We have a unique CRO profile providing unique and innovative dual expertise combining clinical research implementation with the development of customized IT applications specific to the pharmaceutical industry.
Safety & Vigilance
Managing Safety: Materiovigilance & Pharmacovigilance
Your pharmaceutical or medical device company must move to a more efficient, strategically focused safety capability in order to be less reactionary, resource-intensive, and transaction focused, and become instead a more proactive agent for patient safety. This service is made for you.
In some companies, adverse events are often too rare to justify the full time presence of a Safety Manager. Safety matters are then delegated to a physician or pharmacist, in addition to his/her usual activities. He/she may then sometimes be unable to respect safety deadlines.
In addition, when the safety department has only one qualified person, his absence, for whatever reason, deprives the company of all official skills regarding safety.
PopsiCube-FOVEA has set up a complete safety environment to satisfy its own needs as well as its clients’ ones.
Our Core activities include:
- Collecting adverse drug reaction (ADR) data and information
- Case processing activities
- Preparing and development of Risk Management Plans (RMPs) and Risk Evaluation Mitigation Strategy (REMS)
- Creating and submitting expedited and aggregate PV reports
Our services include:
- Fix safety actions to be set up
- Provide a fully experienced physician in terms of regulatory matters
- Draw up safety management processes
- Report and follow-up all SAE 24/24, 7/7
- Check whether a SAE has to be reported, and to which authority
- Validate the elements required for proper reporting
- Report to French, European or American regulatory authorities
- Write Safety Reports
- Evaluate a continuous benefits/costs ratio
- Participate in the constitution of the Safety reporting committee and define its rules
- Set up the risks management plan
