ProSanos helps our partners gain a better understanding of the potential risks associated with a particular product, class of products, or therapeutic area. Our unique pharmacovigilance products and services assist in identifying and evaluating evidence of risk found within disparate data sources, including spontaneous reporting system (SRS) data and observational data sources such as healthcare claims data and electronic health records. We provide the following Safety and Risk Management Products and Services:

CLÆRITY^®: easy-to-use, web-based software for the investigation and management of potential safety signals in private and public spontaneous reporting system databases (learn more). CLÆRITY products and services include:

• A license to access CLÆRITY software for in-house safety investigation,
  and/or
  
• CLÆRITY-based services for in-depth analysis and/or on-going monitoring of SRS databases by ProSanos' Safety Analysts

Observational Pharmacovigilance: web-based software and underlying analysis methodology enabling routine, proactive safety signal detection and evaluation utilizing large, disparate, observational databases (learn more). Observational Pharmacovigilance products and services include:

• Observational pharmacovigilance services for in-depth analysis of a drug or class of drugs using observational (Claims and/or electronic health record) data
• A license to access SafetyWorks software for in-house signal detection and evaluation of observational data sources to supplement current pharmacovigilance practices

PV Plan: ProSanos' PV Plan software enables you to create and manage a Pharmacovigilance Plan, in accordance with the EU Risk Management Plan Template (EU-RMP). With PV Plan, you can document identified and potential safety concerns for a product, and track actions, accountable persons, status, and related milestones for characterizing those concerns and identifying additional concerns. The web based platform makes it easy for diverse and/or geographically separate teams to collaborate and share information through the product lifecycle, and to manage the Pharmacovigilance process. PV Plan enables you to document all Safety Concerns for a product, not just signals generated post product launch or by data mining. Management and QP views allow summary Safety Concern visibility.

Post-approval safety studies and registries: Implementation of post-approval safety studies and registries for active safety surveillance (learn more)