Sticares InterACT provides a broad range of services in the field of Pharmacovigilance that can assist you during the whole life-cycle of your medical product. Our biggest potential lies in our people who are well trained and prepared to meet all the requirements and standards in drug safety. They are always on top of the latest concerning legislation and good PV practice.

Our special focus is on clinical studies before as well as after marketing authorization. In cooperation with our medical writers we can create and/or review safety concerns during the preparation of the study (safety part of the protocol, SAE form); during the study our tasks include the collection, assessment and reporting of all the safety issues to the competent authorities. With the help of our medical writers we can prepare periodic and/or final reports about the safety profile of the study.

Sticares InterACT supports worldwide submission in accordance with all national and international requirements using the ICH E2B format, including submissions to the EMEA EudraVigilance database.