Medelis
Medelis is a full-service oncology CRO specializing in phase I through phase III oncology trials, with extensive experience in immuno-oncology therapies since 2008.
Services Provided by Medelis
Medelis is a full-service oncology CRO offering a broad range of services essential to the successful execution of clinical trials. These services include study design, study launch, study management, medical writing, biostatistics and data management, study rescue, drug development consulting, and access to the U.S. market. The company also specializes in oncology drug development consulting services, such as adaptive design alternatives, regulatory approval consulting, and bioequivalence study design for generic oncology drugs.
Oncology Trial Expertise
Medelis has extensive experience managing complex oncology clinical trials, including those involving immunotherapy and precision oncology medicine. Since 2008, Medelis has been actively developing immuno-oncology therapies and has managed over 200 oncology studies. This experience includes a specialization in CAR T-cell therapy studies and checkpoint inhibitor studies. Medelis has developed site SOPs for immunotherapy, ensuring standardized procedures and patient safety.
Immuno-Oncology Development Since 2008
Medelis has been at the forefront of immuno-oncology development since 2008. The company has pioneered immunotherapy treatments and has established comprehensive site SOPs specific to immunotherapy. Their deep experience spans across diverse immunotherapy targets, contributing to the advancement of oncology treatments. Medelis’s involvement in CAR T-cell therapy studies and checkpoint inhibitor studies highlights their significant role in the field.
Global Reach and Partnerships
Medelis operates on a global scale, managing clinical trials across three continents. Through a partnership model, Medelis conducts trials in nearly any country, providing flexibility and access to optimal sites and patient populations. Medelis’s strong network of investigator relationships enables quick study launches and effective patient recruitment. This global approach is reinforced by their capability to offer access to the U.S. market for non-U.S.-based companies.
Track Record and Project Management
Medelis has a remarkable track record in clinical trial management, with 96% of projects completed on budget and 91% on time. The company assigns a dedicated project manager to each trial for consistent oversight and management throughout the study. With a history of successfully rescuing troubled studies, Medelis can reverse issues and regain lost time with minimal additional expense to clients. Their approach to study rescue involves reviewing all study elements, identifying key issues, and developing a comprehensive rescue plan.