Embark on groundbreaking clinical research with confidence, supported by Pulse Clinical's leading IRB/IEC & Regulatory Submissions Services. Our team, seasoned in the intricacies of clinical trial ethics, governance, and regulatory services,, navigates this complex landscape to ensure your studies uphold the highest ethical standards and comply with both regional and international regulations.

Our Approach

Unmatched Expertise

Benefit from our seasoned professionals' in-depth knowledge of the regulatory frameworks in Australia and New Zealand. We guide you seamlessly through approval processes, ensuring compliance.

Tailored Solutions

Recognizing the uniqueness of each clinical trial, we offer custom solutions aligned with the highest ethical standards. From drafting Human Research Ethics Applications (HREAs) to electronic Clinical Trial Notifications (eCTN) submissions to TGA, we expedite the approval process.

We elevate your clinical research endeavours with our leading IRB/IEC & Regulatory Submissions Services, ensuring ethical compliance and seamless approval processes in Australia and New Zealand.

Key Services

Ethics Committee Submissions

Navigate ethics committee approvals with precision. We manage the entire process, as follows:

• Complete your Human Research Ethics Application (HREA), as well as any ancillary documents such as the Victorian & Western Australia Specific Modules (VSM & WASM, if applicable) and upload to ERM, REGIS or RGS (as applicable).
• Draft templates for Standard & HREC Only Indemnities and organise their execution via electronic signature workflows.
• Liaise with your Sponsor for other key application documents such as patient questionnaires or study insurance certificates.

Governance Oversight

Efficient governance is crucial. We complete your site-specific authorisation (SSA) application, draft your informed consent documents, and any other study document as required.

Trust Pulse Clinical to guide your clinical trials through the intricate landscape of ethics and governance, incorporating TGA and eCTN expertise. Focus on advancing medical breakthroughs while we handle the complexities of regulatory compliance. Contact us today to discuss how our IRB/IEC & Regulatory Submissions Services can elevate your clinical research endeavours.