Late Phase and Pivotal Trials
In late phase and pivotal clinical trials, robust imaging data is vital for proving drug efficacy and safety. DYNAMIKA platform in Phase III delivers a global infrastructure for cloud-based image collection, quality control and central review through standardized workflows — ensuring that trial imaging data is audit-ready and regulatory compliant. Our radiology experts optimize imaging strategies, streamline site training to reduce disrepancies in image reviews. We help to think through effective strategies for advanced analytics and AI, which can run alongside primary and secondary image reviews, as your trial progresses.
With IAG and DYNAMIKA, Sponsors reduce risk, accelerate timelines, and secure reliable evidence, positioning their trials for regulatory approval and commercial success.
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
Working in Phase III with IAG
With IAG, sponsors benefit from global, standardized imaging workflows that ensure every scan meets rigorous regulatory and quality standards—critical for pivotal studies and product approvals. Our real-time, automated QC and seamless reader overights and adjudication mean imaging data is always audit-ready and inspection-friendly. IAG’s integrated analytics, AI solutions, and expert scientific consulting empower sponsors to unlock deeper insights, accelerate database lock, and meet even the most demanding submission timelines. Working with IAG ensures not only smoother study operations and minimized risk, but also robust, regulatory-ready imaging endpoints capable of driving market success and increasing asset value for your late-phase clinical development.
What You Get with IAG?
Global, Real-Time Imaging Data Capture:
Seamlessly collect, anonymize, and store imaging data from any site worldwide, supported by intuitive uploads and immediate quality control checks that prevent loss of critical data.
Instantaneous Quality Assurance:
Automated real-time QC ensures every scan is compliant and high quality, dramatically reducing rescan rates and site burden.
Accelerated Patient Safety Reviews:
Near-instant image availability for safety monitoring allows sponsors to assess and respond to potential adverse events sooner, protecting patients and supporting adaptive trial designs.
End-to-End Auditability and Regulatory Compliance:
Full traceability and secure data management keep every image inspection-ready, meeting 21 CFR Part 11, GDPR, and global regulatory requirements.
Advanced Imaging Analytics and AI Integration:
Leverage our cutting-edge quantitative imaging methods and validated AI tools for deeper insight into efficacy, patient subgroups, and drug efficacy—all within the same platform. We will help you think how to effectively deploy advanced image analysis alongside your primary and secondary reads.
Efficient Site and Study Management:
Streamlined workflows, centralized adjudication, and integrated eCRFs decrease admin time, minimize protocol deviations, and make database lock and submission faster.
Future-Proof Flexibility:
Robust infrastructure enables easy scaling from early to late phase, integration of new cohorts and geographies, and positions sponsors for rapid adaptation to evolving regulatory or scientific needs.
Site Feasibility and Protocol Review
Reach out to our team to discuss the imaging sections of your protocol and optimization of imaging endpoints in your trial. Start your Phase 3 confidently with IAG and DYNAMIKA: site capabilities review for imaging, phantom scan collection, site training and onboarding to support global data collection.
Protocol Review and Site Feasibility:
Understand trial goals, imaging endpoints, and site capabilities to plan study design and logistics effectively.
DYNAMIKA Platform Setup:
Customize DYNAMIKA workflows for data collection and central review. Provide continuous helpdesk assistance, generate real-time and interim reports, and adapt workflows and support as the trial progresses and needs evolve.
Site Qualification and Training:
Verify imaging equipment at each site, deliver comprehensive training sessions, and conduct test image transfers to ensure all sites are fully prepared.
Go-Live and Real-Time Data Collection:
Launch imaging data uploads with automated quality control checks and continuous central monitoring via DYNAMIKA.
Initiate Central Review
We centrally review images either in real time or in batches, maintaining a complete log of any reader discrepancies. All electronic case report forms (eCRFs) are integrated directly into the DYNAMIKA platform.
Case Studies
Case Study: Pivotal Oncology Trial—Reduced Imaging-Related Delays and Regulatory Readiness
In a pivotal phase III oncology trial with over 80 global sites, a major pharma company adopted IAG’s imaging solution to assure consistent data and rapid safety monitoring. Through DYNAMIKA, image uploads were QC’d within 12 hours, and protocol deviations related to imaging dropped by 40%. Centralized endpoint adjudication and eCRF integration resulted in database lock being achieved 22 days sooner than planned. This enabled the sponsor to submit a robust regulatory package on schedule, gaining faster EMA and FDA review.
Case Study: Rapid Site Activation and Patient Enrollment in a Rare Disease Trial
A biotechnology company developing a therapy for a rare neuromuscular disorder partnered with IAG for an international phase II imaging study. Leveraging IAG’s accelerated site feasibility assessments and DYNAMIKA’s protocol-driven setup, 18 sites across North America and Europe were onboarded in under four weeks—50% faster than previous industry benchmarks. Real-time imaging QC reduced rescans by 60%, enabling the sponsor to reach first-patient-in two months ahead of schedule and securing positive interim data for investor milestone payments.
Case Study: Seamless Early to Late Phase Transition in Bone Health
A sponsor developing a novel osteoporosis therapy began with a phase I/II trial using DYNAMIKA for standardized DXA and MRI data capture. As promising results emerged, their late-phase study scaled to 50+ sites on the same platform, with automated reporting streamlining interim analysis. Data integrity was maintained across all trial phases, and imaging cost-per-patient decreased by 35% compared to legacy platforms. This operational consistency and audit readiness facilitated rapid due diligence, supporting successful partnership negotiations and late-phase investment.
Case Study: Reversing Trial Failure in Autoimmune Disease with Centralized Imaging
A global pharmaceutical company faced a major setback when their phase IIb autoimmune disease trial failed to meet primary endpoints across 50+ sites, resulting in a 20% stock drop. Partnering with IAG for the repeat study, they adopted DYNAMIKA for centralized data management, advanced imaging analytics, and real-time operational oversight. Early, sensitive efficacy assessments empowered timely go/no-go decisions, and streamlined workflows reduced site burden and accelerated the trial timeline. This integrated approach improved data quality and enabled rapid, informed strategic moves, helping to regain leadership and restore investor confidence.
Case Study: Supporting Psoriatic Arthritis Global Development with AI-Driven Analytics and Advanced Imaginfg
In the phase IIIb trial, the power of advanced imaging and AI-driven analytics fundamentally reshaped psoriatic arthritis drug development. As the first multicenter study to deploy MRI as a sensitive tool for assessing joint and enthesis inflammation, Trial collected hand and whole-body MRIs from patients across 29 sites in ten countries. With support from IAG and its DYNAMIKA platform, imaging data were centrally managed, subjected to rigorous real-time quality control, and analyzed using sophisticated, standardized metrics like PsAMRIS and whole-body inflammation scores. Leveraging automated workflows and AI-driven image quantification, the study team was able to detect improvements in bone marrow edema, synovitis, and tenosynovitis far earlier and with greater objectivity than traditional assessments. This approach not only accelerated the identification of treatment response but also enabled deep exploration of inflammation patterns and patient subgroups, informing future trial designs and regulatory discussions. The use of centralized, technology-powered imaging management reduced time to interim readouts, supported higher data integrity, and ultimately delivered compelling evidence that apremilast improved inflammatory outcomes. This trial stands as a benchmark for the integration of advanced imaging and AI-driven endpoints in rheumatology clinical development, demonstrating the tangible impact of IAG’s scientific and platform solutions for sponsors seeking clarity, speed, and regulatory success.
Case Study: Accelerated Breakthrough Therapy Designation Via Advanced Imaging in Oncology
Collaborating with IAG, a sponsor developing an immuno-oncology asset used DYNAMIKA to standardize and centralize imaging data across 40 sites. Advanced radiomic analyses and integrated AI provided deep, early insights into responder populations, leading to the identification of a predictive biomarker. The team secured breakthrough therapy designation three months ahead of expectations. Faster regulatory dialogue and a robust clinical dataset increased the therapy’s acquisition value and supported successful strategic partnerships
Watch Video with our Chief Operating Officer Speaking about Late Phase Trials
What we can do for You:
Talk to a IAG 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.