EDC Rescue Studies & Clinical Data Migrations – Challenges, Business Justification, and Approach

During this webinar, OmniComm Transformation Services will explore the challenges, business justification, and approach to EDC Rescue Studies and Clinical Data Migration where you will learn:

• Why an organization would consider migrating an ongoing clinical study
• How a proper migration plan can reduce the challenges faced during such a complex project
• How migrations can be cost-effective solutions in the long run
• How to mitigate concerns such as validation and process alterations

Factors such as ongoing industry consolidation, continual regulatory change, rapid technology evolution, and unending cost cutting are causing organizations to consider replacing or upgrading their existing Electronic Data Capture (EDC) solution.

The value proposition to migrate is fully justified if your organization can achieve the following business benefits:

• Lower the overall cost of delivering electronic clinical trials – fully dependent on the number of trials, the type of trials, your timelines, and your organizational capabilities.
• Reduce Regulatory Risk and Data Quality Concerns – this requires clinical data migration to technology that is validated, compliant with 21 CFR Part 11, Safe Harbor certified, and hosted in a HIPAA/SAS70 Type II compliant data center.
• Leverage Best Practices and Industry Standards – wherever possible, we recommend that you embrace the use of industry standards to provide economies that enable data portability, increased quality, and reduced cycle times. And you must ensure that existing business processes, SOPs, training materials, or data standards are retained and leveraged wherever feasible.

The roadmap for migrating from one application to another does not have to be so overwhelming, if you bring knowledge, experience, and methodology to the project.

During this seminar OmniComm representatives will review:

• The value proposition for migrating a clinical study
• A logical methodology for both business process migration, and physical study migration
• How to minimize risk and how to manage change
• Next steps, if you are considering a migration

Speakers

Ken Light, EVP of Transformation and Professional Services, OmniComm Systems, Inc.

Ken Light is EVP of Transformation and Professional Services at OmniComm Systems, where he oversees projects to support technology transfer, integration, training, migration and business process improvement for the global Life Sciences community.

Prior to joining OmniComm Systems, Ken oversaw similar clinical strategy and technology consulting practices for Oracle Corporation, BusinessEdge Solutions, and First Consulting Group. For the past twenty years, Ken has delivered technology and business strategy services to the majority of top twenty Pharmaceutical manufacturers, along with many smaller health and life sciences organizations. Mr. Light has an M.S. in Computer Science from Fairleigh Dickinson University, and a B.S degree from the State University of New York at Binghamton.

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Rob Mangold, Sr. Director of Client Services, OmniComm Systems, Inc.

Rob Mangold is Sr. Director of Client Services at OmniComm Systems, where he leads implementation projects and manages customer relationships revolving around OmniComm’s core EDC products. Prior to joining OmniComm Systems, Rob delivered EDC solutions in a consultant role for ERT. Providing advisory consulting, training, system design, analysis, management, and general assistance, Rob has 15 years of experience with various EDC technologies in all sectors of the Life Sciences industry. Rob has a B.S degree in Electrical Engineering from the Pennsylvania State University

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