A US-based biopharmaceutical firm has approached SeerPharma to perform audits of their critical service providers. The company is about to undertake a phase I clinical trial in Australia of one of its therapeutic molecules.
The firm utilises a variety of Australian facilities to perform clinical trials; manufacturing and formulation of their investigational product; and the final filling of product. As part of its regulatory obligations as the sponsor of the trial, the company must ensure compliance with Australian and US regulatory requirements, along with all relevant international codes of practice.
SeerPharma has been requested to perform:
- Clinical Research Organisation (CRO) audit
- Manufacturer audit
- Finish and Fill Facility audit
- Clinical Site audit
- Clinical Trial Sample Storage and Distribution Provider audit
- BioAnalytical Testing Site audit
Contact us if you’d like more information on our expertise with auditing facilities that have an impact on your product quality.
This post comes from our April 2015 Journal.
