Oncology Focused Clinical Research
Comprehensive oncology clinical trial support spanning solid tumors and hematologic malignancies — from early-phase immuno-oncology to large-scale Phase III registrational trials and post-market surveillance.
Integrated Oncology Research Expertise
Oncology remains one of the most active and rapidly evolving areas of clinical research, with immunotherapies, targeted therapies, antibody-drug conjugates (ADCs), and cell therapies reshaping the treatment landscape. Omega CRO provides comprehensive support across the full spectrum of oncology drug development, from first-in-human dose-finding studies to pivotal Phase III trials and real-world evidence generation.
Our integrated approach combines therapeutically-aligned medical leadership, specialized operational teams, advanced biomarker strategies, and centralized laboratory services through the Omega ecosystem. We understand the unique complexities of oncology trials — adaptive trial designs, complex eligibility criteria, companion diagnostics, immune-related adverse event management, and the growing importance of molecular profiling in patient stratification.
Solid Tumors & Hematologic Malignancies
Our experience spans the most prevalent and scientifically challenging oncology indications.
Solid Tumors
- Non-Small Cell Lung Cancer (NSCLC)
- Breast Cancer (HR+, HER2+, TNBC)
- Colorectal Cancer
- Hepatocellular Carcinoma (HCC)
- Melanoma & Immunotherapy Studies
- Prostate & GU Cancers
Hematologic Malignancies
- Acute Myeloid Leukemia (AML)
- Acute Lymphoblastic Leukemia (ALL)
- Multiple Myeloma
- Chronic Lymphocytic Leukemia (CLL)
- Non-Hodgkin & Hodgkin Lymphoma
- Myelodysplastic Syndromes (MDS)
Emerging Modalities
- Immuno-Oncology (Checkpoint Inhibitors)
- Antibody-Drug Conjugates (ADCs)
- CAR-T & Cell Therapies
- Targeted Therapies & Tyrosine Kinase Inhibitors
- Bispecific Antibodies
- Gene Therapy & Oncolytic Viruses
Biomarker Strategy & Companion Diagnostics
Modern oncology trials demand sophisticated biomarker strategies for patient stratification, response monitoring, and safety surveillance.
Molecular Profiling
PD-L1, MSI/MMR, TMB, EGFR, BRAF, KRAS, ALK, ROS1 testing for patient selection.
Liquid Biopsy & ctDNA
Circulating tumor DNA monitoring for minimal residual disease (MRD) and treatment response.
Central Imaging
RECIST 1.1, iRECIST, and mRECIST central radiology review for standardized endpoint assessment.
Immunogenicity
Anti-drug antibody (ADA) and neutralizing antibody (NAb) assays for biologics and cell therapies.
Oncology Trial Capabilities
Adaptive Trial Design
Bayesian and frequentist adaptive designs, basket/umbrella trials, and seamless Phase II/III designs for efficient oncology drug development.
Risk-Based Monitoring
Centralized and risk-based monitoring strategies tailored to complex oncology protocols with high safety monitoring needs.
Safety & Pharmacovigilance
Dedicated oncology safety monitoring including irAE management for immuno-oncology trials and SAE reporting.
Regulatory Strategy
Comprehensive regulatory submissions including IND/CTA, orphan drug designation, and scientific advice preparation (FDA, EMA, TİTCK).
Application Scenarios in the Omega Ecosystem
How the Omega ecosystem powers precision oncology trials\u2014from molecular profiling to centralized imaging, immunogenicity, and biobanking.
HelixLab
Safety Labs & Tumor Markers
Comprehensive oncology safety panels (CBC with differential, comprehensive metabolic panel, coagulation), serum tumor markers (CEA, CA 19-9, CA 125, PSA, AFP), and LDH for response monitoring.
Omega Genetics
Molecular Profiling & MRD
Tissue NGS panels (EGFR, KRAS, BRAF, ALK, ROS1, RET, NTRK), MSI/MMR testing, TMB calculation, and liquid biopsy ctDNA monitoring for minimal residual disease (MRD) and treatment response.
Omega Biorepository
FFPE & Frozen Tissue Archive
Tumor tissue biobanking (FFPE blocks and flash-frozen OCT) with complete chain-of-custody for retrospective biomarker analysis, companion diagnostic validation, and translational research.
Omega Care
Remote PRO & AE Monitoring
Home-based patient-reported outcome capture for irAE symptom tracking; remote symptom diaries and telemedicine integration reducing visit burden for immuno-oncology patients.
Omega Bio
PD-L1 & Companion Dx Kits
Kit-based standardization for PD-L1 IHC (22C3, 28-8, SP142, SP263) assays ensuring cross-site scoring harmonization; companion diagnostic kit validation and deployment.
Animal Facility
PDX & Syngeneic Tumor Models
Patient-derived xenograft (PDX) models, syngeneic models for immuno-oncology combination studies, and CDX models for preclinical efficacy of targeted therapies and ADCs.
Accelerate Your Oncology Development Program
Partner with Omega CRO for integrated oncology clinical research expertise from early phase to post-market.
Talk to Our Experts