Clinical Trial Management

ReSQ Clinical Research has a strong reputation and extensive experience in the operational set up, management and close out of clinical trials in Australia and New Zealand for local and global sponsors through:

• Identification and selection of clinical trial sites

• Collection of essential documents

• Regulatory approval by TGA in Australia or Medsafe in New Zealand

• Ethics approval, including leverage and maintenance of multi-site approvals

• Research governance approval

• Review of investigational product labelling to ensure compliance with local regulatory requirements

• Investigator meetings

• Site initiation

• Site monitoring

• Safety reporting to regulatory authorities and ethics committees

• Close out