PHARMACOVIGILANCE IN THE CLOUD

SCHEDULING & DASHBOARD

The vrSafety has a powerful scheduling facility, which

clearly delineates work in progress, due dates and cases

that require immediate attention. Users are given clear

visual feedback via a familiar user interface and color coded

events. The dashboard displays a summary of currently

active cases in various categories – including cases created

in the last week and/or month, cases currently in edit and

those that are due today. Users are able to see at a glance

what their work load and priorities are for the day or the

week. The use of a ribbon throughout the application makes

the user’s experience very similar to using familiar tools

such as Microsoft Office 2010™.

SECURELY MANAGE YOUR SAFETY SYSTEM IN T HE CLOUD

Adverse Event Management in the Cloud

The release of the vrSafety provides Life Sciences organizations

with the industry’s first “built for the Cloud” safety and

pharmacovigilance application. The implications for the industry

are dramatic. The benefits of the global Microsoft Azure Cloud

based services infrastructure allows globally dispersed

companies to use a single application to manage all their safety

cases in a single standards based solution. By using the

Windows Azure platform, the vrSafety gives complete control of

the safety systems without requiring customers to set up

complex, costly, on-premises infrastructure. New clients can

have their environment configured and available in 10 days or

less.

EXPEDITED AND AGGREGATE CASE REPORTING

As part of a comprehensive approach to risk mitigation, vrApp -

Safety provides a wide variety of expedited and aggregate reports

to aid in global adverse event reporting, including the FDA CIOMS,

PSUR, ASR and other major international reporting forms. For

electronic exchange, VrSafety supports the transmission of E2B

files with recipient-based mapping for compliance with local

agencies.

GLOBAL ACCESS AND SECURITY

WITHOUT INFRASTRUCTURE

Simple

Functional

Compliant

Standards Support:

- MedDRA - CIOMS - E2B

OPEN INTEGRATION

vrSafety is an open system based on industry standard architecture. It can be

integrated with third-party systems such as regulatory, clinical, document management

and medical information systems to improve collaboration between departments and

eliminate transcription errors.

Automated, Intuitive

Reduce safety risk for multiple product

lines—drugs, devices, vaccines &

combination products.

Detailed audit trail and audit trail reporting

eSubmission gateway with audit trail

Automated safety reports

Automated case processing

Simple, intuitive search builder

Automated medical review process

No infrastructure to install or support

Pay-as-you-do pricing

Buy what you need

Access the application from anywhere

CASE HANDLING/WORKFLOW

Through a web browser, employees can

search for, or create and manage, safety

cases utilizing powerful standardized

workflows. The vrSafety will enable the

capture, review and submission of safety

reports accurately, quickly and efficiently

thus ensuring optimum productivity and

regulatory compliance - even with globally

dispersed personnel. The workflows allow

users to route cases automatically for

efficient processing. Incoming cases can be

automatically placed in the appropriate

workflow, and routed based on company

SOPs and policies. Users are able to track

who is responsible for specific actions and

monitor response timeframes for all key

activities such as data entry, assessment,

coding and reporting for full

compliance. Alternatively, cases managers

are able to assign cases to individual team

members and review the activities of each

individual.

CASE QUERYING & ANALYSIS

An advanced search tool allows users to

easily create complex queries for case

retrieval, analysis and reporting. The query

engine allows users to search all VrSafety

fields using Boolean logic and supports

case-insensitive, free-text searches.

Support of the published MedDRA SMQs is

also provided*. Once a search is executed it

is possible to perform a variety of

operations, such as case review, and to run

batch operations, including validations, case

updates and report generation. Users are

able to save searches and re-run them as

needed.

* Clients must purchase appropriate MedDRA license.

Affordable Vigilant, Flexible,

Safety Systems

Case Management

About Umthunzi

UMTHUNZI is a company dedicated exclusively to Life Sciences. We facilitate and

streamline the manner in which research is conducted - accelerating drug

development, while cutting costs, and bringing safer therapies to those that need

them faster and more affordably. Our vrApps are affordable purpose built

applications that are designed to be affordable, functional and address important

aspects of a drug or devices life cycle.

Contact Us Email: info@umthunzi.com Phone: 404-248-7101