Drug development in oncology has undergone profound changes. The emergence of highly active targeted therapies for subsets of patients with advanced, refractory cancers has led to the development of drugs better tailored to each individual patient.
These new drugs are being approved at a brisk pace by regulatory authorities, which have loosened their stance on efficacy endpoints, considering outcomes such as overall response rather than standard survival and have approved new treatments based on data from single-arm cohorts of Phase 1 or Phase 2 trials instead of from standard Phase 3 randomized trials. Consequently, Sponsors need to produce enough evidence to meet regulatory requirements faster than ever.
OPIS is an oncology-focused CRO with the insight and experience necessary to guide our partners through the ever-changing challenges of bringing new cancer therapies to market.
More than 300 studies managed
Indications: Advanced and metastatic breast cancer, advanced and metastatic melanoma, advanced solid tumors, head and neck squamous cell cancer, pancreatic neuroendocrine tumors, renal cell cancer, ALK positive malignancies, ALK-positive non-small cell lung cancer, bladder cancer, bone or soft tissue sarcoma, cancer pain, cerebral metastases in breast cancer, CD20+ tumor-infiltrating lymphocytes in cancer, cervical cancer, desmoplastic small round cell tumor, chordoma, colorectal cancer, cholangiocarcinoma, epithelial ovarian and primary peritoneal cancer, EGFR mutated non-small cell lung cancer, gastrointestinal stromal tumors, gastric cancer, glioblastoma, glioma, lung cancer, lung and thymus cancer, hepatocellular carcinoma, medulloblastoma, metastatic basal cell carcinoma, metastatic colorectal cancer, metastatic gastroesophageal cancer, metastatic endometrial cancer, metastatic head and neck squamous cell cancer, metastatic urothelial bladder, metastatic spinal tumors, non-small cell lung cancer, neuroendocrine tumors, pancreatic neuroendocrine tumors, prostate cancer, wild type advanced urothelial carcinoma, soft tissue sarcoma, subependymal giant cell astrocytoma associated with tuberous sclerosis complex
Phases: I, Ib, II, IIa, IIb, III, IIIb, IV
Other details: interventional and non-interventional studies, studies on medical devices, studies in adults and children