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Discover how clinical trial success is being redefined through patient-centered design, strategic site support, and deep therapeutic expertise, from pediatric oncology to first-in-human studies.
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This guide outlines a patient-centric and risk-based approach to executing first-in-human (FIH) oncology trials while addressing key challenges, including regulatory complexities, patient recruitment limitations, academic site delays, and gaps in patient engagement.
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A pharmaceutical company faced significant hurdles in obtaining regulatory approval for its new treatment targeting NHL. Explore the collaboration that allowed them to address these challenges, underscoring the importance of strategic planning and regulatory engagement in the approval process.
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Dive into the history and accomplishments of Ergomed, a mid-sized, full-service contract research organization (CRO), with a strong reputation over 25 years through its specialized focus on oncology and rare disease clinical research.
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A biotechnology company encountered significant hurdles in launching a Phase 1 clinical trial for a novel therapy targeting a rare pediatric cancer. To overcome these obstacles, a strategic approach that was taken resulted in regulatory clearance for the trial, successfully balancing scientific rigor, ethical considerations, and practical feasibility.
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Early and transparent engagement between drug development companies and Patient Advocacy Organizations (PAOs) is essential to advancing rare disease research, enhancing clinical trial design and community trust.
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From our inception, Ergomed has been committed to enhancing the patient journey in clinical trials. Designed to address and resolve issues proactively, our unique Ergomed CARE™ approach supports and engages all stakeholders, leading to accelerated study start-up, improved patient recruitment and retention, and investigator engagement.
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