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Posts tagged with "argus safety"

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 ORACLE AERS TO ARGUS SAFETY: THE REASONS FOR THE MOVE

by Eugene Sefanov

Not too long ago, Oracle AERS was the most widely-used adverse event report system. However, with the acquisition of Relsys and its safety and pharmacovigilance system in 2009, Argus Safety quickly became the go-to software for most life sciences companies. Its capabilities and comprehensiveness simply were, and continues to be, unmatched.

Companies currently using Oracle AERS have expressed interest in moving to Argus Safety, but want to know more before making the jump. This webinar is meant to do just that – answer your common questions.

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 AERS
  • Cover the options of effectively migrating to Argus Safety

Register to view the webinar: https://cc.readytalk.com/r/797ko39igeyx&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.

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.

What is Oracle Argus Safety?

Oct 3

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.

Oct 3

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.

[Infographic] Multi-Tenancy in Argus Safety 7.x for AROs and CROs

[Infographic] Multi-Tenancy in Argus Safety 7.x for AROs and CROs

May 6

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

FREE WEBINAR: BUSINESS AND OPERATIONAL RISKS IN CLINICAL AND SAFETY: APPLYING APPROPRIATE TECHNOLOGY AND APPROACHES TO MITIGATE RISK

by Eugene Sefanov

All business processes are subject to some level of risk. Key to the long term viability of any company is the critical need to identify the risks, quantify them, minimize them, and have a clear plan for dealing with any residual risks.

Organizations try to mitigate risks by implementing systems that support the company’s business processes. Commercial software systems that are available from vendors such as Oracle include many capabilities which, if implemented properly, greatly reduce the risks in the business process.

The implementation of complex systems is, in itself, a risky process. Organizations like BioPharm Systems have been able to use their wide range of experience to develop pre-configured and pre-validated solutions that help reduce the risks during the implementation of a clinical trial management system (CTMS) and a safety system.

This one and a half-hour webinar will provide an overview of business risks related to clinical and safety systems and will illustrate how the risks inherent in implementing complex CTMS and safety systems can be significantly reduced.

View a recording of the webinar at https://cc.readytalk.com/r/9ho7q3hcfcbr.

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

Oct 7

Free Webinar: Argus Safety: Planning for the New Individual Case Safety Report (ICSR) International Standard and Upcoming ICSR Reporting Changes

by Eugene Sefanov

The new ISO Individual Case Safety Report (ICSR) standard is being finalized in 2011. A major revision of the ICH E2B guideline is progressing based on the new ICSR standard with an ICH step 2 consultation of the ICH E2B(R3) Implementation Guide expected by the end of June 2011. An overview of the proposed changes to the ICSR Final Draft International Standard (FDIS) and its implementation will be discussed, along with the expected changes to the ICSR reporting in the context of the new European pharmacovigilance legislation.

Join BioPharm Systems’ Andrew Mitchell, EMEA safety and pharmacovigilance practice lead, for this one-hour presentation that will include:

  • Discussion of the upcoming ISO Individual Case Safety Report (ICSR) standard known as ICH E2B(R3)
  • Electronic reporting of ICSRs and EudraVigilance in the context of the new European pharmacovigilance legislation
  • Using Argus Safety to comply with the information and regulations above and how this affects your upgrade planning

View a recording of the webinar at https://cc.readytalk.com/r/1arwmwvagd2p.

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

Oct 7

Free Webinar: Oracle Argus Safety and Oracle Argus Safety Japan: A Unified Solution that Facilitates Compliant Reporting to a Japanese Regulator

by Eugene Sefanov

Achieving complete and efficient reporting of adverse drug reactions is a critical goal for all companies involved in developing and delivering medicinal products to the world’s population. These companies include pharmaceutical, biotech, medical device, contract research organizations (CROs), charitable and not-for-profit organizations and academic institutions.

While the challenge of efficient and effective safety reporting to two of the major regulatory agencies – FDA and EMA – is substantial, the additional challenge of reporting to the Japanese regulatory authority, the PMDA, in a way that integrates with an existing safety reporting process and function is significantly greater.

Argus Safety and Argus Safety Japan together help you to meet these challenges by providing a single global database and integrated workflow process for superior safety reporting capabilities.

This webinar will be of interest and relevance to all organizations that need a robust and proven safety system to meet their global regulatory reporting requirements. It will be of particular interest to those companies that have a requirement to report safety events to the PDMA in Japan in a timely and efficient manner that is integrated within their global safety reporting functions. 

This webinar will provide you with:

  • An overview and the business benefits of Oracle Argus Safety Suite
  • The business benefits of Oracle Argus Safety Japan and integrating it with Oracle Argus Safety
  • The benefits of a single global safety database and why Oracle Argus Safety Suite is the right solution for it

Tuesday, September 13, 2011 @:

7:00 a.m. US Pacific time
8:00 a.m. US Mountain time
9:00 a.m. US Central time
10:00 a.m. US Eastern time
15:00 UK time
16:00 Central European time

View a recording of the webinar at https://cc.readytalk.com/r/m2u0hnfh8pnm. 

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

Oct 6

Free Webinar: Business and Operational Risks in Clinical and Safety: Applying Appropriate Technology and Approaches to Mitigate Risk

by Eugene Sefanov

All business processes are subject to some level of risk. Key to the long term viability of any company is the critical need to identify the risks, quantify them, minimize them, and have a clear plan for dealing with any residual risks.

Organizations try to mitigate risks by implementing systems that support the company’s business processes. Commercial software systems that are available from vendors such as Oracle include many capabilities which, if implemented properly, greatly reduce the risks in the business process.

The implementation of complex systems is, in itself, a risky process. Organizations like BioPharm Systems have been able to use their wide range of experience to develop pre-configured and pre-validated solutions that help reduce the risks during the implementation of a clinical trial management system (CTMS) and a safety system.

This one and a half-hour webinar will provide an overview of business risks related to clinical and safety systems and will illustrate how the risks inherent in implementing complex CTMS and safety systems can be significantly reduced.

Thursday, November 17, 2011 @:

7:00 a.m. US Pacific time
8:00 a.m. US Mountain time
9:00 a.m. US Central time
10:00 a.m. US Eastern time
15:00 UK time
16:00 Central European time

View a recording of the webinar at https://cc.readytalk.com/r/9ho7q3hcfcbr. 

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