Bnpedge

Strategic consulting, design and development using Cloud PaaS services. Our core portfolio includes Study Protocols, ICH GCP compliant clinical study reports (CSRs); Phases I to IV, Clinical trial.gov updates for public disclosure, Clinical sections of the Common Technical Document (CTD) including summaries and overviews, Investigator Brochures, Patient safety narratives, Pharmacovigilance documents such as Periodic Safety Update Reports (PSURs) and Development Safety Update Reports (DSURs), Standard Operating Procedures (SOPs) covering all aspects of drug development including the design, conduct and reporting of clinical trials, Initial Pediatric Study Plan (iPSP), Failure Mode Effects and Criticality Analysis (FMECA) and FMEA.