Collect and Hold Solution

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™ 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.

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.

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™ 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.

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