PSURs, ASRs and Periodic Reports
PharSafer® have written many PSURs for Companies and on average over the last few years have written well over 100 PSURs per year. All PSURs are written to either the Company template (or the PharSafer® template) and include medical review (if required) and we have also written Addendum Reports, Summary Bridging Reports, Clinical Expert Reports and Pre-Clinical Expert Reports for client Companies.
For many Companies PharSafer® also supply PSUR schedules and compliance assessments and also help in harmonising PSURs to common birth dates to streamline the submissions to Regulatory Authorities. Additionally, and as a requirement for PSURs, PharSafer® has also written Company Core Safety Information (CCSI) to accompany the PSURs as well.
All PSURs undergo multiple reviews and a formalized quality check before client release and comply with both ICH and National submission requirements globally.
PharSafer® also submit the PSURs to the Regulatory bodies and provide compliance statistics as well as the assessment reports for client review.
Periodic Reports
PharSafer® also produce periodic reports (USA periodic reports) for clients in the USA where waivers for PSURs have not been granted. PharSafer® has SOPs and templates for the production of US periodic reports to the FDA.
Clinical Periodic Reports (IND Annual Reports and Annual Safety Reports)
Clinical Annual Safety Reports (ASRs) according to European legislation and templates have been produced and submitted by PharSafer® to the various Regulatory Authorities; Ethics Committees and form part of the Trial Master File for any GCP Inspections.
All data for the ASR is derived from the PharSafer® validated safety database in the formats required.
PharSafer® has also submitted on behalf of clients Investigational New Drug (IND) annual reports to the FDA according to FDA regulation too.
PharSafer has also been involved in the production of Developmental Safety Update Reports (DSURs) for clients as part of internal safety reviews and to provide documents that mirror the post-marketing PSURs.
In addition, PharSafer® also produce and submit the EU legislated quarterly/6-monthly reports to EU Ethics Committees and ad hoc reports used in Safety Review Meetings.
PharSafer® has also produced reports for submission to Independent Data Monitoring Committees (DSMBs; IDMCs) for safety reviews and designed DSMB charters for Client Companies.