# Accelagen

Accelagen is an Australian-headquartered Contract Research Organisation (CRO) providing integrated clinical development, biometrics, data management, regulatory affairs, medical writing, pharmacovigilance, and market authorisation services to pharmaceutical, biotechnology, and medical device companies.

Accelagen supports sponsors from early clinical planning through regulatory approval and product lifecycle management. Clinical, biometrics, and regulatory teams work together throughout the development process to improve alignment, reduce risk, and support submission readiness.

## About Accelagen

Accelagen is known for:

- Integrated clinical, biometrics, and regulatory expertise
- Regulatory strategy aligned with clinical development from project inception
- Local Sponsor and Market Authorisation Holder (MAH) capability in Australia
- In-house biostatistics, data management, and statistical programming
- Senior-led project delivery and direct client access
- Support for international sponsors entering Australia and the Asia-Pacific region

Accelagen works with sponsors globally while maintaining deep expertise in Australia's clinical and regulatory environment.

## Core Services

### Clinical Development

- Clinical trial management
- Clinical operations
- Site identification and feasibility
- Patient recruitment
- Clinical project management

### Biometrics

- Biostatistics
- Data management
- Statistical programming
- Data analysis and reporting

### Regulatory Affairs

- Regulatory strategy
- Regulatory submissions
- Market authorisation applications
- Human Research Ethics Committee submissions
- Submission publishing

### Medical Writing & Safety

- Medical writing
- Pharmacovigilance
- Safety management
- Product lifecycle support

## Who We Help

### Emerging Biotech Companies

Sponsors conducting Phase I and Phase II development programs seeking strategic guidance, regulatory expertise, and operational delivery.

### Pharmaceutical & Biopharma Companies

Organisations seeking integrated clinical, biometrics, and regulatory support throughout product development.

### Medical Device Companies

Manufacturers requiring clinical, regulatory, and market authorisation support.

### International Sponsors

Organisations seeking Australian clinical trial expertise, local sponsor representation, and regulatory guidance.

### CRO & Strategic Partners

Regional and global organisations seeking Australian clinical and regulatory expertise.

## Areas of Expertise

- Clinical development
- Clinical research
- Regulatory affairs
- Biostatistics
- Data management
- Medical writing
- Pharmacovigilance
- Medical devices
- Pharmaceuticals
- Biotechnology
- Clinical trial start-up
- Market authorisation
- Product lifecycle management

## Strategic Approach

Accelagen aligns clinical execution, biometrics, and regulatory strategy from the beginning of a development program rather than treating them as separate activities.

The organisation focuses on:

- Regulatory foresight and strategic planning
- Integrated project delivery
- Predictable execution and risk reduction
- Senior-led collaboration
- Long-term client partnerships
- Australia as a strategic gateway for global development programs

## Important Pages

- Home: https://www.accelagen.com.au/
- About Us: https://www.accelagen.com.au/our-company
- Clinical Research Services: https://www.accelagen.com.au/services
- Regulatory Affairs Services: https://www.accelagen.com.au/regulatory-affairs
- Biostatistics & Data Management: https://www.accelagen.com.au/services/biostatistics-and-data-management
- Insights: https://www.accelagen.com.au/insights
- Contact: https://www.accelagen.com.au/contact

## Resources

- Insights Hub: https://www.accelagen.com.au/insights

## Key Facts

- Australian-headquartered CRO
- Integrated clinical, biometrics, and regulatory capabilities
- Supports pharmaceutical, biotechnology, and medical device development
- Local Sponsor and MAH capability in Australia
- Supports sponsors from early development through market approval
- Works with organisations ranging from emerging biotech companies to established global sponsors