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| From designing first-in-human oncology studies to advancing gene therapies in rare diseases, Ergomed delivers integrated expertise across clinical development, CMC readiness, and regulatory strategy. Explore our latest insights on how early alignment, operational excellence, and scientific depth drive success in complex and advanced therapy trials. |
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Designing a first-in-human oncology study requires a balance of safety, speed, and scientific rigor. Explore how Ergomed’s global experts guide sponsors through dose-escalation strategies, adaptive designs, and patient-centric recruitment models. |
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Discover how Ergomed supported a multi-country immunotherapy program in a rare cancer population — demonstrating the value of flexibility, strategic monitoring, and patient engagement in complex oncology trials. |
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CMC readiness is often the missing link between preclinical discovery and IND submission. This checklist outlines how to anticipate regulatory expectations and build a compliant CMC strategy early. |
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Discover how Ergomed’s regulatory consultants guide gene therapy developers through pre-IND strategy, ensuring technical, quality, and clinical alignment for successful submissions. |
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Download our in-depth white paper exploring the evolving regulatory frameworks, scientific challenges, and clinical opportunities in the rare disease gene therapy landscape. |
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