Targeted CRO Clinical Trial Services for Oncology, HIV & Neurodegeneration
Cytonova Labs provides full-spectrum CRO support across Phase I–IV clinical trials in solid tumors, hematologic malignancies, HIV, and Alzheimer’s disease. Our teams integrate protocol and synopsis development, adaptive and basket trial designs, biomarker-driven patient stratification, and centralized risk-based monitoring to compress timelines while preserving data integrity. As an oncology-, virology-, and neurodegeneration-focused CRO, we align every program with ICH-GCP, CDISC (SDTM/ADaM), and global regulatory expectations from first-in-human through post-marketing commitments. We operate on validated EDC platforms with CDISC-compliant SDTM/ADaM datasets, ICH-GCP–aligned SOPs, and global site networks across North America, Europe, and Asia-Pacific. From feasibility and site start-up through database lock, submission-ready outputs, and long-term safety follow-up, we deliver audit-ready documentation and transparent, real-time analytics for sponsors and regulators.
Phase I
Oncology & HIV focus: Evaluating safety, tolerability, and dose-escalation in first-in-human studies.
Phase II
Proof-of-concept & dose-finding. Establishing efficacy endpoints in Alzheimer’s and neuro studies.
Phase III
Pivotal efficacy & safety. Large-scale global site networks for hematologic malignancy filings.
Phase IV
Long-term safety & real-world evidence. Pharmacovigilance across the entire drug lifecycle.
Clinical Trial Management
Accelerating oncology, HIV, and Alzheimer’s programs through detailed protocol and synopsis development. Our teams execute Phase I–IV operations with precision in feasibility, site selection, and randomization strategies.
Site Monitoring
Ensuring data integrity through rigorous Risk-Based Monitoring (RBM). Our CRAs focus on ICH-GCP compliance, utilizing remote monitoring tools to detect risks early in HIV and neuroscience studies.
Data Management & Biostatistics
Leveraging high-end Electronic Data Capture (EDC) and CDASH/SDTM standards. We provide advanced statistical modeling via ADaM dataset generation to distill critical neurological clinical insights.
Regulatory Submissions
Expert strategic guidance through FDA and EMA pathways. We manage complex IND/NDA filings, CMC documentation, and Orphan Drug Designations for first-in-class therapies globally.
Pharmacovigilance & Drug Safety
Continuous safety signal detection and integrated SAE/E2B reporting. We protect participants through robust medical monitoring and real-time safety database management throughout the drug lifecycle.