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.

HOW ST. JUDE MEDICAL MANAGES ORACLE CLINICAL STUDIES USING ACCEL-COPY

by Eugene Sefanov

St. Jude Medical, a Fortune 500 medical device company, leverages Accel-Copy to accelerate and streamline their processes related to Oracle Clinical studies. Since 2012, St. Jude has been actively using BioPharm’s Oracle Clinical accelerator for various activities, including:

• Testing new studies and study changes that were setup in a production environment, before releasing them
• Troubleshooting production issues
• Copying specific production studies for development efforts
• Training users on studies

Please join St. Jude’s Ilya Gubernik, clinical software engineer, and BioPharm’s Michelle Engler, director of application development, for a one-hour presentation that will discuss why and how St. Jude uses Accel-Copy for its clinical studies.

Register to view the webinar: https://cc.readytalk.com/r/ot7mveyrd6kg&eom

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

USING ORACLE DATA MANAGEMENT WORKBENCH TO OPTIMIZE THE MANAGEMENT OF CLINICAL DATA FROM INFORM AND OTHER SOURCES

by Eugene Sefanov

Data Management Workbench (DMW), an application that was recently introduced as part of Oracle’s life sciences data warehousing suite, is designed to combine data from various clinical data sources, such as InForm, and transform it into standard data models. In addition to the many features DMW offers, the solution enables you to run cross-data source edit checks and perform data reviews.

Please join BioPharm’s Mike Grossman, vice president of clinical data warehousing and analytics, for this complimentary 60-minute webinar in which he will demonstrate how DMW loads, transforms, and cleans trial data from InForm 6.0 and a central lab. He will also show how to use the data for downstream reporting and analysis.

Register to view the webinar: https://cc.readytalk.com/r/xzgb9ola6ji1&eom

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

BENEFITS OF OUT-OF-THE-BOX CLINICAL DEVELOPMENT ANALYTICS FOR SIEBEL CLINICAL

by Eugene Sefanov

Oracle’s Clinical Development Analytics (CDA) solution can take your clinical trial data to a whole new level; with its dashboards, reporting modules, and analyses, it enables you to slice, dice, and view your data in meaningful ways. But, what exactly do you get with CDA out-of-the-box for Siebel Clinical? How useful is CDA functionality when plugged into Siebel Clinical with no additional configuration?

In this free one-hour presentation, BioPharm’s Mike Grossman, VP of clinical data warehousing and analytics, and Param Singh, VP of clinical trial management solutions, will answer these questions and provide a demonstration of CDA’s features.

Register to view the webinar: https://cc.readytalk.com/r/6gkb9zasp7hj&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.

Creating an Account for Oracle Clinical (OC), Remote Data Capture (RDC), and Thesaurus Management System (TMS)

by Eugene Sefanov

Learn how Accel-Account Manager can help your organization create and manage Oracle Clinical, Oracle RDC, and Oracle TMS accounts.

A PEEK INTO A MUST-HAVE ADD-ON SOLUTION FOR ORACLE CLINICAL

by Eugene Sefanov

Most of the companies that have seen Accel-Copy understand the value it provides and the productivity boost it gives to teams that work with Oracle Clinical. We invite you to experience it for yourself, too.

Please join BioPharm Systems’ Michelle Engler, the creator of Accel-Copy, for a free one-hour webinar, in which she will discuss and demonstrate the features and benefits of this time-saving solution meant for companies that:

• Need to archive studies in their clinical systems production environment
• Long for an easy way to create and refresh a training environment
• Struggle with the complexities of migrating studies to a new environment
• Desire the power of diagnosing production issues in a test environment without having to involve a database administrator

Register to view the webinar at https://cc.readytalk.com/r/2v9j6mqme6w2.

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

SELF-SERVICE ACCOUNT MANAGEMENT FOR ORACLE CLINICAL, REMOTE DATA CAPTURE, AND THESAURUS MANAGEMENT SYSTEM

by Eugene Sefanov

With so many organizations using Oracle Clinical, Remote Data Capture (RDC), and Thesaurus Management System (TMS), it is no surprise BioPharm Systems’ clinical account management solution, Accel-Account Manager, has generated a tremendous amount of interest and is now already in use at several organizations.

Accel-Account Manager, a fully-documented, validated and GxP-compliant application, provides the ability for creating, updating, resetting, locking, unlocking, and mass creation of Oracle Clinical, RDC, and TMS user accounts. In addition, the application supports the management of database roles, OC study access, RDC study site privileges, and Oracle profiles. With Accel-Account Manager, end-users even have the ability to reset passwords, retrieve accounts, and manage security questions autonomously. An administrator can even create multiple accounts from an Excel spreadsheet and apply RDC security settings to several accounts with one simple click.

Please join Michelle Engler, the creator of Accel-Account Manager, for this one-hour presentation that will include a live demonstration of this all-in-one solution for managing your OC, RDC, and TMS accounts.

Register to view the webinar at https://cc.readytalk.com/r/439uw4k1ogea.

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

THE FUTURE OF ORACLE CLINICAL, REMOTE DATA CAPTURE, AND THESAURUS MANAGEMENT SYSTEM WITH BIOPHARM SYSTEMS AND ORACLE’S DIRECTOR OF PRODUCT STRATEGY

by Eugene Sefanov

It is no secret that most sponsors and clinical research organizations consider Oracle Clinical (OC), Remote Data Capture (RDC), and Thesaurus Management System (TMS), the most comprehensive clinical systems on the market.

It is also no surprise that even with the arrival of numerous new systems since OC’s inception in the mid-1990s, OC, RDC, and TMS have continued to thrive, due to their affordability, scalability, and improved system functionalities related to the complex clinical study design, performance, interface and flexibility requirements of today’s clinical trials.

Whether your organization conducts electronic clinical trials or paper clinical trials, these systems simply provide the best return-on-investment.

Please join BioPharm Systems’ director of client relations, Vicky Green, and special guest from Oracle, director of product strategy, Chris Huang, for a free 60-minute webinar in which they will:

• Discuss the future of OC/RDC/TMS
• Share a sneak peek into the improved features in the current release of OC/RDC/TMS
• Highlight Oracle’s continued commitment to the development and support of OC/RDC/TMS
• Host a live Q&A session with webinar participants

Register to view the webinar at https://cc.readytalk.com/r/umijl2vtq2mm.

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

FREE WEBINAR: HOW TO EASILY COPY, MIGRATE, AND ARCHIVE ORACLE CLINICAL STUDIES AND GLOBAL LIBRARIES

by Eugene Sefanov

Is your clinical systems production environment bloated with studies that should be archived? Do you long for an easy way to create and refresh a training environment? Are you struggling with the complexities of migrating studies to a new environment? Does your clinical team desire the power of diagnosing production issues in a test environment without having to involve a database administrator? Look no further. Accel-Copy can do all this and more!

BioPharm Systems has developed Accel-Copy to be a versatile tool that allows your clinical environment to be managed by your clinical team more effectively.

Out of the box, the application provides the following features and benefits:

Database Management:

• Migrate select global library domains/studies
• Archive studies/global library to an archived instance

Support and Training Functionality:

• Refresh studies or parts of studies from production to development or QA
• Refresh patient data/discrepancies from production to development or QA
• Create/refresh training instance studies or parts of studies

Clinical Administration and Configuration:

• Synchronize reference code lists among environments
• Refresh sites and investigators among environments without replication
• Manage organization units, regions, program, and projects across environments from a single source

Data Quality:

• Perform field by field comparison of database data from before and after a migration/upgrade
• Copy global library domains from production to QA
• Copy a new study to production from QA

The application is fully documented, validated, and GxP compliant.

Please join Michelle Engler, the creator of Accel-Copy, for this one-hour presentation that will include a live demonstration of this powerful solution.

June 13, 2012 at 9:00 a.m. (Eastern Time): https://cc.readytalk.com/r/n5puvptn7p4f

June 13, 2012 at 2:00 p.m. (Eastern Time): https://cc.readytalk.com/r/dlgyb0hyp3xw

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