What is PRIMO?

PRIMO is a web-based data capture solution that allows you to capture, manage, and triage potential adverse event reports in a single, standardized
fashion.

Reports are entered into PRIMO using an intuitive, highly interactive data entry system or electronically transferred from your call center. Once entered, reports are available for review and triage. If the inbound report meets criteria for reporting, you can promote it to your global pharmacovigilance system. Once the report has been promoted to your pharmacovigilance system, PRIMO offers ongoing remote management and compliance functions. Authorized users can review cases using the review functions. In addition remote users can review pending local submissions and track the submission date.

PRIMO provides a streamlined mechanism to capture, manage, and triage all possible adverse event, product complaint, and pregnancy registry reports from all of your call centers, remote offices, and partners. Reports are triaged and automatically transferred to your global pharmacovigilance system. Once transferred, PRIMO allows report users to review and track local submissions. PRIMO provides a single, auditable source for all of your input streams.

Features

Report and Capture Management

Capture reports directly in PRIMO using intuitive data entry screens.

Import new reports using inbound E2B messages.

Automatically transfer inbound contacts from your Call Center software to PRIMO.

Global Case Review

Once promoted, remote users can continue to participate in the management of the case through the Case Review process.

Reviewed cases can be approved or returned to the workow with comments and feedback.

Local Submission

Remote users can use PRIMO to review pending reports. Reports can be viewed then printed locally or faxed to local regulators.

Once submitted, remote users can directly capture the submission data or justication for locally downgrading the case.

Administration

User and User Group management allows you to control functional and data access.

Configuration management of reference lists and other user interface features.

Document Management

Go paperless by attaching all your source documents to a PRIMO report.

Manage outbound correspondence and follow-up.

Metrics Management

Detailed report volume and timeliness data.

Comprehensive reports of promotion decisions.

Manage

Push PRIMO reports through a flexible workow of your design.

Promote the report to your global pharmacovigilance system or mark the report for No Action. PRIMO captures a justication for any report that is not promoted to your global system.

Promotion automatically transfers the report using an E2B interface or direct database connection.

Technology

PRIMO can be deployed on a number of web server platforms, including WebLogic, Apache and TomCat running on any operating system. PRIMO supports Oracle 10g and 11g databases.

Implementation

PRIMO implementation is straightforward and November Research offers a full complement of consulting services to support the deployment of PRIMO within your standardized data input process.

Pricing

PRIMO pricing is on a named-user basis, priced to scale with your organization.
Site-wide and other licensing options are negotiable. Customers receive the rights to deploy the software as desired and have access to all software upgrades as they are made available from November Research Group.
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