The role of pharmacovigilance is to determine which adverse events cross the line of a drug’s efficacy. Analysing which side effects are worth the risk to patients compared with how effective they are at treating a disease. To get approval to market and to continue to market drugs pharma companies have to follow PV guidelines set by International standards ( WHO through UMC Uppsala monitoring centre ) (ICH International conference of harmonization). Also they have to follow national guidelines like US FDA MHRA UK , DCGI India etc.
Team at Infocorp has a rich experience in pharmacovigilance IT domain. We can deliver value to yourself by providing custom low cost pharmacovigilance applications and services. We develop all Pharmacovigilance-related Standard Operating Procedures in compliance with global regulatory requirements safeguarding data integrity and keeping quality standards. Key Areas we work on: