Siebel Clinical is well-known as a robust clinical trial management system (CTMS) that streamlines clinical trial management. The system can be operated uniquely by users in various roles at sponsor and clinical research organizations.
So in your current position, how would you use Siebel Clinical?

Join BioPharm Systems' Param Singh, vice president of clinical trial management solutions, for this free one-hour webinar that explores how Siebel Clinical can be used by the following six most common clinical trial management job functions:

Clinical Administrator
Clinical Document Associate
Clinical Finance
Clinical Research Associate / Monitor
Executive
Study Manager

Thursday, September 22, 2011 @:

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Oracle Clinical (OC) / Remote Data Capture (RDC) 4.6 provides the ability to conduct global clinical trials more efficiently and effectively. The newest release features significant enhancements that enable and support complex study design scenarios.
Increasing the efficiency of clinical trials, the application enables sponsors and CROs to dynamically drive patient visits and assessment schedules based on subject data and clinical outcomes, increasing the productivity and the effectiveness of a clinical trial.

Join BioPharm Systems’ principal consultant, Mari Clovis, for this free one-hour webinar to examine the new flexible study design features in the latest version of OC/RDC.

This webinar will include both a discussion and demonstration of OC/RDC product features.

Thursday, August 25, 2011 @:

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Trying to build a business case for a clinical trial management system (CTMS) at your organization? Let us help you! BioPharm Systems’ Clinical Trial Management Solutions practice has decades of experience with CTMS implementations for organizations of all sizes. Over the years, our clients have told us the ways in which having a CTMS has benefited them, and we would like to pass the top ten on to you.
Join BioPharm Systems' Param Singh, vice president of clinical trial management solutions, for this free one-hour webinar in which he breaks down each of the top ten reasons why it makes sense for organizations to invest in a CTMS.

A live demonstration of the two most popular reasons and corresponding features (voted on by attendees during webinar) will be performed.

Tuesday, August 23, 2011 @:

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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

Wednesday, June 22, 2011 @

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Date: Tuesday, May 17, 2011
Time: 3pm BST
Length: One Hour (including Q&A session)

According to various research studies of pharmaceutical quality control professionals, nearly half of micro QC organizations continue to operate using manual processes. Time consuming, manual tasks result in slower throughput of samples and longer quarantine times, placing a burden on the Micro QC department who must perform low value, manual tasks.

New technologies have become available to create a more efficient and effective Micro QC Lab, but companies have been slow to adopt. Concerns on how to create a business case for the new technology create one stumbling block. During this free webinar, learn from industry experts the steps to justify an investment in new technology.

During this webinar, you will learn:

* Benefits to automating Micro QC processes
* Technologies available
* Steps to build a business case
* Areas of value to include

Presenters:

* Christof Hasse, PhD, European Business Director, Rapid Micro Biosystems
* Katrien Vanhonacker, Sr. Field Application Specialist, Life Technologies
* Dr. David Jones, Director of Technical Services, Rapid Micro Biosystems

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.

Thursday, June 9, 2011 @

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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?

Thursday, April 21, 2011 @

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Site visit and clinical trip reports are part of every clinical trial. In the past few decades, several tools have been developed to streamline the trip report process. And yet, organizations have shied away from using these tools to their full potential because they are uncertain how to interpret 21 CFR Part 11 as it pertains to electronic signatures.

Join BioPharm Systems' Param Singh, vice president of clinical trial management solutions, for this one-hour presentation in which he will demonstrate how site visit SOPs can be translated into electronic trip report templates in Siebel Clinical, and then completed, reviewed, and approved – entirely electronically.

This webinar will include a live demonstration of the trip report functionality in BioPharm’s pre-configured and enhanced version of Oracle’s Siebel Clinical called ASCEND.

Thursday, June 23, 2011 @

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Pharmaceutical and medical device companies' financial relationships with physicians are a large and growing focus of OIG and DOJ enforcement activity. That makes it more important than ever to ensure that these arrangements can withstand critical examination. Determining fair market value (FMV) fees is difficult, and little practical guidance is available. Old ways of valuing professional services -- surveys of historical data, opportunity cost, etc. -- are no longer good enough. Finding a defensible way to value the specialized services physicians provide as speakers, advisory board members, clinical researchers, etc. is central -- but not the whole answer to the FMV challenge.

Compliance questions typically start with defensible methodology, but increasingly focus on consistency of practice across business and functional groups, ensuring transparency, and the broader framework for handling consultative relationships with providers.

This webinar will provide guidance on how to structure defensible fee determinations, and how to ensure that your broader FMV framework can stand up to the heightened scrutiny that is part of today's compliance environment. Key topics will include:
■Key compliance risk issues surrounding FMV determinations
■What the guidance says that is useful
■Criteria for a defensible FMV methodology
■Critical elements of a broader commercial relationship management framework
The session will provide you with the latest insight on mitigating FMV risk, and a concise approach for evaluating your current framework. Wherever you are on the FMV learning curve, this session will leave you clearer about what you’ve got in place, and what you might need to prepare for OIG’s evolving expectations.

The one-hour session will include a 35-40 minute discussion and review of critical FMV issues, and 20-25 minutes for Q&A.

Presenter

Stephen Rothenberg, J.D., Numerof & Associates, Inc.

Mr. Rothenberg has extensive experience assisting clients across functional areas in the pharmaceutical and medical device industries. He’s supported compliance functions in auditing and monitoring, risk assessment, and development and implementation of fair market value determination processes. His legal experience positions him to effectively identify emergent compliance trends and enforcement priorities as guidance to clients. He received his law degree from Washington University in St. Louis.

Who Should Attend

Executive leaders who are increasingly being held accountable by OIG for compliance gaps, and all staff concerned with ensuring regulatory compliance in the pharmaceutical, medical device, diagnostics, and biologics sectors.

Time: 14:15 GMT

For years Electronic Batch Recording (EBR) systems tried to mimic paper based batch records. Rockwell Automation broke with the old ‘Paper- On-Glass’ paradigm to help maximise productivity of every user at every step of the lifecycle from recipe design to execution, review and approval.

The webinar will explore a new way to implementing MES in the pharmaceutical industry with a case study from F. Hoffmann - La Roche AG

Learn how F. Hoffmann - La Roche AG successfully implemented a new MES in their pharmaceutical drug substance production. Mr. Robert Fretz, Head of Process Automation and MES, will talk about the benefits of a new MES solution, especially, an innovative integration scenario within the heterogeneous DCS landscape.

Additionally Martin Dittmer, Product Manager at Rockwell Automation will explain major MES concepts, and give a live demonstration with the system, giving an insight into excellent usability and look and feel.

This webinar will help you to

•Understand how to minimise time and cost for MES integration

•Understand how to increase 'right first time' on the shop floor

•Understand how to create master recipes faster

Intended audience: CEO’s, CIO’s, plant directors, quality directors, production directors and compliance officers in drug manufacturing, biotech, and API sectors of the pharma industry

Technical Requirements
- PC headset
- PC speakers
- Broadband Connection