Patient safety in the innovative sphere of complex oncology requires an experienced safety operations team who are at the forefront of rapidly evolving clinical and regulatory challenges. Partnering with OncoBay Safety Operations offers comprehensive solutions in advancing your product through the development process.
Safety Management Plans – SMP creation and coordination, define study safety activities, roles and responsibilities and provide governance and oversight.
Clinical Safety – Dedicated safety team with experience in the collection and evaluation of serious Adverse Events in immuno-oncology studies.
Safety Database – eNNOV™ Safety Database, SAE processing, reporting and distribution, periodic safety update reports. Expertise in all major safety databases
Regulatory Reporting – Database to Database transmission electronic reporting to regulatory authorities which streamlines the reporting process and enables on-time reporting to regulators.
Global Safety Database Holder – House all your safety data in one database ensuring consistency of data and the ability to aggregate safety data quickly for ongoing risk-benefit evaluation. Avoid safety database migrations and loss of data integrity.