Tecartus
INTRODUCTION Tecartus is a new advanced therapy approved to treat adults with mantle cell lymphoma (MCL)¹. This disease is a lymphatic system cancer. Specifically, it
At Geistek Pharmaceuticals, we understand the importance of medical imaging in clinical trials and its potential to improve decision-making, increase efficiency, and potentially reduce trial costs. By partnering with a leading specialist provider like Geistek Pharmaceuticals, you can leverage our expertise and global capabilities to enhance your trial outcomes.
Our experienced team provides strategic advice on incorporating biomarkers in early phase development and demonstrates how medical imaging endpoints can provide objective evidence of a drug’s safety and efficacy. We offer guidance on imaging endpoints and the critical uses of imaging for the medical, scientific, and regulatory aspects of your trial, ensuring successful outcomes.
To further enhance our capabilities, we utilize industry-leading technology from Mint Medical as part of our expanded imaging analysis solutions. This includes advanced features such as radiomics, volumetrics, and AI technology, enabling us to deliver decreased timelines for read criteria while maintaining reliable, high-quality data in a consistent, compliant, comprehensive, and structured format.
With over 20 years of experience, our medical imaging team comprises industry-leading experts who have extensive knowledge across phases, therapeutic areas, and indications. Their expertise, combined with our proven best practices and access to our state-of-the-art MIRA technology, ensures data quality, accuracy, and accelerated clinical trial management.
We collaborate with top-rated hospitals and engage the best doctors who possess experience in all analysis criteria. This allows us to provide expert analysis and select the right readers for your trial based on study requirements, budget, and timelines. Our MIRA platform, integrated with protocol-specific eCRF, enables readers to access information securely from anywhere globally to perform various types of reads.
Furthermore, our senior experts actively engage with regulatory authorities, including the FDA’s Division of Medical Imaging and Hematology Products and therapeutic divisions, to provide regulatory insight on medical imaging endpoints. We participate in the development of industry standards through collaborations with organizations like the MCC, PhRMA, FDA, DIA, and Imaging Core Labs, ensuring compliance with charters and submissions.
By partnering with Geistek Pharmaceuticals for your medical imaging needs, you can benefit from our industry-leading expertise, advanced technology, and regulatory insights, resulting in improved decision-making, enhanced efficiency, and successful clinical development programs. Contact us today to explore how we can support your trial with our comprehensive medical imaging services.
INTRODUCTION Tecartus is a new advanced therapy approved to treat adults with mantle cell lymphoma (MCL)¹. This disease is a lymphatic system cancer. Specifically, it
INTRODUCTION Kymriah (Novartis) is an advanced therapy medicine that belongs to the gene therapyproduct category. It is approved for B-cell acute lymphoblastic leukemia (ALL) in
INTRODUCTION ¹. CARVYKTI™ (ciltacabtagene autoleucel – Johnson & Johnson) was approved by the U.S. Food and Drug Administration (FDA) in February 2022 for the treatment
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