ProSanos provides a suite of pharmacovigilance services that range in complexity & delivery models and are designed for clients who need elaborate analysis capabilities without the overhead of implementing new technologies & processes. Available as ad-hoc projects or outsourced services, all services are delivered by senior safety and medical professionals using our state-of-the-art systems and processes. Based on our Roadmap to Comprehensive Surveillance, clients can choose the level of sophistication and scope based on their unique requirements including:

Product Safety Profiles: Level 1 - Qualitative Analysis

Manual case level analysis for determining the potential for a new serious safety risk. Ideal for clients with new products or low volumes who are doing manual AE case processing or outsourcing.

Signal Detection: Level 2 - Basic Quantitative - Internal Data

Analyzes AE cases of internal data (Post Makreting or Clinical). First level of statistical analysis provides clients with experience in the analytical process and understanding of the results valuable in evaluating technology solutions. Provides clients with advanced warning of potential issues prior to regulatory intervention.

Signal Adjudication: Level 3 - Advanced Pharmacovigilance / Risk Management

Analyzes and classifies all potential safety signals with a given product or group of products in AERS or VAERS that could be picked up by a regulatory agency. Helps clients resolve a backlog of SDRs in a cost-effective outsource model. Provides clients with insight to potential regulatory perspective of product data without the need to invest in a software solution.

Observational Studies: Level 4 - Highest Level of Pharmacovigilance

Leverages observational data to test hypotheses generated by the analysis of spontaneous data sources.

Regulatory Response: Custom Consulting Engagement

A review of both internal company data as well as what is visible in public data sources. Includes Statistical Analysis and optional Medical Assessment. Rapid and thorough response to regulatory action utilizing the same technologies and data sources as the agencies. An objective third party perspective from an organization that is highly experienced with product safety evaluation.

Audits & Assessments

A comprehensive review of the people, processes, and technologies used in day-to-day Pharmacovigilance operations. Focuses on compliance with regulations and industry best practices as well as operational efficiency. Conducted by experienced PV and technology professionals.

Strategy & Program Development

Design and implementation of a long-term strategy for comprehensive pharmacovigilance and risk management that evolves with company needs and focus. Increases operational efficiency through a documented plan based on projected product surveillance requirements.