Adverse clinical trials not only affect the participants but will have a serious impact on valuation of the biotech company and its ability to raise capital for future R&D.
Proposals for clinical trials of medicines and medical devices, whether conducted in Australia or overseas, require careful planning, scrutiny and independent expert and legal review to minimise the risk of serious adverse reaction or informed consents being invalidated.
Reporting of test results must be accurate so that existing and potential investors are not mislead as to the potential for regulatory approval and commercialisation. Independent review and audit of clinical trial processes and results can be used to limit the company’s and its directors’ exposure to legal claims.
Stephens Lawyers & Consultants also advises on all aspects compliance and risk management including privacy, data and health records protection laws.