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Australian Local Sponsor and CRO Oversight

Australian Local Sponsor Services

Sunrise Clinical provides trusted local sponsor services for international biopharma, medtech, and CRO partners conducting clinical trials in Australia. As a registered Australian entity, we ensure full compliance with TGA regulations, HREC requirements, and CTN/CTX frameworks.

Scope of Work

  • Act as your Australian legal sponsor

  • Manage CTN/CTX submissions and ethics approvals

  • Oversee safety reporting and pharmacovigilance

  • Ensure insurance, indemnity, and site governance

  • Boutique, people-first approach with agile support

CRO Oversight Services

Sunrise Clinical partners with sponsors to ensure their CROs deliver to the highest standards of quality, compliance, and performance. We support sponsors to fulfil their regulatory accountability through proactive governance, risk-based oversight of CRO performance, and clear, actionable insights.

Scope of Work

  • Oversight framework & governance

  • CRO selection & due diligence

  • Contract & KPI development

  • Ongoing CRO performance oversight

  • Risk-based oversight & issue management

  • Governance meetings & reporting

  • Sponsor representation