---
name: Novotech
slug: novotech-cro
site: cro
website_domain: novotech-cro.com
summary: 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.
tagline: Full-service CRO with 4,450+ trials and 50+ countries of experience in early-phase and oncology development.
founded_year: 
employee_count_band: 
employee_count_label: 
parent_name: 
parent_slug: 
hq_country: AU
tier2_domain_verified: false
updated_at: 2026-06-17T07:01:35.186Z
services_count: 19
modalities_count: 5
indications_count: 3
locations_count: 2
review_signal_gate: closed
generated_by: BioBM Editorial AI
---

# Novotech

Full-service CRO with 4,450+ trials and 50+ countries of experience in early-phase and oncology development.

Listed on cro.directory.

## Summary

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.

## At a glance

- HQ country: AU

## 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

- Cell Therapy
- Gene Therapy
- Radiopharmaceutical
- Biologics (Monoclonal Antibodies)
- Biologics (Other)

## Indications

- Oncology
- Cardiovascular
- Immunology

## Locations

- Headquarters, Sydney, New South Wales, Australia
- Regional Office, Singapore, Singapore

## Long description

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.

_Profile last updated: 2026-06-17T07:01:35.186Z. Profile facts may include AI-assisted enrichment._

Auto-generated by BioBM Editorial AI for machine-readable profile access.