ARGCIC - PHARMACO-VIGILANCE APPLICATION

Patients' safety is given prime importance for ongoing medical support at the site. Serious Adverse Events and Adverse Drug Reactions are all monitored, documented and reported within the defined timelines. Our team consists of several Physicians and Doctorates in Pharmacology with experience in Pharmacovigilance practices for trials across a wide array of therapeutic indications.

  • Providing medical monitoring/support to sites

  • Serious Adverse Event (SAE) Management

  • Assessment of Causality and Expectedness of Adverse and Serious Adverse Events

  • Preparation of Alert letters

  • Medical Writing Authoring of clinical study documents (Protocol, Investigators Brochure, Summary reports and Publications and authoring of medical communications

  • Our team consists of several Physicians and Doctorates in Pharmacology with experience in medical writing for trials across a wide array of therapeutic indications

Argus Safety consulting and Implementation services

  • Implementation and customizations

  • Validation

  • Data Migration

  • Upgrade

  • Hosting / Cloud computing

  • Maintenance and Support

  • Oracle Partnership and Oracle Certified/Specialized team

  • ICSR Processing

  • Training