ICON’s Aggregate Reporting services are focused on quality and compliance. With extensive experience providing stand-alone aggregate report production services, we have successfully written, published or submitted more than 700 documents in recent years. The collaboration of ICON´s writing, pharmacovigilance, regulatory and publishing services ensures the development of submission-ready documents: final, approved safety reports are published in an eCTD and NeeS format and submitted to the appropriate regulatory agencies by the specified pathways.
Our aggregate reporting service is founded on:
- Strong expertise and experience in writing and publishing periodic safety reports
- Independent medical review and input to ensure high medical quality
- Maximum flexibility in timelines and resources, within the framework of quality standards and regulatory compliance