Novotech
Full-service CRO with 4,450+ trials and 50+ countries of experience in early-phase and oncology development.
Listed on cro.directory
Global full-service CRO specializing in early-phase and oncology trials across 50+ countries, with expertise in cardiovascular, cell and gene therapy, and radiopharmaceutical development. Headquartered in Sydney, Australia.
Phases
Indications / Therapeutic Areas
Services
- Phase I Clinical Trials
- Phase II Clinical Trials
- Phase III Clinical Trials
- Phase IV / Post-Marketing
- Clinical Operations
- Oncology Specialty Services
- Cardiovascular & Metabolic Specialty Services
- Immunology & Inflammation Services
- Regulatory Affairs
- US FDA Regulatory Strategy
- EU EMA Regulatory Strategy
- China NMPA Regulatory Strategy
- Japan PMDA Regulatory Strategy
- Medical Writing
- Pharmacovigilance & Drug Safety
- Biostatistics & Statistical Programming
- Data Management & eClinical
- Central Laboratory Services
- Bioanalysis
Modalities
Technical specifications & accreditations
Infrastructure
About this organization
Novotech is a globally recognized full-service clinical research organization (CRO) and scientific advisory partner for biotech and small to mid-sized pharma companies. The organization has executed 4,450+ trials across 7,260+ trial sites with 4,950+ investigators in 50+ countries, supporting 60+ drugs to market.
Core Service Capabilities:
- Early-phase trial expertise, including Phase I/II dose-escalation and dose-expansion studies
- Oncology-focused clinical development with specialized early-phase oncology strategy and execution support
- Cell and gene therapy trial management
- Radiopharmaceutical development and clinical translation
- Medical and regulatory consulting (pre-clinical, regulatory affairs, pharmacovigilance)
- Patient recruitment and site selection leveraging in-country knowledge and real-world data
- Clinical operations and project management with integrated, streamlined delivery
- Site Management Organization (SMO) services through Acrostar division
- Biostatistics, data management, and biometrics services
- Bioanalytical laboratory services supporting molecule development stages
- Real-world data (RWD) acceleration for patient recruitment and drug development
Therapeutic Focus Areas: Oncology, hematology, immunology, liver disease, and emerging modalities including cell and gene therapies. Australia-based early-phase trial capabilities with streamlined regulatory pathways.
Locations
Headquarters
Sydney · New South Wales · Australia
Regional Office
Singapore · Singapore
Submit a verified review for this organization.
Markdown mirror: /companies/novotech-cro.md