PROVENANCE PHARMACOVIGILANCE SERVICES

"A vigilant today for a safe tomorrow"

Provenance Pharmacovigilance team is composed of qualified healthcare professionals with wide clinical experience along with domain experience in pharmacovigilance and clinical research industry. We have a dedicated team of trained pharmacovigilance associates, scientists, and physicians who are experts in recognizing, processing, analyzing and reporting adverse events. We provide high quality safety surveillance services during all phases of clinical development and post-marketing to pharmaceutical, biotechnology and medical device companies. We also cater to companies that require our services to meet their productivity due to variable demand and high volumes.

Our services:

Case creation and Triage

• 24/7 call center support for collecting adverse event reports from clinical trials and post-marketing sources.
• Triage of cases based on seriousness and expectedness.

Case processing

• Entry and logging of adverse event data.
• Active query and follow-up of cases.
• MedDRA coding.
• Safety narrative writing and quality check of case reports for data completeness.

Medical Review

• Qualified physician review of the cases for completeness, accurateness, and capture of all medical concepts.
• Medical assessment/Causality assessment.
• Signal detection.

Submissions

• Adverse events tracking and routing.
• Expedited reports submission to regulatory authorities.
• Regulatory reporting to authorities, investigators, and ethics committees

Periodic Reports

• Annual safety reports.
• Periodic safety update reports.
• Bridging reports.
• Addendum reports.
• US Periodic reports.

Literature search

• Running searches for literature on client's products from online bibliographic databases.
• Entry of identified cases into the safety database.
• Literature searches for inclusion in PSURs, identifying safety issues, and signal evaluation.