Expertise in Oncology Drug Development
From our advisory board to our project managers and our CRAs, Medelis offers deep experience in every facet of the oncology drug development process at all levels of our organization. Our clinical team members and medical personnel have critical first-hand experience in the complex issues often associated with oncology studies, which means that highly experienced resources will be working on your trial. And whether it’s a standard dose-escalation phase I trial or a complex rescue of a phase III trial, chances are that our team has handled it before.
Medelis' expertise begins with the thought leadership of our world-class Medical Expert Team, a group that delivers a wealth of experience in the design, performance and analysis of oncology clinical trials. These experts are actively involved with our study team, providing immeasurable expertise with study design, site selection, patient populations, and the latest trends and ideas in oncology drug development from around the world.
Together, our board offers
- A combined 143 years of experience in oncology drug development
- 422 INDs filed
- 76 NDAs filed
Our expertise continues with our project managers, all of whom have
- A minimum of 8 years of clinical research experience
- Phase I/II/III project management experience
And our CRAs on the front lines all have
- A minimum of 4 years of oncology monitoring experience
- Phase I/II/III study monitoring experience
- EDC experience
- Excellent relationship skills
This therapeutic depth and experience translates into into faster start-up, better problem identification and resolution, more informed decision-making and a corresponding increase in the quality of your results while, at the same time, reducing risk.
Indications, sponsor types and geographic experience
- Our team has managed phase I through phase IIIs in the US, Canada and Europe.
- We offer extensive EDC experience including usage in those phase I trials that need to carefully balance costs and reporting speed.
- We've worked with all different sponsor types: public and private, biotech and pharmaceutical, governmental, large and small, European and U.S.
- Our medical monitors are always board-certified oncologists.
- We’ve handled most targets within oncology:
- Acute myeloid leukemia (AML)
- Bone marrow transplant
- Breast
- Cervical
- Chronic lymphocytic leukemia (CLL)
- Chronic myelogenous (or myeloid) leukemia (CML)
- Colorectal
- Endometrial
- Gastrointestinal stromal tumor (GIST)
- Genitourinary indications
- Gliomas
- Head and neck
- Hepatocellular carcinoma
- Idiopathic thrombocytopenic purpura (ITP)
- Lymphoma
- Malignant ascites
- Melanoma
- Multiple myeloma
- Neuroendocrine tumors
- NSCLC
- Oral mucositis
- Ovarian
- Pancreatic
- Pediatrics
- Prostate
- Renal cell carcinoma
- Sarcoma
- Solid tumors
- Thoracic indications
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In addition, our relationships within the oncology community allow us to bring aboard additional experienced resources if we run across that rare instance requiring a unique expertise.
Please contact us now for more specific details about our experience and how we can assist with your clinical development plan.
