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.

Identifying Safety Signals by Data Mining the FDA Adverse Event Reporting System with Oracle Empirica Signal

by Eugene Sefanov

Ever since the European Union (EU) introduced new legislation that requires life sciences companies to proactively detect, prioritize, and evaluate safety signals, there has been an increased interest, not only from sponsors in the EU, but globally, in pharmacovigilance systems that can assist with the signal management process.

Please join BioPharm’s Christina Wocosky, an expert in signal detection and management, for a free one-hour webinar in which she will discuss how your organization can use Empirica Signal, Oracle’s state-of-the-art signal detection system to data-mine the existing FDA Adverse Event Reporting System (FAERS) to determine safety signals. After attending this presentation and demonstration, registrants will better understand how this solution can be used in daily pharmacovigilance activities.

Register to view the webinar at https://cc.readytalk.com/r/7ekwxbm7q33t&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.

INTEGRATING ORACLE ARGUS SAFETY WITH OTHER CLINICAL SYSTEMS USING ARGUS INTERCHANGE’S E2B FUNCTIONALITY

by Eugene Sefanov

Over the past few years, companies conducting clinical trials have increasingly been interested in integrating their pharmacovigilance systems with other clinical and safety solutions to streamline their processes.

Please join BioPharm Systems’ Dr. Rodney Lemery, vice president of safety and pharmacovigilance, for a one-hour webinar in which he will discuss the ability to integrate Oracle’s Argus Safety with other applications using the safety system’s inherent extended E2B functionality.

This presentation will cover two Argus Safety integration projects – one that has been completed and one that is ongoing. The discussion will include the conceptual framework for these integration bridges and will identify issues, concerns, and their respective mitigation strategies.

After attending this tutorial, you will have an increased understanding of Argus’ extended E2B capabilities and the typical points of discussion for similar projects.

Register to view the webinar: https://cc.readytalk.com/r/x4mjn5dm2r06&eom

To learn more about BioPharm, 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.

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.

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.