MAKING ORACLE CLINICAL AND REMOTE DATA CAPTURE 4.6 FEATURES WORK FOR YOU

by Eugene Sefanov

Implementation of Oracle Clinical (OC) and Remote Data Capture (RDC) 4.6 provides life sciences organizations with more options for designing clinical trials. This most recent version of OC/RDC offers features that support adaptive trials and provide ease of use for the end user, while better securing a sponsor’s data.  Join BioPharm Systems’ Principal Consultant, Mari Clovis, for this one-hour session to learn about these new features and other updates:

• Defining conditional logic within forms
• Using flexible study options for adaptive trials
• Restricting access to selected forms
• Hiding and preventing updates to queries based on user roles
• Miscellaneous updates

This session will include a live demonstration of an OC/RDC 4.6 system.

View a recording of the webinar at https://cc.readytalk.com/r/gsw0mhrqpw83.

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

CLINICAL TRIAL MANAGEMENT SYSTEMS 101

by Eugene Sefanov

If you’ve ever wondered what a CTMS is, how one is beneficial, or how to select and implement one, then this webinar is for you. Join BioPharm Systems’ Param Singh, vice president of clinical trial management solutions, for this one-hour session that will provide you with a basic understanding of clinical trial management systems.

This webinar will answer the following questions:

• What is a CTMS?
• Which types of organizations need one?
• How do you choose one?
• How do you decide on an implementation strategy?
• What are the best practices to consider for implementation?
• What are some implementation pitfalls to avoid?

View a recording of the webinar at https://cc.readytalk.com/r/1ged4jb5ja46.

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

SIEBEL CLINICAL FOR SMALL AND MEDIUM-SIZED ORGANIZATIONS

by Eugene Sefanov

ASCEND On-Demand is a pre-configured and enhanced version of Oracle’s Siebel Clinical that uses a software-as-a-service (SaaS) platform. Its subscription-based pricing model makes it attractive to life sciences organizations of all sizes – regardless of how many users you have.

Join BioPharm Systems’ Param Singh, Vice President of Clinical Trial Management Solutions, for this one-hour session on what makes Siebel Clinical the top clinical trial management system (CTMS) in the industry and how you can start using it for significantly less than the total cost of a typical implementation.

View a recording of the webinar at https://cc.readytalk.com/r/w45sfpqhif5i.

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

THE BENEFITS OF SIEBEL CLINICAL INTEGRATION

by Eugene Sefanov

You’ve implemented state-of-the-art enterprise systems for different work functions, but they don’t talk to each other. Now what? Savvy organizations know how to maximize their IT investments – they automate interfaces. Join BioPharm Systems’ Param Singh, Vice President of Clinical Trial Management Solutions, for this one-hour session on why and how you should integrate Siebel Clinical with these systems:

• EDC – Import subject and subject visit data
• Financial – Export payment requests and import processed payment updates
• IVR – Import subject and subject visit data
• Safety – Automatically trigger serious adverse event creation
• EDM – Auto-link document tracking records to electronic document storage records
• Clinical Data Warehouse – Create dashboards and reports based on key metrics and performance indicators
• …or even the CTMS at your preferred CRO or partner organization.

This session will include a live demonstration of an integrated system.View a recording of the webinar at https://cc.readytalk.com/r/6fr6ehdljrtb.

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

LEVERAGING ORACLE’S CLINICAL DEVELOPMENT ANALYTICS TO BOOST PRODUCTIVITY AND REDUCE COSTS

by Eugene Sefanov

Oracle’s Clinical Development Analytics (CDA) is a comprehensive analytics solution that provides life sciences sponsors and CROs operational insight into their clinical studies, projects, and programs. Join BioPharm Systems’ Michael Grossman, vice president of clinical data warehousing and analytics, for this one-hour session on CDA to learn how it can be leveraged to answer specific critical business questions by bringing together information from both data management and clinical operations.

You will learn how CDA can:

• Provide insight where and when you need it
• Increase productivity and reduce costs
• Improve clinical operations and data management effectiveness

View a recording of the webinar at https://cc.readytalk.com/r/o00dmtuqp4tl.

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

INCREASE ROI THROUGH AN EFFECTIVE CTMS TRAINING PROGRAM

by Eugene Sefanov

User adoption is the key to achieving a rapid ROI for your CTMS and the key to user adoption is an effective training program. Such training programs are based on a careful analysis of an organization’s culture and the characteristics of its end-users. All training programs should be multi-faceted, comprehensive, and long-term in scope. But, depending on the organization, the details of a program should be tailored to meet the needs of the end-users and the organization as a whole. Effective CTMS training programs leave users feeling well-equipped to begin using the system and fully supported as they master it.

Join BioPharm Systems’ Param Singh, vice president of clinical trial management solutions, for this one-hour presentation on a variety of methods for achieving these goals and discussion on how to choose from these methods to build a training program that is right for your organization.

This webinar will answer the following key questions:

• How do adults learn?
• What are the different approaches to software training?
• Which approaches make sense in different types of organizations?
• How can we best prepare users to start using the system?
• How can we continue to support users over time?

View a recording of the webinar at https://cc.readytalk.com/r/y6nke8bfcknt.

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

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.

SIEBEL CLINICAL BEST PRACTICES: POST IMPLEMENTATION

by Eugene Sefanov

Has your organization recently implemented Oracle’s Siebel Clinical as their CTMS? Or are you preparing to do so, or perhaps beginning to consider it? Regardless of your stage in the process, organizations that follow a set of best practices with Siebel Clinical enable users and administrators to operate efficiently and effectively. Best practices maximize the system’s functionality, maintain consistent business processes, and ensure clean records. In short, they save you time and money.

Join BioPharm Systems’ Alice Crawford, senior consultant, clinical trial management solutions, for this one-hour session that will examine various best practices that life sciences organizations should consider once they have implemented a CTMS.

This webinar will cover best practices in the following areas:

• SOPs
• User responsibilities and positions
• Record format conventions
• Record entry and deletion
• Template creation and use
• Site visits and monitoring reports
• Protocol amendments
• Investigator payments
• Change control tools
• Querying and ad hoc reports
• And much more!

View a recording of the webinar at https://cc.readytalk.com/r/lk61te8ia7gv.

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

DEMONSTRATION OF SIMPLE FORMS, AN ELECTRONIC DATA CAPTURE (EDC) SOLUTION DESIGNED TO BE USED WITH ORACLE CLINICAL

by Eugene Sefanov

Simple Forms, a low-cost and intuitive EDC system, has been implemented at biopharmaceutical, medical device, and contract research organizations since 2005. The solution is designed to be used with Oracle Clinical, with or without Remote Data Capture (RDC).

Some of the features and benefits:

• Due to the simplicity of the system, no training is required
• Choose from 5 languages with a click of a button (English, French, German, Italian, and Spanish)
• E-mail specific users upon submission of a form to help keep data entry on track
• Collect survey data
• No plug-ins required
• No 3rd party software required, aside from Oracle Clinical
• Use with any operating system and browser

Join Michelle Engler, the chief architect of Simple Forms, for a one-hour presentation that will include a live demonstration of this EDC solution. If you prefer a private demonstration at your convenience, please let us know at info@biopharm.com.

View a recording of the webinar at https://cc.readytalk.com/r/3inun3sr5oc5.

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

LEVERAGING ORACLE’S LIFE SCIENCES DATA HUB (LSH) TO ENABLE DYNAMIC CROSS-STUDY ANALYSIS

by Eugene Sefanov

Oracle’s Life Sciences Data Hub (LSH) is a framework that allows sponsors and clinical research organizations to manage clinical trial research data.

One of the most difficult tasks in clinical research is the ability to rapidly bring together and analyze all the relevant data from multiple clinical trials for specific patient subpopulations. This information can be used for many business objectives including monitoring safety risks, planning future trials, and product defense.

Join BioPharm Systems’ Michael Grossman, vice president of clinical data warehousing and analytics, for a free one-hour session on an application within LSH that allows users to dynamically select patient subpopulations and automatically deliver the longitudinal data for those subpopulations for detailed analysis.

You will learn how LSH can:

• Provide dynamic selection of patient subpopulations and automatically generate a longitudinal data mart of the selected subpopulation
• Save and reuse analysis methods and results for future analysis and exploration

View a recording of the webinar at https://cc.readytalk.com/r/691hb42arsm.

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