Vigilex staff are experts in writing periodic reports such as Periodic Safety Update Reports (PSURs), Periodic Benefit Risk Evaluation Reports (PBRERs), Development Safety Update Reports (DSURs) and signal evaluation reports. Medical review of the relevant sections can either be performed by the client or by medical staff of Vigilex. In addition Vigilex provides support in the composition and review of Risk Management Plans (RMPs). Vigilex staff also reviews periodic reports written by clients on their request to ensure consistency and compliance with applicable regulations and guidelines.
Periodic reports can be written in accordance with the client's own template or the Vigilex template.