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With an integrated strategy—combining protocol development, site engagement, and operational oversight— Ergomed enabled timely data reviews and adaptive trial modifications for the company. This partnership exemplifies the strategic value a CRO can bring to biotech sponsors navigating complex oncology development landscapes.
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This significant Phase III trial, one of the largest global studies in head and neck cancer with over 900 participants, was a Rescue study that faced considerable challenges. These hurdles included enrollment delays, operational management complexities, and an intricate study design.
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This randomized controlled pivotal phase 3 study evaluated efficacy and safety of neoadjuvant complex biologic, Leukocyte Interleukin Injection (LI), administered for 3 consecutive weeks pre-surgery, in treatment naïve resectable subjects with locally advanced primary SCCHN oral and soft palate squamous cell carcinoma. Access the publication.
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As cancer therapies grow more complex and personalized, patient-reported outcomes (PROs) have emerged as a vital component of oncology research and care. Beyond quality of life, PROs now encompass treatment adherence, care satisfaction, and symptom burden, with particular value in immunotherapy where novel toxicities demand real-time insight.
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Learn from the collaborative efforts between a biotech startup pioneering innovative gene therapies and Ergomed Consulting, in navigating the pre-IND phase for a novel gene therapy targeting a rare form of leukemia. The startup encountered significant challenges in aligning with FDA standards for product quality, safety, and efficacy, as well as in compiling a comprehensive Investigational New Drug (IND) application.
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