Abstract
Every day Pharmaceutical and Biotechnology companies face safety reporting challenges as new regulations gain momentum. Current case study is about achieving a Regulatory milestone (E2B (R2) compliant format) crucial for pharmacovigilance submissions to Regulatory Agencies.
Client Introduction
The client is a well-known Clinical Research Organization having global presence of 14+ years in carrying out early phase trials, bioequivalence and bioanalytical studies and pharmacovigilance. Client has remarkable presence in the clinical research industry.
Need for Regulatory compliance
The client wanted to match the constantly growing Regulatory expectations. They needed system-automated XML formats for import of a safety report from Regulatory authority as well as export of Individual case safety reports (ICSRs) electronically to EMA/FDA and other regulatory authorities, accepting safety data only in structured XML formats.
Troubleshooting
PvNET, Sarjen’s comprehensive Adverse Event reporting solution, very well catered to this Regulatory requirement of import and export of safety data in XML formats, precisely complying to the guidance on technical specifications for data elements.
The format was compatible for database to database transmission thus ensuring there were no failures encountered while transferring the files.
Client Process Improvement
System-generated XML formats ensured that the safety data could be transmitted to Regulatory authority in their accepted format (ICH E2B and 21CFR Part 11 compliant).
The bonus point was auto-population of safety data from imported XML files in the respective data fields leaving the advance data entry personnel to only review the data entered. This minimized the possibility of trivial data entry errors while performing basic data entry.