Our Services
How can we help you?
Clinical Trials
We provide comprehensive support and guidance throughout the entire lifecycle of a clinical trial, from start-up and monitoring to close-out, across all phases (Phase 0 to post-market). Our services ensure compliance with local and international regulatory requirements, including ICH-GCP, TGA, FDA, and EMA standards. We help you achieve your goals, whether it's applying for funding, raising capital, or publishing results. Our services include:
- Regulatory Submission: IND (FDA), CTN/CTA (TGA)
- Clinical Trial Registration: ANZCTR, clinicaltrials.gov, and other international registries
- Quality Assurance: SOPs, documentation, and record keeping
- Budgeting and Financial Management
- Safety Monitoring and Risk Management
- Clinical Trial Research Agreements (CTRAs)
- Data Analysis and Report Writing
- Continuous Improvement
Human Ethics
We offer comprehensive Human Ethics Research preparation and submission services, ensuring your clinical trials are ready and fully compliant with all applicable ethical and regulatory guidelines. Our services include:
- Initial Submission Applications
- Study Protocol Development and Amendments
- Preparation and Amendment of Investigator Brochure Documents
- Participant Information Sheets and Informed Consent Forms
- Ongoing Support for Variations and Amendments
- Additional Services Upon Request
Researh & Development (R&D)
We offer expert guidance in preclinical studies to ensure a seamless transition to first-in-human trials. Our services include:
- Safety and Toxicology Studies
- Good Laboratory Practice (GLP)
- Accurate Record Keeping
- Standard Operating Procedures (SOPs)
- Project Management
Other Services
- Medical Writing
- Grant preparation support- Grant application preparation
- Business Development
- Vietnames Translation
- Additional Services Upon Request