objectives by customizing and standardizing analysis criteria to maximize the chance of meeting trial endpoints and gaining regulatory approval.
In practice, IAG has supported clients through interim analyses and final submissions, including rare disease trials where imaging endpoints were pivotal in demonstrating efficacy and safety to regulators.
IAG’s nearly 20 years of experience and over 700 supported trials have enabled sponsors to produce robust, reproducible imaging data that regulators trust, reducing investment risk and accelerating drug development timelines
How do you ensure patient data privacy and security across your global operations?
By combining certified technology, strict adherence to global data protection laws, and transparent privacy practices, IAG ensures that patient data remains secure and confidential throughout every stage of a clinical trial—no matter where in the world the trial is conducted. This approach not only protects participants but also builds trust with sponsors and regulatory authorities, supporting the integrity and success of every study.
Ensuring Patient Data Privacy and Security Across Global Operations
Image Analysis Group (IAG) is deeply committed to safeguarding patient data privacy and security across its global clinical trial operations. This commitment is embedded in both its operational practices and technological infrastructure.
Key Measures IAG Takes:
Compliance with International Laws and Standards:
IAG ensures that all international transfers and processing of personal data comply with applicable laws, including GDPR in Europe and HIPAA in the United States. The company uses approved mechanisms such as Standard Contractual Clauses and equivalent safeguards for cross-border data transfers.
Certified Technology and Processes:
IAG’s DYNAMIKA platform is developed and operated in compliance with leading industry standards, including ISO 13485, 21 CFR Part 11, and is re-accredited by the British Standards Institute (BSI). These certifications validate that IAG’s data management processes meet stringent regulatory and quality requirements.
Robust Data Security Practices:
The company implements advanced security measures to protect personal data from unauthorized access, disclosure, alteration, or destruction. This includes secure cloud-based infrastructure, role-based access controls, automated data anonymization, and comprehensive audit trails throughout the data lifecycle.
Transparent Privacy Policy and Data Subject Rights:
IAG’s privacy policy clearly outlines how personal data is collected, used, and protected. Individuals have rights to access, correct, delete, or restrict the processing of their data, and IAG processes such requests in accordance with applicable laws.
Operational Safeguards Across Geographies:
With teams and operations in the UK, EU, USA, India, China, and Australia, IAG ensures that data protection practices are consistently applied across all regions. Clinical Trial Agreements (CTAs) with sites include tailored data protection provisions to address local legal requirements
Can your solutions be tailored to specific trial designs or sponsor requirements?
IAG’s solutions are never “one size fits all.” Through a combination of advanced technology, deep scientific expertise, and flexible operational support, IAG customizes every aspect of imaging trial delivery—empowering sponsors to address their unique challenges, maximize data value, and accelerate drug development.
Tailoring IAG Solutions to Specific Trial Designs and Sponsor Requirements
Image Analysis Group (IAG) specializes in delivering fully customized imaging solutions for clinical trials, ensuring each project meets the unique scientific, operational, and regulatory needs of the sponsor.
How IAG Tailors Its Solutions:
Flexible Technology Platform:
The DYNAMIKA platform is designed with individually configurable workflows and role-based data access, allowing sponsors to define processes, endpoints, and data management strategies specific to their study protocols and operational models. This flexibility supports a broad range of trial designs, from early exploratory studies to large, multi-center Phase III trials.
Therapeutic Area and Modality Expertise:
IAG’s in-house radiology and scientific teams work closely with sponsors to select the optimal imaging modalities (MRI, CT, PET, etc.) and biomarkers tailored to the mechanism of action, disease indication, and desired study outcomes. This ensures imaging endpoints are relevant, sensitive, and aligned with trial objectives.
Custom Image Analysis and Scoring:
IAG develops and deploys study-specific image analysis methodologies—including AI-powered and quantitative assessments—based on the therapeutic agent, trial phase, and regulatory requirements. This approach supports advanced endpoints, patient stratification, and early efficacy/safety readouts.
Operational Adaptability:
The IAG team provides global project management and site support, adapting operational workflows to the sponsor’s geographic footprint, regulatory landscape, and preferred site network. Rapid site set-up and integration with local clinical teams ensure seamless execution across regions.
Collaborative Design and Execution:
IAG partners with sponsors from protocol development through to data submission, offering strategic input on imaging study design, endpoint selection, and regulatory strategy. This ensures that the imaging component of each trial is optimized for scientific rigor and operational efficiency.
What is your pricing model, and how do you demonstrate value for investment?
IAG’s pricing is designed to be transparent, flexible, and aligned with the sponsor’s needs. By combining cost-effective solutions with industry-leading technology and expertise, IAG consistently delivers measurable value—helping clients achieve their clinical objectives faster, with lower risk and optimized investment.
Image Analysis Group (IAG) offers flexible, tailored pricing models to meet the specific needs of each sponsor and clinical trial. Pricing is typically structured based on:
The complexity and phase of the trial (Phase I–III, real-world studies)
The number of sites and patients involved
The imaging modalities and endpoints required
The level of customization and integration with sponsor systems
The scope of services (site set-up, data management, central reads, regulatory support, etc.)
IAG works collaboratively with clients to identify cost-saving measures and optimize budgets without compromising quality or compliance. This approach ensures sponsors receive a solution that aligns with their operational and financial objectives.
How IAG Demonstrates Value for Investment:
Accelerated Timelines:
IAG’s DYNAMIKA platform and AI-powered endpoints streamline data collection, quality control, and analysis, leading to faster trial start-up, database lock, and regulatory submission—ultimately reducing time-to-market for new therapies.
Operational Efficiency:
Automated workflows and centralized data management reduce manual workload for sites and sponsors, minimize errors, and ensure clean, regulatory-ready data.
Risk Reduction:
Nearly 20 years of experience and a proven track record in over 700 trials help sponsors de-risk their clinical development by ensuring robust imaging data and reliable study outcomes.
Customization and Transparency:
IAG’s solutions are highly customizable, with real-time reporting and flexible options that provide transparency and accountability throughout the trial lifecycle.
Global Reach and Expertise:
With operational teams and site networks across the UK, EU, USA, India, China, and Australia, IAG supports efficient global trial delivery, maximizing patient recruitment and data quality.
How does working with IAG help de-risk clinical development and maximize ROI for sponsors?
Working with IAG means leveraging world-class imaging science, advanced AI, and proven operational excellence to de-risk your clinical trials, accelerate timelines, and maximize the value and ROI of your drug development programs.
How Working with IAG De-Risks Clinical Development and Maximizes ROI for Sponsors
Partnering with Image Analysis Group (IAG) provides biotech and pharmaceutical sponsors with a comprehensive approach to de-risking clinical development and maximizing return on investment (ROI).
Key Ways IAG De-Risks Clinical Development:
Early and Objective Efficacy Assessments:
IAG’s expertise in medical imaging and AI enables early detection of drug efficacy and patient response, often as early as Phase I. This allows sponsors to make informed go/no-go decisions, reduce exposure to non-viable candidates, and accelerate promising assets through development.
Tailored Imaging Endpoints:
IAG works closely with sponsors to select and implement the most appropriate imaging modalities (MRI, CT, PET, etc.) and endpoints for each trial. Smartly chosen imaging endpoints support patient stratification, early efficacy and safety readouts, and can predict drug response at earlier timepoints—enhancing trial enrichment and success rates.
Advanced AI and Predictive Analytics:
Leveraging the DYNAMIKA platform, IAG deploys AI-driven analytics and quantitative imaging biomarkers to uncover subtle treatment effects and predict outcomes. This approach reduces variability, supports precision medicine, and enables more confident decision-making.
Centralized, High-Quality Data Management:
IAG’s centralized, blinded image review and rigorous quality control ensure data integrity and reproducibility—critical for regulatory submissions and asset valuation.
Accelerated Timelines and Cost Savings:
Automated workflows, smart patient recruitment, and predictive analysis streamline trial operations, reduce manual workload, and minimize costly delays. This operational efficiency translates directly to faster study outcomes and lower overall trial costs.
Risk-Sharing and Bio-Partnering Models:
IAG offers flexible partnering models, including risk-sharing arrangements, to align incentives and support sponsors’ strategic and financial goals.
How IAG Maximizes ROI for Sponsors:
Increases Probability of Success:
By providing robust, early efficacy data and reducing trial failure rates, IAG helps sponsors focus resources on the most promising assets, enhancing portfolio value.
Supports Early Asset Acquisition and Licensing:
High-quality imaging data and early efficacy signals can lead to earlier asset acquisition or licensing opportunities, even before trial completion, maximizing commercial potential.
Reduces Investment Risk:
Predictive analytics and objective endpoints lower the risk of late-stage trial failures and ensure sponsors invest in assets with the strongest evidence base
Can you provide an overview of Image Analysis Group’s corporate background, including its history, leadership, structure, global presence, and core competencies that position it as a trusted partner in clinical trial imaging?
Image Analysis Group (IAG) is a leading global imaging contract research organization (CRO) founded by Dr. Olga Kubassova, a mathematician and PhD computer scientist, whose visionary work during her doctoral studies in Leeds, UK, laid the foundation for the company’s innovative approach. Dr. Kubassova, who currently serves as President, has been the driving force behind IAG since its inception, growing it from a start-up focused on novel image analysis algorithms to a trusted partner for biotech and pharma companies worldwide. She is recognized for her passion for innovation in life sciences, has authored over 120 scientific publications, and is a multiple-time recipient of national and international “Entrepreneur of the Year” awards.
Headquartered in London, IAG operates globally, delivering central imaging services and advanced analytics across North America, Europe, and Asia. The company is privately owned and led by an experienced executive team, including Dr. Kubassova as President and Roughan Sheedy as CEO, supported by leaders in operations and product development. IAG’s core competencies include designing and managing imaging endpoints for clinical trials, deploying proprietary AI-powered platforms like DYNAMIKA, and providing regulatory-compliant, high-quality data to accelerate drug development. The company’s commitment to scientific excellence, operational flexibility, and collaborative partnerships has established its reputation as a trusted leader in imaging for clinical research.
How does Image Analysis Group integrate innovation, compliance, and operational flexibility into its services to address complex challenges in clinical trials while ensuring data security and stakeholder value?
IAG’s foundation in mathematics and computer science, stemming from Dr. Olga Kubassova’s pioneering research, drives its culture of innovation and continuous improvement. The company has developed proprietary technologies, most notably the DYNAMIKA platform, which leverages artificial intelligence and advanced analytics to streamline image data collection, processing, and central review for clinical trials. This platform enhances data accuracy, reproducibility, and speed, helping clients bring novel therapies to market faster.
Compliance and data security are integral to IAG’s operations. The company adheres to international regulatory standards (FDA, EMA, ICH GCP) and maintains rigorous data privacy protocols, including SOC2 and ISO certifications, ensuring the highest standards of patient data protection and regulatory readiness. IAG’s regulatory experts support clients through every phase of clinical development, from study design to regulatory submission.
Operational flexibility is a hallmark of IAG’s approach. The company customizes its services to each client’s needs, adapts rapidly to protocol changes, and manages global projects through a network of expert radiologists and world-class project managers. By combining scientific expertise, cutting-edge technology, and a commitment to quality, IAG consistently delivers value to stakeholders—reducing risk, supporting efficient trial execution, and maximizing return on investment for sponsors.
Tell me about Imaging in Early Phase Trials
Key Roles of Imaging in Early Phase Trials
Safety and Efficacy Assessment: Imaging modalities such as CT, MRI, PET, and ultrasound are used at baseline and at regular intervals to monitor tumor response, disease progression, or stability. This helps researchers determine whether a drug is shrinking tumors, stabilizing disease, or causing adverse effects.
Pharmacodynamic and Pharmacokinetic Insights: Advanced imaging techniques (e.g., dynamic contrast-enhanced MRI, diffusion-weighted MRI, PET imaging) can provide early evidence of drug activity, such as changes in tumor vascularity or metabolic activity, which may not be apparent with traditional size measurements alone.
Biomarker Integration: Early phase trials increasingly incorporate imaging biomarkers—quantitative measures derived from images that serve as indicators of drug effect, disease state, or patient stratification. The selection, validation, and use of these biomarkers require close collaboration between clinical and laboratory teams and careful planning to ensure the biomarker is fit-for-purpose for the trial’s objectives.
Dose Finding and Decision Support: Imaging helps identify the optimal dose by providing real-time, non-invasive feedback on biological activity and potential efficacy, supporting decisions about whether to advance a drug to later trial phases.
Standardization and Centralization: Because early phase trials are typically small and often conducted at a limited number of centers, imaging protocols can be tightly standardized, enabling the use of more complex or novel imaging methods and reducing variability.
Operational Considerations
Centralized Imaging Platforms: The use of cloud-based, centralized imaging review platforms (like IAG’s DYNAMIKA) allows for timely, standardized, and accurate image analysis, which is crucial in early phase studies where protocols and endpoints may evolve rapidly.
Flexibility: Early phase studies often face changing scopes and endpoints. Flexible imaging solutions enable adaptation to new scientific questions or regulatory requirements as the trial progresses.
Data Quality: High-quality, standardized imaging data is essential to ensure reliable assessment of safety and efficacy, and to maximize the value of the trial for future development.
Tell me about Imaging Component of the Late Phase Trials
Imaging in late phase clinical trials—primarily Phase III and sometimes large Phase IIb studies—plays a crucial role in generating robust, standardized evidence of a drug’s efficacy and safety across large, diverse patient populations. These trials are pivotal for regulatory approval and market access.
Key Roles of Imaging in Late Phase Trials
Primary and Secondary Endpoints: Imaging is often used to define and assess primary and secondary endpoints, such as progression-free survival, objective response rate, and time to progression. These are typically based on standardized criteria like RECIST for solid tumors, using measurements of lesion size and disease burden.
Standardization and Reproducibility: Imaging protocols in late phase trials are highly standardized to ensure consistency across hundreds of sites and thousands of patients. Most Phase III solid tumor trials rely on CT scans for over 90% of evaluations, with MRI and sometimes PET/CT or bone scans supplementing anatomical assessments.
Regulatory Acceptance: Imaging biomarkers are increasingly accepted by regulatory agencies (FDA, EMA) as surrogate endpoints, especially in fast-track or accelerated approval pathways. This can reduce trial duration and costs, particularly for orphan and life-threatening diseases.
Operational Efficiency: In late phase trials, the focus shifts to efficient trial management and streamlined workflows to facilitate regulatory submission and approval. Centralized imaging platforms and rigorous quality control are essential to handle the scale and complexity of multinational studies.
Types of Imaging and Criteria Used
Conventional Imaging: CT and MRI are the mainstays, used for anatomical measurements and response assessment according to established criteria (e.g., RECIST).
Functional and Molecular Imaging: PET/CT, DCE-MRI, and DW-MRI may be used in select cases, but their widespread adoption in Phase III is limited due to standardization, cost, and validation challenges. FDG-PET is the most commonly used functional imaging modality in late phase oncology trials.
Imaging Biomarkers: When used as primary endpoints, imaging biomarkers must be “scientific grade” and handled with rigorous methodology to ensure data reliability and regulatory acceptance.
Benefits of Imaging in Late Phase Trials
Provides objective, reproducible evidence of drug efficacy and safety across diverse populations.
Enables faster and more cost-effective trials when imaging biomarkers are accepted as surrogate endpoints.
Supports regulatory submissions with high-quality, standardized data.
Facilitates patient stratification and subgroup analyses.
Challenges
Implementing advanced or functional imaging techniques at scale is difficult due to variability in equipment, protocols, and expertise across sites.
Ensuring data quality and consistency requires centralized review, robust training, and ongoing quality assurance.
Imaging in RWE studies
Imaging in Real-World Evidence (RWE) Studies
Imaging has become a cornerstone in real-world evidence (RWE) studies, providing objective, visual data that complements traditional clinical and claims data. RWE studies use data from routine clinical practice—including electronic health records, insurance claims, patient registries, and, increasingly, medical imaging—to evaluate how interventions perform in broader, more diverse populations outside the controlled environment of randomized clinical trials.
Key Roles of Imaging in RWE Studies
Objective Ground Truth: Imaging provides visual, objective evidence of disease presence, progression, and response to treatment. Unlike clinical notes or lab values, images serve as “ground truth,” allowing direct observation of anatomical or pathological changes and supporting more accurate diagnoses and outcome assessments.
Tracking Disease Over Time: Serial imaging enables researchers and clinicians to monitor changes in disease status, such as tumor growth or remission, in real-world settings. This is crucial for understanding long-term outcomes and treatment effectiveness.
Broader, More Representative Data: RWE imaging studies include diverse patient populations, reflecting real-world demographics, comorbidities, and care patterns. This enhances the generalizability of findings compared to traditional clinical trials, which often have strict inclusion/exclusion criteria.
Biomarker Discovery and Validation: Real-world imaging data can be used to identify and validate imaging biomarkers, which serve as objective endpoints for disease progression or therapeutic response. These biomarkers can be integrated with genomic and clinical data for deeper insights.
Regulatory and Clinical Decision Support: Regulatory agencies, including the FDA, increasingly recognize imaging as a valid source of RWE to support post-market surveillance, label expansions, and safety monitoring. Imaging data can also inform clinical guidelines and decision-making.
AI and Machine Learning: Large, standardized imaging datasets from real-world sources are essential for developing and validating AI/ML algorithms. These tools can improve diagnostic accuracy, workflow efficiency, and resource allocation in clinical practice.
Benefits of Imaging in RWE Studies
Speed and Scale: Access to vast amounts of imaging data from routine care enables larger, faster studies than traditional trials, supporting rapid evidence generation and public health responses.
Cost-Effectiveness: Leveraging existing imaging data reduces the need for new, expensive prospective trials.
Comprehensive Patient View: Imaging fills gaps left by other data sources, providing a holistic view of patient health and supporting the discovery of incidental findings that may impact care.
Challenges
Data Standardization: Variability in imaging protocols, equipment, and reporting across sites can complicate data harmonization and analysis.
Data Privacy and Security: Ensuring patient confidentiality and compliance with regulations (e.g., HIPAA, GDPR) is essential.
Bias and Generalizability: AI models trained on real-world imaging data can exhibit demographic or site-specific biases, which must be addressed to ensure fair and accurate results.
Summary Table: Imaging in Real-World Evidence Studies
Feature Description
Data Sources Routine clinical imaging (CT, MRI, X-ray, PET), EHR, registries, claims
Main Uses Disease tracking, biomarker discovery, AI development, regulatory support
Benefits Large, diverse samples; speed; cost savings; objective endpoints
Challenges Standardization, privacy, bias, data integration
Conclusion
Imaging in RWE studies enables researchers and clinicians to generate robust, generalizable insights into disease mechanisms, treatment effectiveness, and patient outcomes in real-world settings. When combined with clinical, genomic, and claims data, imaging provides a powerful foundation for evidence-based medicine, regulatory decision-making, and the advancement of AI in healthcare.