The accurate and timely processing and reporting of serious adverse events is a crucial element of a successful clinical trial. Sponsors must ensure that proper processes and procedures are set-up to protect clinical trial subjects/patients as well as assure timely safety reporting to research sites, ethics committees and competent regulatory authorities.
At insuvia, we work closely with clinical trial Sponsors, CROs and sites to monitor the clinical safety of investigational products and detect any change to their risk-benefit profile, and to ultimately assure compliance against all relevant reporting requirements.
Our clinical safety processes have been specifically designed to meet the needs of smaller Sponsors and to provide them with a flexible and cost-effective full-service safety department as an outsourced solution. Alongside the central clinical safety service, we utilize our local pharmacovigilance network to support Sponsors and CROs with country-level submissions of expedited and periodic reports as well as to fulfil applicable local cross-reporting requirements.