PBRERs, PSURs, DSURs and other Regional Periodic Reports

PharSafer® also produces periodic reports for clients in the USA where waivers for PSURs have not been granted. PharSafer® has SOPs and templates in place for the production of US periodic reports to the FDA as well as a variety of other country specific periodic reports.

Clinical Periodic Reports – IND Annual Reports and Developmental Safety Update Reports (DSURs)

PharSafer® provides Clinical Annual Safety Reports (ASRs), Developmental Safety Update Reports (DSURs) and USA IND annual safety submissions, all in line with European and international legislation (ICHE2F). We have produced templates and submitted them to the various Regulatory Authorities and Ethics Committees and they form part of the Trial Master File for any GCP Inspections.

All data for the ASR/DSUR is derived from the PharSafer® validated safety database in the formats required.

PharSafer® has also submitted Investigational New Drug (IND) annual reports to the FDA, in accordance with FDA regulation, on behalf of clients.

PharSafer® has 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/PBRERs.

In addition, PharSafer® also produces and submits the EU six-monthly reports to EU Ethics Committees and ad hoc reports used in Safety Review Meetings.

PharSafer® has produced reports for submission to Independent Data Monitoring Committees (DSMBs and IDMCs) for safety reviews and designed DSMB charters for Client Companies.