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.

OPEN UI: THE NEW FACE OF SIEBEL CTMS

by Eugene Sefanov

Oracle recently unveiled a new version of Siebel Clinical, a highly-sophisticated clinical trial management system (CTMS) used by life sciences companies, big and small. The latest major release, frequently referred to as Open UI or 8.1.1.11, provides users and administrators with more freedom and flexibility than ever before.

Join us for a free one-hour webinar in which BioPharm’s Param Singh, vice president of clinical trial management solutions, will review the new enhancements that have been introduced in the CTMS.

After the presentation, attendees will have a better understanding of the:

— Features and benefits of Open UI

— Open UI implementation process

— Open UI upgrade considerations and process

In addition to looking at the new capabilities, a brief demonstration of Open UI will be provided.

Register to view the webinar: https://cc.readytalk.com/r/dhrk6p49ih1e&eom

For more information about BioPharm Systems, 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.

CLOUD-BASED VS ON-SITE CTMS: WHICH IS RIGHT FOR YOUR ORGANIZATION

by Eugene Sefanov

More and more sponsors and clinical research organizations (CROs) are moving their clinical applications to the cloud, seeking faster implementation timelines and reduced maintenance costs. Nonetheless, some organizations are hesitant to make the move because they are not sure how to navigate the risks and benefits of having a third party manage their servers and applications in remote data centers.

In this free one-hour educational webinar, Param Singh, vice president of clinical trial management solutions, BioPharm Systems, will share the pros, cons, and risks that organizations should consider when deciding whether to host their clinical trial management system (CTMS) in the cloud. He will be joined by special guest, Sally Sweeney, director of validation, BioPharm Systems, to discuss the validation implications of hosting clinical systems.

Register to view the webinar: https://cc.readytalk.com/r/g8yqq3tcncvs

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

CLINICAL TRIAL SUPPLY MANAGEMENT WITH SIEBEL CTMS

by Eugene Sefanov

Clinical supply and inventory management is a crucial part of the clinical trials process. Tracking investigational product and ancillary supply shipments to a site – including quantities, lot numbers, and dates – can help sponsors and clinical research organizations (CROs) save money and prevent headaches.

Wouldn’t it be nice if all the tracking could be done within a clinical trial management system (CTMS)? Well, we have good news: with Oracle’s Siebel CTMS, it can.

Clinical supplies can be tracked in Siebel Clinical right out-of-the-box. However, simple extensions, such as adding fields to an existing screen, and more complex enhancements, like adding new screens or an entire clinical supply management module, can make the tracking process more efficient, useful, and compliant.

Join BioPharm Systems’ Param Singh, vice president of clinical trial management solutions, for this complimentary 60-minute webinar in which he will:

• Discuss the struggles associated with clinical supply management and offer potential solutions
• Outline ways to use Siebel Clinical to track clinical supply inventory levels with and without system modifications
• Demonstrate how companies are currently tracking clinical supply and inventory with Siebel Clinical

Register to view the webinar at https://cc.readytalk.com/r/nzfcucjgo4gn.

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

USING IHELP TO HELP USERS HELP THEMSELVES IN SIEBEL CLINICAL

by Eugene Sefanov

Have you ever found yourself stuck on a task in Siebel Clinical, Oracle’s Clinical Trial Management System (CTMS)? Or, have your organization’s users ever complained about forgetting how to perform a task? Although you may already have a comprehensive user guide, it’s probably quite lengthy (perhaps over 300 pages!) and cumbersome to use. Wouldn’t it be nice if Siebel Clinical had a guide built right into the application that could provide step-by-step instructions and tips exactly when and where you need them? Enter iHelp.

iHelp is an interactive and context-sensitive user documentation system that comes with Siebel Clinical. That’s right – if you have Siebel Clinical, you already have iHelp. From quick pointers to full sets of instructions, iHelp can guide you through the steps in real-time. The level of detail is entirely up to you – each organization has the power to create iHelp content that is 100% relevant to their users’ needs. No more getting stuck!

Join BioPharm System’s Param Singh, vice president of clinical trial management solutions, and Richard Gavan, CTMS consultant, for this free one-hour webinar and demonstration in which they will:

• Provide a general overview of iHelp
• Discuss ways companies like yours are currently using the feature
• Share useful methods of deploying iHelp content
• Explain the basics of iHelp administration and development

Training one or two users to develop content in iHelp could help the rest of your users become experts in Siebel Clinical, minimizing your need for refresher training, reference materials, and user support. Register to learn more!

Register to view the webinar at https://cc.readytalk.com/r/k5zuw3g6ybuy.

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

FREE WEBINAR: EXPLORING METRICS IN SIEBEL CLINICAL

by Eugene Sefanov

Siebel Clinical is a clinical trial management system (CTMS) known for its robust ability to track trial information, but we can still struggle from time to time when it comes to understanding what key metrics are available in the system, and how to get them out of it.

Join BioPharm Systems’ Param Singh, vice president of clinical trial management solutions, for this free one-hour webinar in which he will answer the following questions about Siebel CTMS and metrics:

• What categories of metrics are available in Siebel Clinical?
• What metrics are available within those categories?
• What additional metrics are available in Siebel Clinical via simple data manipulation, system configuration, and add-on tools and modules?
• How do you apply these metrics in clinical operations and trial management?

Register to view the webinar at https://cc.readytalk.com/r/59mdfrkzs573.

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

FREE WEBINAR: STRATEGIES FOR CONTINUOUS CTMS IMPROVEMENT

by Eugene Sefanov

Whether you are an organization who had just implemented a clinical trial management system (CTMS) or an organization that has had a CTMS for a while, it is always a challenge to plan a short-term and long-term CTMS roadmap that meets the expectations of end-users.

Join BioPharm Systems’ Param Singh, vice president of clinical trial management solutions, for this free one-hour webinar that will address the following questions that a sponsor and clinical research organization (CRO) should consider when developing a CTMS continuous improvement plan:

• Who should be involved, as a stakeholder, in the development of a roadmap?
• How frequent should the change control board meet?
• What is the scope of the continuous improvement plan?
• Where should you gather input for the continuous improvement plan?
• What information should be captured for system enhancements?
• How should you prioritize future system enhancements?

Register to view the webinar at https://cc.readytalk.com/r/1kvs167zocox.

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

FREE WEBINAR: MAKING THE MOVE TO AN ENTERPRISE CTMS FOR ORGANIZATIONS OF ANY SIZE

by Eugene Sefanov

How does a sponsor or clinical research organization (CRO) know when it is time for a comprehensive clinical trial management system (CTMS)? How does an organization prepare for the change and choose the right system?

Join BioPharm Systems’ Param Singh, vice president of clinical trial management solutions, for this free one-hour session in which he will:

• Shed light on the key indicators that point to the need for an enterprise CTMS
• Take a deep dive into the internal analysis necessary for identifying process changes and system requirements
• Explain how to get different stakeholders on board and excited
• Provide guidance on an effective vendor selection process

Register to view the webinar at https://cc.readytalk.com/r/4intzssh2037.

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