Services Overview

Clinical Trials

Regulatory

Medical & Pharmacovigilance

Nonclinical Safety

Data Management & Biostatistics

Chemistry, Manufacturing and Controls

Medical Writing

Quality Assurance

Project Management

Investigator Registry

Services: Medical & Pharmacovigilance

Medical Monitoring

To enhance regulatory compliance, a Cato Research Medical Monitor is assigned to every project and is accessible 24 hours a day, every day to handle critical situations.

The responsibilities of the monitoring physician include:

• Reporting serious adverse effects to the sponsor and to the FDA, according to Cato Research SOPs and FDA requirements
• Writing narrative descriptions of both significant and serious adverse effects for inclusion in the Final Study Reports
• Clarifying inclusion/exclusion criteria with the investigator
• Providing consultation for potential safety issues or medical concerns regarding the clinical study

Pharmacovigilance

Cato Research Pharmacovigilance provides a comprehensive range of services that meet the global demands of SAE reporting requirements for drugs, biologics, and devices from clinical studies (Phases 1 through 4) through post-marketing safety surveillance.

» Level 1 - Safety Management

Cato Research sets up the safety database and maintains all of the safety data for your products, ensuring cost-effective handling of the "ebbs and flows" in reporting and avoiding the need for an increase in head count.

» Level 2 - System Management

Using Oracle Argus Safety, Cato Research configures and validates a complete web-based safety database in a secure portal environment at a world-class managed hosting environment. Ongoing configuration, maintenance, and system upgrades are performed by experienced personnel at Cato Research, giving you complete access to all the functionality of the system without the headaches.

» Level 3 - Collaborative Safety Management

Collaborative Safety Management is a combination of Safety Management and System Management. It allows you to do as much of the safety work as you want and to work with Cato Research safety experts for individual safety roles such as data entry or safety monitor. Cato Research will perform all of your system management responsibilities. This solution is ideal if you want to be the medical or safety monitor but need additional help with other roles. In addition, you have complete access to your data just as if the system were installed in your own office.