Pharmacovigilance

Pharmacovigilance

We specialise in adverse event reporting for prescription drugs, devices and consumer products. All types of cases are processed by our team. We work on client specific projects including large data migration projects. Our teamis committed to achieving your pharmacovigilancegoals and meeting your deadlines.

We can work with you to design pharmacovigilance services based on your requirements. We will work with your operational procedures and workflows to integrate into your environment flawlessly. Communication and accountability are key factors and we take them both seriously.

ADVERSE EVENT REPORTING:

Our expertise lies in processing all types of adverse event reports:

Clinical Trials
Post-Marketing
Literature
Special Scenario Cases

Our team takes care of end to end case processing services:

Triage
Data Entry
Quality Check
Medical Review
Final Review
Drafts
Submission
  • We can also step in at any stage as per client requirements in order to create a model designed to meet your needs.

Each team has members dedicated to literature case processing services:

Literature Search
Abstract Review
Article Review
Data Entry
Quality Check
Medical Review
Final Review
Drafts
Submission
  • In addition we support our clients with monthly literature reports.

We can work with you to design pharmacovigilance services based on your requirements. We will work with your operational procedures and workflows to integrate into your environment flawlessly.

Our team is proficient with Argus and we also have certified MedDRA coders in our team.

AGGREGATE REPORTING:

Our regulatory experts will work with you throughout the product lifecycle.

We can work on a report in full entirety or a specific section. The following are the reports that we can work on as a comprehensive solution to your aggregate reporting needs.

  • Periodic benefit/risk evaluation reports (PBRERs)
  • Periodic safety update reports (PSURs)
  • Developmental safety update reports (DSURs)
  • Periodic adverse drug experience reports (PADERs)
  • Support for risk management plans (RMPs) and risk evaluation and mitigation strategy (REMS)