Oncology CRO
The majority of Ockham’s clinical trials have focused on the therapeutic area of oncology.
Ockham as an Oncology CRO, provides experts that possess the skills needed to support all stages of clinical development:
- Study design with team of medical, statistical, and regulatory expert
- Full clinical development plans
- Protocol development and preparation
- Feasibility studies
- Site-selection strategies
- Full Contract Research Organization (CRO) services for execution of the study.
In addition, Ockham also provides a full set of Regulatory Services, including:
- IND Gap Analysis
- IND Development
- CMC/Pharm Tox
- IND Assembly and Submission
- Pre-Clinical Development
- FDA Interactions and Negotiations
- Pre-IND Planning
- NDA/BLA Development and Submission
Ockham has experience with a wide range of cancer types, including:
Solid Tumors
- Ovarian
- Breast
- Lung
- Colorectal
- Pancreatic
- Bladder
- Head and Neck
- Cervix
- Renal Cell
- Prostate
- Melanoma
- Skin
- Hepatoma
- Kaposi’s Sarcoma
Hematologic Malignancies
- Acute myelogenous leukemia
- Chronic myelogenous leukemia
- Non-Hodgkin’s lymphoma
- Myeloma
- Acute promyelocytic leukemia
- Essential thrombocytosis
Experience with Multiple Drug Classes
- Antiangiogenic agents
- Autologous/allogeneic BMT
- Biological response modifiers
- Colony stimulating therapy
- Cytokine inducers
- Cytotoxics – systemic and topical
- Epidermal growth factors
- Gene therapy
- Hormonal therapy
- MDR reversing agent
- Monoclonal antibodies
- Targeted radiotherapy