DYNAMIKA™: Your One Stop for Clinical Trial Imaging.

Designed to accelerate the next wave of drug development for biopharma, CROs, and researchers. An AI-enabled platform that delivers faster, more reliable imaging endpoints, driving regulatory success and accelerating drug development.

 

 

Get a demo today

DYNAMIKA™: Redefining Imaging in Clinical Trials

Better Imaging, Better Outcomes

One solution for all your clinical trial imaging needs

Simplify complex data and image management through automated workflows.

Go faster
Streamline imaging workflows and reduce trial delays.

Gain transparency
Track site, reader, and CRO performance across all stakeholders in real time.

Make confident decisions
Leverage consistent, high‑quality imaging data for regulatory submissions.

Focus on what matters
Improve trial outcomes by eliminating complexity in imaging management.

Clinical Trial Paradigms

Configurations tailored to multiple clinical research needs

Collect and Hold

Centralized & Secure Data Collection
DYNAMIKA™ unifies global imaging into a secure, cloud-native platform. Fully compliant with 21 CFR Part 11 and ISO 13485 for regulatory readiness.

Real-Time Visibility & Oversight
Instant 24/7 access to imaging data for all stakeholders. Track site and reader performance to drive timely, informed decisions.

Quality Control & Automated Anonymization
Automated checks ensure high-quality, anonymized imaging datasets.Reduce errors, protect patient privacy, and safeguard trial integrity.

Seamless Data Integration & AI-Ready Infrastructure
Integrates easily with AI tools and analytics modules. Supports advanced endpoints and innovative trial methodologies.

Reduced Site Burden & Faster Trial Timelines
Simplified workflows lighten site workload and speed reviews. Fewer delays mean shorter trials and faster drug development.

Central Image Review

Consistent, Standardized Image Analysis
Centralized, protocol-driven reviews with automated checks. Delivers reproducible results and consistent clinical endpoints across sites.

Real-Time Collaboration & Audit Trails
All data and reviewer actions are logged centrally. Enables secure collaboration, transparency, and timely decisions.

Expert Review Efficiency & Reader Management
Simplifies reader assignment, monitoring, and workflow optimization.Reduces variability and flags outliers early in the process.

Integrated Advanced Analytics & AI Tools
Seamlessly connects with advanced analytics and AI modules.Gives reviewers faster access to biomarkers and novel endpoints.

Regulatory Compliance & Submission Readiness
Validated environment supporting 21 CFR Part 11 and ISO 13485. Ensures audit-ready data and smoother regulatory submissions.

Let’s Get Started

Our strategic collaborations give biotech and pharma teams access to powerful imaging data, operational excellence, and flexible trial designs, driving the next wave of drug innovation.

Contact Us

Why Partner With Image Analysis Group

Industry-Leading Expertise in Imaging Clinical Trials

IAG brings two decades of global experience in designing and executing imaging endpoints for Phase I-III studies, supporting biotech and pharma companies in oncology, immunology, neurology, and more

Advanced, AI-Powered Imaging Platform DYNAMIKA™

Benefit from DYNAMIKA™, our award-winning cloud-based platform for imaging data management, central review, and regulatory-grade analytics. Unlock early efficacy, robust safety insights, and transparency across stakeholders—accelerating development and maximizing trial success.

Global Site Network & World-Class Radiology Experts

Tap into IAG’s vast network of imaging sites, expert radiologists, and project managers across North America, EU, UK, India, and China for comprehensive support in both global and regional trials.

Accelerate Trial Timelines & De-Risk Development

With predictive imaging biomarkers and AI-powered endpoints, IAG helps sponsors achieve faster patient recruitment, real-time oversight, and rapid database lock, lowering R&D risks while improving trial outcomes.

Trust, Transparency, and Regulatory Compliance

Work with a partner trusted for hundreds of successful trials since 2007. IAG delivers validated processes, 21CFR Part 11 and ISO 13485 compliance, and transparent access to imaging data for confident regulatory submissions

Contact Us Today

speak to our expert team today

Frequently Asked Questions: 

What regulatory and data security standards does Image Analysis Group (IAG) adhere to?

21 CFR Part 11 compliant imaging platform and SOPs

Image Analysis Group (IAG) operates under rigorous regulatory and data security standards to support successful global drug development. The group combines certified infrastructure with proven regulatory experience to give Sponsors confidence at inspection and at the time of marketing submission.

Regulatory framework

IAG’s imaging platform DYNAMIKA™ and processes are designed to comply with 21 CFR Part 11 requirements for electronic records and electronic signatures, ensuring data integrity, traceability, and robust audit trails across all imaging workflows.

The organization also maintains SOC 2–aligned controls for security, availability, and confidentiality, demonstrating strong governance around data protection and system reliability.

Inspection readiness and track record

IAG has undergone two intensive mock FDA inspections, using these to stress‑test its quality system, refine documentation, and validate inspection readiness across operations, technology, and clinical delivery. These capabilities have contributed to the execution of pivotal and late‑phase trials whose results supported regulatory submissions and helped bring new products to market, reinforcing IAG’s role as a trusted long‑term partner for Sponsors.

What is Image Analysis Group’s (IAG) experience in managing imaging for clinical trials?

Central imaging experts and core lab for MRI, Xray, CT, DXA, PET and US

Image Analysis Group (IAG) is a trusted global leader in imaging clinical research, empowering biotech and pharmaceutical companies to accelerate drug development with expert imaging solutions. Since 2007, IAG has delivered over 700 successful trials across all phases, providing end-to-end support from study design and site setup to image acquisition, central review, and regulatory submission.

Our proprietary DYNAMIKA™ platform streamlines imaging data management with real-time quality control, advanced analytics, and AI-powered endpoints, enhancing trial efficiency and data transparency.

In addition, our in-house radiology and therapeutic experts design tailored imaging strategies for oncology, immunology, neurology, rare disease, and more, ensuring your trial’s imaging endpoints deliver maximum value.

With a quality-certified global network and published success in reducing sample sizes and accelerating timelines, IAG offers collaborative, innovation-driven partnerships that de-risk development and speed your product to market.

Contact our team to discuss your next upcoming clinical trial here: contact@ia-grp.com

Where is Image Analysis Group’s (IAG) global reach and in which regions do we operate and support clinical trials?

Phase II/III imaging vendor global reach

Image Analysis Group (IAG) provides truly global imaging clinical trial services, supporting biotech and pharmaceutical clients through operational teams, offices, and partnerships across the UK, EU, USA, India, China, Australia, Africa, and beyond. This global network enables Sponsors to run multi-center trials at qualified imaging sites and achieve rapid, confident study start-up in any region.

Headquartered in London, IAG delivers comprehensive project management for Phase I–III clinical trials and real-world evidence (RWE) studies. With dedicated teams in the USA, UK, EU, and India, and partner teams in China, we ensure seamless execution, strong local insight, and responsive communication.

Our extensive network of imaging sites and expert readers guarantees consistent, high-quality data collection around the world. Reach out to discuss imaging site networks and reader experience.

What imaging modalities and biomarkers can DYNAMIKA™ support (MRI, CT, PET, US, X ray, DXA, QCT, radiomics)?

DYNAMIKA™ is designed to support all key imaging modalities used in Phase 1–4 trials, including MRI, CT, PET, ultrasound, X‑ray, DXA, and quantitative CT (QCT).

Within these modalities, the platform can manage both qualitative reads and fully quantitative biomarkers, such as volumetric measurements, dynamic contrast‑enhanced parameters, bone density, and lesion‑level change over time. DYNAMIKA™ also enables radiomics and other advanced, AI‑ready biomarkers by standardizing acquisition, preprocessing, and feature extraction, so exploratory image‑based signatures can be developed alongside conventional endpoints.

All outputs are integrated into centralized review workflows and exported as analysis‑ready, regulator‑compatible data for use in primary, secondary, and exploratory endpoints.

How does Image Analysis Group (IAG) handle DXA imaging in trials?

Image Analysis Group (IAG) uses DXA as a quantitative, low‑dose tool to support both efficacy and safety endpoints in trials, particularly in bone health, osteoporosis, oncology, and obesity/metabolic programs.

The team designs DXA workflows covering acquisition parameters, site calibration with phantoms, and hardware‑specific harmonization for Hologic and GE systems to ensure reproducible bone mineral density and body composition measurements across global sites.

DXA endpoints such as BMD, vertebral fracture grading, trabecular bone score, and body composition metrics are integrated into imaging charters, centralized on DYNAMIKA™ for QC and review, and delivered as regulator‑ready datasets to inform fracture risk, skeletal safety, and treatment response.

How does DYNAMIKA™ help Sponsors use AI-powered or advanced analytics in trials?

DYNAMIKA™ provides an AI‑enabled imaging infrastructure that standardizes how images are collected, curated, and annotated, soSponsors can reliably plug in advanced analytics or third‑party AI tools without rebuilding workflows for each study. The platform supports integration of radiomics, predictive imaging signatures, and other quantitative biomarkers directly into central review, with full audit trails, version control, and 21 CFR Part 11‑aligned controls for any derived endpoints.

Through its “AI‑ready” architecture and APIs, DYNAMIKA™ allows sponsors to test, validate, and operationalize AI‑powered endpoints alongside conventional criteria, accelerating early signal detection and de‑risking the path to regulatory acceptance.

How does Image Analysis Group (IAG) core lab manage image acquisition, QC, and central reading across global sites with DYNAMIKA™?

Image Analysis Group (IAG) uses DYNAMIKA™ to manage the full imaging workflow across global sites, from acquisition to central read. Sites upload DICOM images directly into the cloud‑native platform, where automated anonymization and real‑time QC checks ensure protocol‑compliant data before reads are scheduled. Central reading is then conducted in DYNAMIKA™ using protocol‑driven workflows, reader assignment and monitoring tools, and complete audit trails, giving sponsors consistent, regulator‑ready endpoints and live visibility into site and reader performance.

How do Image Analysis Group (IAG) use AI and quantitative imaging to support endpoint assessment and decision making?

Image Analysis Group (IAG) designs endpoint strategies where AI and quantitative imaging are built in from the outset, not added late in development.

Using DYNAMIKA™, imaging data are curated in a way that supports robust extraction of volumetric, radiomic, and texture‑based biomarkers, enabling development of predictive or pharmacodynamic signatures that go beyond simple size measurements. These quantitative and AI‑enabled readouts are then aligned with clinical outcomes and protocol‑defined criteria, giving sponsors additional, regulator‑compatible evidence to refine go/no‑go decisions, inform dose and cohort selection, or shape subsequent trial designs.

Can DYNAMIKA™ integrate with my EDC, RTSM, eCOA, and safety systems?

Yes. DYNAMIKA™ is built to integrate with standard clinical systems, including EDC, RTSM/IWRS, eCOA, and safety databases, using validated interfaces and APIs. Image and endpoint data can be pushed or pulled in near real time, with mappings aligned to the study’s data model and 21 CFR Part 11 controls maintained end‑to‑end. This allows sponsors to keep imaging fully synchronized with randomization, clinical, and safety data, while preserving a single audit trail for regulatory inspection.

Can Image Analysis Group (IAG) support exploratory imaging, including radiomics and AI biomarker development?

Image Analysis Group (IAG) actively supports exploratory imaging, including radiomics and AI biomarker development, alongside conventional endpoints.

Using DYNAMIKA™, imaging data are curated with standardized acquisition, preprocessing, and annotations so feature‑level data (radiomics, texture, volumetrics) can be reliably extracted and linked to clinical outcomes. IAG’s scientific and data science teams work with sponsors to define hypotheses, derive and test image‑based signatures, and, where appropriate, operationalize promising AI or quantitative biomarkers as protocol‑defined exploratory or secondary endpoints in later‑phase studies.