USING JREVIEW TO ANALYZE CLINICAL AND PHARMACOVIGILANCE DATA IN DISPARATE SYSTEMS

by Eugene Sefanov

Sponsors and CROs naturally rely on various clinical and safety systems from a multitude of software vendors. However, continuously accessing disparate sources for the reporting, analysis, and monitoring of data can be a treacherous undertaking, if you don’t have a solution that connects to them right out of the box.

That’s where JReview comes in. For almost two decades, life sciences companies, research organizations, in addition to the government, have relied on JReview for the comprehensive analysis and monitoring of clinical and pharmacovigilance data.

The analytics solution works with many Oracle Health Sciences applications, including Argus Safety, Oracle AERS, Oracle Clinical (OC), Remote Data Capture (RDC), Thesaurus Management System (TMS), InForm, Life Sciences Data Hub (LSH), and Clinical Development Center (CDC). JReview also works with non-Oracle solutions, such as ARISg, Medidata Rave, and SAS Drug Development.

Please join Integrated Clinical Systems’ Eric Herbel and BioPharm’s Vicky Green for a free one-hour webinar that will discuss:

— The features and benefits of JReview, including the new functionality in v10.0 (e.g., risk-based monitoring analytics reporting on the clinical data itself, etc.)

— Benefits of using JReview for:

            — Reporting and query of your clinical data

            — Supplying internal and/or external users/sponsors information

            — Providing a secure way for your internal users and/or sponsor users to access the clinical dataclinical data

— Examples of how customers use JReview with OC/RDC

— The implementation process and options

— Your own questions and challenges

Register to view the webinar: https://cc.readytalk.com/r/sayo292vuaj2&eom

For more information about BioPharm Systems, please visit www.biopharm.com.

MIGRATING FROM EMPIRICA TRACE TO ARGUS SAFETY: THE REASONS FOR THE MOVE

by Eugene Sefanov

Oracle added Empirica Trace to its product portfolio when it acquired Phase Forward in 2010. Although the safety database has successfully helped organizations meet their requirements over the years, it lacks many user-friendly features and the deep functionality that is essential in today’s highly-regulated environment. Whether the capabilities relate to system management, coding, E2B, languages, or reporting, there are many differentiators in Argus Safety that current Empirca Trace users will be able to appreciate.

Please join BioPharm’s Dr. Rodney Lemery, VP of safety and pharmacovigilance, for a free one-hour webinar in which he will:

• Compare Argus Safety to Empirica Trace
• Cover the options of effectively migrating to Argus Safety

Register to view the webinar: https://cc.readytalk.com/r/73vghet75yx8&eom

For more information about BioPharm Systems, please visit www.biopharm.com.

Using Oracle Argus Safety to Comply with Japan’s Safety and Pharmacovigilance Regulations

by Eugene Sefanov

Life sciences companies, or their affiliates, with a presence in Japan, must comply with the country’s stringent safety and pharmacovigilance regulations. To meet the reporting and submission requirements, typically set by the Pharmaceuticals and Medical Devices Agency (PMDA) and Ministry of Health, Labor and Welfare (MHLW), organizations often choose to deploy sophisticated adverse event reporting systems to help streamline their drug safety and pharmacovigilance operations.

Oracle’s Argus Safety, coupled with the Argus Safety Japan (Argus J) module, is one of the few truly global systems that can meet the critical needs of sponsors and CROs doing business globally, and specifically in Japan.

Please join BioPharm’s KC Katsuyama, director of safety and pharmacovigilance, APAC, for a free one-hour webinar in which he will discuss the features and benefits of Argus J.

Register to view the webinar at https://cc.readytalk.com/r/lc2nzo075hn8&eom

For more information about BioPharm Systems, please visit www.biopharm.com.

How Oracle Argus Safety Migrations Work

by Eugene Sefanov

Is your organization considering migrating to Argus Safety, Oracle’s comprehensive safety and pharmacovigilance system? Then you probably already know that moving and reformatting legacy adverse event cases can be a major bottleneck.

BioPharm, with our partner, Valiance, can quickly automate and streamline many aspects of the migration and implementation process without resorting to custom scripts, existing APIs, and time-consuming manual tasks. From the assessment and strategy to the complete migration and verification of adverse event cases from your source system (e.g., AERS, ARISg, Excel, Trace, Custom, etc.), leveraging our tried-and-true methodologies and technologies helps you accelerate the entire process with confidence.

Please join BioPharm’s Dr. Rodney Lemery and Valiance’s Richard Higger for a free one-hour webinar that will explore:

• The types of risks and challenges associated with safety data system migrations, including migrations to Argus Japan
• How to successfully approach a safety and pharmacovigilance system migration and implementation project
• The benefits of pre-configured migration software and automated 100% migration testing
• Examples of past migration and implementation projects
• Your own migration questions and challenges

Register to view the webinar at https://cc.readytalk.com/r/c281688i2iki&eom

For more information about BioPharm Systems, please visit www.biopharm.com.

EVALUATING AND INVESTIGATING DRUG SAFETY SIGNALS WITH PUBLIC DATABASES

by Eugene Sefanov

In this one-hour webinar, BioPharm Systems’ Dr. Rodney Lemery, vice president of safety and pharmacovigilance, will review a number of public databases available to use during the evaluation and investigation of identified safety signals. The discussion will focus on the use of free and paid longitudinal healthcare databases available online. After attending this presentation, you will better understand how these data sources can be used in your daily PV work.

Agenda Highlights:

• Overview of Signal Management
• Overview of Epidemiology
• Review of free and paid databases

Register to view the webinar: https://cc.readytalk.com/r/eagsm4a1unid&eom

To learn more about BioPharm, please visit www.biopharm.com.

A Brief Guide to the FDA Drug Approval Process

by Eugene Sefanov

This infographic describes the FDA drug approval process.

MEDICAL CODING WITH MEDDRA

by Eugene Sefanov

MedDRA is a global dictionary used by companies for regulatory activities. The dictionary, complete with clinically validated terminology, is used to classify adverse event information related to the use of drugs, devices, and other therapies. Coding the data to a standard set of MedDRA terms enables health authorities and the life sciences industry to more readily exchange and analyze data.

MedDRA is considered the international standard for adverse event classification. However, while the data volume and standardization capabilities offered by the dictionary can provide significant benefits, the multi-axial design and data specificity can introduce considerable challenges that could lead to the inaccurate classification of data.

Join BioPharm Systems’ Dr. Rodney Lemery, vice president of safety and pharmacovigilance, for this free one-hour webinar that will explore the best practices for medical coding using MedDRA.

Register to view the webinar at https://cc.readytalk.com/r/fqfuit5ql7qh.

For more information about BioPharm Systems, please visit www.biopharm.com.

FREE WEBINAR: STREAMLINING A GLOBAL LIFE SCIENCES COMPANY’S PHARMACOVIGILANCE OPERATIONS

by Eugene Sefanov

As the focus on international product safety regulations increases, life sciences organizations must globalize and enhance their safety and pharmacovigilance operations in order to successfully navigate through the challenges they are presented with.

Join BioPharm Systems’ Dr. Rodney Lemery, vice president of safety and pharmacovigilance, for this free one-hour webinar that will discuss a major pharmaceutical company’s pharmacovigilance globalization initiative that helped standardize and streamline its operations.

Several topics that will be discussed include:

• SOP Integration
• Standardization of Local Practices
• Departmental Coordination
• Varying Reporting Requirements

Register to view the webinar at https://cc.readytalk.com/r/14um1yqp5jps.

For more information about BioPharm Systems, please visit www.biopharm.com.

Free Webinar: Merging Multiple Drug Safety and Pharmacovigilance Databases into One Global Oracle Argus Safety System

by Eugene Sefanov

Many sponsors and CROs rely on an IT infrastructure that includes multiple disconnected safety and pharmacovigilance systems that vary by region and vendor. Although merging these systems into a single global solution may seem daunting and provide you with many technical challenges, it could be a crucial goal on the horizon for your organization.

Please join BioPharm Systems’ Dr. Rodney Lemery, vice president of safety and pharmacovigilance, for this free one-hour webinar in which he will review a recent project for a top pharmaceutical company that entailed the merging of multiple drug safety systems into one global Argus Safety pharmacovigilance system.

Specific topics that will be examined include:

• Adverse Event Case Migration
• Merging and Configuring
• Data Cleansing and Consistency
• Configuring Reporting Rules

Register to view the webinar at https://cc.readytalk.com/r/nu2vem0xprkr.

For more information about BioPharm Systems, please visit www.biopharm.com