Drug Safety Management Suite

Hosting Solutions - The benefit of 4C

Hosting Solutions - Our Drug Safety management suite is the world’s leading adverse events (AE) management suite, which is the most advanced and comprehensive AE management system enabling life sciences companies to ensure regulatory compliance, drive product stewardship, and integrate safety risk management into one comprehensive platform. The drug safety suite has been in the industry for quite some time and has been widely accepted by leading pharmaceutical, biotech, CRO’s and medical device manufacturers.

4C has developed a broad-spectrum solution to support Life Sciences companies with a comprehensive validation of regulatory requirements for our Drug Safety Management Suite. We at 4C offer a validated Drug Safety Management Suite based in SaaS environment as a comprehensive solution to our clients.

We take pride in our backup and disaster management capabilities; our backup and disaster environments are in geographically distinct locations with 99.99% uptime.

Our validation kit helps our customers in accelerating, deploying and onboarding 4C’s SaaS environment, ultimately saving time and making it a more cost-effective solution. The updates are constantly tracked, and the patches are updated without interrupting business processes, along with, providing a full proactive maintenance and support program.

Our validation kit includes:
• Validation Plan
• User Requirements
• Risk Assessment
• Functional and Design Specification
• Installation Qualification
• Operational Qualification
• Performance Qualification
• Traceability Matrix
• Validation Summary Report

Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems. It is, by definition, the practice of monitoring the effects of pharmaceutical products throughout their lifecycle during development phase as well as post marketing phase, to identify and evaluate previously unreported adverse reactions.  Along with drugs, this expands and further includes herbals, traditional and complementary medicines, blood products, biologicals, medical devices, and vaccines.

Through this analysis, we are able to identify reactions due to co-morbid conditions, concomitant drug use, or even interactions with devices that are used to administer the agent.  As this information is obtained, it is used to SAVE LIVES by reporting these events in a timely manner allowing the authorities and companies to address the population that is using the product.

With 4C’s team of competent professionals, we bring you years of experience that can help support your pharmacovigilance activities using the hosting solutions – SAFETY DATABASE SYSTEM

DruG Safety suite

  • Single case processing and expedited reporting
  • Integrated case management and workflow
  • Web-based, high-performance, high-availability system
  • Compliant with global safety requirements
  • Flexible configuration to model a wide range of business processes
Hosting solutions
Oracle Argus hosting solutions

Data protection and confidentiality

  • The entire Drug Safety Management suite, all its components and data, is partitioned by a unique enterprise ID (Client instance)
  • Users operate within this partition
  • Users can be assigned to access the enterprise for a specific client OR multiple clients (CRO case processing)
  • Users can see only the enterprise(s) for which they have access
  • If user has access to only one enterprise, then user can see only that enterprise after logging in to our drug safety management suite and any other existing enterprises (created for other clients) will not be visible at all
  • Data of each enterprise is stored separately on cloud with partition to safeguard data confidentiality and integrity


An Architecture where each company has their own instance of software application and supporting infrastructure.

Think of it like a neighborhood community.Each household can customize their property as desired. By having a single hosted instance the purchaser can tweak and customize the software to meet their needs.

Higher cost hosting solutions associated with implementation and configuration. 

An Architecture where multiple companies share the same instance to store their data in segregated databases

This instance is partitioned to prevent other tenant companies from accessing neighbor’s data. This is like high-rise building where the floor plans are generally set, but minor changes can be made to the individual units.

Low cost hosting solutions associated with shared common infrastructure, implementation and configuration. 

Multi tenant hosting solutions

4C is a comprehensive healthcare solutions provider company, specializing in Pharmacovigilance, Medical Information Call Center, Regulatory Affairs, Medical Writing, Clinical Data Management and Hosting Solutions

15 Corporate Place South
Suite 110
Piscataway, New Jersey 08854

Phone: +1 (732) 529-6989
Fax: +1 (732) 529-6990