Pre-Preparation and Submission of Aggregate Reports

Development and maintenance of an aggregate reporting schedule
Planning of a preparation and review schedule with agreed timelines for all parties involved in the preparation and review, including requesting and collating information
Generation of listings from the safety database
Preparation of line-listings and tabulations for inclusion in the report
Drafting, medical review, formatting of reports
Submission of reports, including registration and submission of reports via centralised repositories for aggregate reports if required, including submission via PSUR centralised repository, Common European Submission Portal (CESP) and other portals for electronic submission
Submission of reports by courier service in either paper or CD format
Provision of quality metrics
Management of assessment reports and responding to any questions that may arise from authorities