Adverse Events Reporting

Capture and Reporting of AEs : The configurable nature of our trial management software allows for incorporation of FDA required AE international terminology such as MedDRA (Medical Dictionary for Regulatory Activities). Individual safety reports can also be generated programmatically for reporting of adverse drug reaction (ADR) or adverse event (AE), reporting of ADRs and AEs in tables and line listings and reporting of ADR or AE patterns. AE or pharmacovigilance reporting of SAEs (serious adverse effects) or SUSARs (suspected unexpected serious adverse reactions) related to a therapy are coded and linked in our database to a patient or patient groups.

Pharmacovigilance (PV) Reporting Templates & Study support :  Pharmacovigilance related data collection and reporting is an important aspect of any health-care submission. In order to facilitate this, we have expertise in the creation of required periodic and non-periodic safety reports and associated documents for various regions. These include Bridging reports, EU CT Directive reports, EU Safety reports, Line Listings, Periodic Safety Update Reports (PSURs), Quarterly SUSAR and Safety reports, etc.  In addition, we work with global pharma clients to configure reports based on their local reporting needs and guidelines.