As more and more studies are set up in an EDC system for electronic data capture, all needed subjects and related serious adverse event (SAE) data are available electronically as soon as they are entered in EDC. Conventional methods of SAE data transfer and reconciliation are time consuming and resource intensive processes. Therefore, organizations have opportunities to move to a more streamlined process to the benefit of both site and sponsor users.

An option to transfer data electronically to the Pharmacovigilance group is now possible; where data are constantly extracted from the EDC system, transformed into E2B format and imported to a Pharmacovigilance database.

Hear from industry experts how to implement an automated process for EDC to PV via E2B.

Keywords:

Speakers

Rich Davies, Executive Director of Business Solutions, OmniComm Systems, Inc.

Richard joined OmniComm in February 2014 and is based in the UK. As Executive Director of Business Solutions his role is to support organizations’ adopting OmniComm solutions from a technical, functional and business process perspective, particularly as they execute their vendor selection programs. Additionally he has product management responsibilities and provides a bridge between customers, prospects and ongoing product development. Prior to joining OmniComm he held multiple roles in the sales and implementation of many types of e-clinical, drug safety, warehousing and healthcare technologies. He has worked for technology vendors for nearly 20 years but started his career working in data management with Fisons Pharmaceuticals and Astra.

Mr. Davies earned his Bachelor of Science degree in Computer Science from DeMontfort University in the UK.

Message Presenter

Dr. Marc Zittartz, Chief Quality Officer, pharmasol

Dr. Marc Zittartz joined pharmasol in 2013 as Chief Quality Officer and member of the executive management team to develop and implement pharmasol’s strategy to deliver innovative software solutions, GxP compliant cloud hosting and expert consulting service for the life science industry. Dr. Zittartz has more than 10 years of experience in the life science industry in both Europe and USA. In his previous roles he successfully managed all aspects of GxP relevant IT applications in the areas of Regulatory Affairs, Clinical Development, and Pharmacovigilance. Dr. Zittartz holds a PhD. in physics from the University of Cologne, Germany. Throughout his career he has been a consistent contributor to the advancement of R&D IT solutions through several networks such as OHSUG and DIA.

Message Presenter

Who Should Attend?

Heads of Clinical Data Management
Heads of Clinical Innovation
Heads of Clinical IT
Heads of Clinical Operations
Heads of Clinical Research
Heads of Clinical Systems
Heads of Medical Affairs

Xtalks Partners

OmniComm Systems

OmniComm Systems is a leading strategic software solutions provider to the life sciences industry. OmniComm Systems is dedicated to helping the world’s Pharmaceutical, biotechnology, CROs, research and medical device organizations maximize the value of their clinical research investments. Through the use of innovative and progressive technologies these organization drive efficiency in clinical development, better manage their risks, ensure regulatory compliance and manage their clinical operations performance. OmniComm provides comprehensive eClincal solutions from Phase I through late phase clinical trials with an extensive experience with over 4,000 clinical trials.

Pharmasol

pharmasol is a leading provider of innovative applications, GxP compliant hosting and implementation services to the life sciences industry. With tools to automate complex business processes and the option to host applications in a secure managed data centre, pharmasol is trusted by leading Pharmaceutical, medical device and contract research companies to optimize workflows and ensure compliance.