Collect and Hold Solution
Dynamika by Image Analysis Group (IAG) is the perfect collect and hold solution for budget-conscious lifesceince companies that need to collect and securely store valuable imaging data while managing limited resources.
This affordable, cloud-based platform streamlines the entire process, making it simple and cost-effective to gather, store, and organize imaging data without the need for heavy upfront investment or complex infrastructure.
With Dynamika, biotechs benefit from scalable system that supports rapid setup and user-friendly site workflows, ensuring imaging data is managed efficiently and in full compliance with regulatory standards.
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
Why DYNAMIKA
Without integrated tools, teams struggle to oversee site performance, monitor patient safety, and catch issues early. More importantly, if you do not collect your images while your trial is ongoing, you will probably never see them. We provide budget friendly solution to collect (in real-time) and hold your imaging data, ready for centralized access and review by our radiology teams or with the use of A.I. tools.
What You Get with Collect & Hold
Centralized and Secure Image Repository
All imaging data are collected and safeguarded in a compliant, cloud-based platform, ensuring data security and regulatory adherence with standards like 21 CFR Part 11 and ISO 13485
Reduced Site Burden while Maintaining your Data
Imaging sites can easily upload their images to the cloud with minimal administrative load thanks to built-in automated workflows, anonymization, and quality control.
Future-Proofing for Regulatory or Scientific Review
Imaging data held centrally, enabling future independent reviews, analysis with AI / Quantitative methods or regulatory submissions without having to retrospectively chase the Sites after trial completes.
Efficient Transition to Central Review
Early-phase or exploratory studies can later upgrade to full central review or adjudication, since all data is already organized and available.
Accessibility and Fast Decision-Making
As required, Sponsors get instant, secure access to their imaging data, accelerating insights and supporting timely, strategic decisions throughout drug development.
Project Management and Site Support
Our team can support your sites and oversee study execution. We collaboratively work with the Sponsors to find the right level of balance between the costs and right level of oversight.
Image Quality Control
Images will be received on the cloud as soon as the Sites upload them. Our imaging specialists will log the images and can conduct real-time Quality Control of the data. This help ensuring the the data collected is of readbale quality and can be later reviewed by the radiologists.
Ready?
If you are planning a clinical trial that will use imaging to assess the safety and efficacy of your new drug candidate, share your challenges with our team.
Scope Definition and Proposal:
The biotech sponsor meets with IAG’s experts to outline the trial’s imaging requirements. IAG drafts a detailed scope, outlining roles, responsibilities, data types, imaging modalities, and compliance requirements. The proposal includes a project plan and a timeline for implementation.
Contracting and Project Kick-Off:
Both parties sign the agreement. IAG assigns a dedicated project manager and technical team to the study. A formal kick-off meeting is held to align stakeholders.
Site Onboarding and Training:
IAG provides participating imaging sites with DYNAMIKA access credentials (all their need is just internet connection) and training for uploading. Data is anonymized on upload.
Platform Configuration:
DYNAMIKA is configured for the trial, including user roles, image data workflows, automated QC, and secure cloud storage tailored to the Sponsor’s requirements. Sites conduct test uploads. IAG’s team verifies system readiness and solves issues.
Ongoing Data Collection and Hold:
Imaging sites begin uploading imaging data into DYNAMIKA. Real-time helpdesk and technical support ensure smooth operations. Data is collected, securely stored, and quality-checked throughout the trial. No images are reviewed or analyzed unless/until sponsor requests.
Data Access and Audit:
Sponsors receive regular status updates and, if needed, secure access to held data for internal review or regulatory queries. Complete audit trails are maintained.
Transition or Upgrade:
At trial end (or sponsor’s request), images can be released for analysis, central review, or future research—all fully traceable and regulatory-ready.
Case Studies
Case Study: Rapid Data Readiness in Rare Pediatric Brain Tumor Trial
A biotech company running an early-phase trial in a rare pediatric brain cancer faced uncertain regulatory requirements and evolving imaging endpoints. Partnering with IAG, they adopted DYNAMIKA’s collect and hold workflow. IAG streamlined site onboarding, standardized image uploads, and performed automated QC, ensuring all MRIs were securely stored and compliant. When regulators unexpectedly requested retrospective blinded review, all imaging data was instantly accessible and ready for analysis. This agility allowed the sponsor to address regulatory feedback promptly, keeping the study on track and building credibility with stakeholders.
Case Study: Robust Data for a Challenging Oncology Basket Trial
A sponsor conducting a multi-arm, basket trial in advanced solid tumors needed confidence that diverse imaging data—across multiple malignancies and imaging modalities—would be fully quality-controlled and ready for integrated analysis. IAG’s collect and hold solution with DYNAMIKA enabled seamless, real-time acquisition and storage of complex imaging datasets from over 30 global sites. When the company was acquired mid-study, the comprehensive imaging archive provided by IAG not only facilitated a smooth handover but also assured the new owners that all trial data could meet due diligence and regulatory requirements, maximizing asset value and de-risking future development.
Case Study: CAR-T Immunology Trial—From Single IND to Multiple Cohorts
A pioneering biotech launched its first CAR-T cell therapy clinical trial in immunology under a single IND, targeting a rare autoimmune disease. The company partnered with IAG to establish a robust collect and hold imaging workflow using the DYNAMIKA platform. Initially, only a handful of imaging sites were involved, and PET/CT and MRI data were centrally collected, anonymized, and quality-checked, then securely held for future review as endpoints matured. As the trial showed promising safety and efficacy signals, the sponsor rapidly expanded to multiple INDs and launched new cohorts in additional autoimmune and hematological indications. With IAG’s scalable support, DYNAMIKA’s platform accommodated the onboarding of new global sites and diverse imaging modalities. All new and existing cohorts’ data were seamlessly captured within the same secure, traceable infrastructure. When the sponsor needed to present interim results to regulators and design new trial arms, they could instantly access high-quality, audit-ready imaging data across all cohorts and indications. This flexible, future-proof approach enabled rapid regulatory responses, confident expansion into new disease areas, and consistent data integrity—ultimately accelerating development timelines and supporting the sponsor’s leadership in CAR-T immunology therapeutics.
Case Study: Osteoarthritis Study to Objectively Demonstrate Disease Modification
A leading biotech company developing a novel therapy for osteoarthritis faced the challenge of objectively demonstrating disease modification in early clinical trials across global sites. Partnering with IAG, they implemented a collect and hold imaging workflow leveraging DYNAMIKA. IAG guided site selection, onboarded imaging centers, and established standardized protocols for MRI and X-ray data collection, ensuring high-quality and consistent imaging across diverse locations. All images were de-identified, automatically quality-checked, and securely stored in the DYNAMIKA platform, allowing the sponsor to focus on patient enrollment without the immediate pressure of real-time analysis. When interim results attracted regulatory and investor interest, IAG rapidly mobilized centralized analysis using advanced AI-driven imaging biomarkers. Significant improvements in synovial inflammation were detected, supporting the therapy’s mechanism of action and enabling compelling data presentations. This approach gave the sponsor operational flexibility, regulatory confidence, and the ability to rapidly transition from data collection to robust centralized analysis as business needs evolved. Ultimately, this streamlined, future-proof imaging infrastructure helped accelerate decision-making, secure funding for late-phase trials, and demonstrated the therapy’s value in a highly competitive osteoarthritis landscape
Let Us Handle Your Data – So that You Have Control
Book a call to see how we can ensure reliable and compliant imaging data management in your trial.
What we can do for You:
Talk to IAG Team
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.