EDC in Device Clinical Trials - Challenges and techniques in Electronic Data Capture

Why should you take this eConference?
To be in a better position to plan for success in your upcoming EDC trials and address EDC challenges that you may already be experiencing.

Objective:
Although EDC trials are now common place in the pharmaceutical industry, uptake in the device industry has been much slower. Device EDC clinical trials have a set of unique challenges that are rarely addressed in the pharmaceutical dominated marketplace. In addition, the experience of primary investigators in an EDC clinical trial is very important. Frequently, investigators selected for the clinical trials are also the sponsor’s best customers and champions. Having a good experience in the EDC trial will reinforce the investigators’ positive perception of the sponsor’s product and company; having a bad experience may affect product success.

This presentation will review some of the biggest challenges to implementing EDC in device trials. It will focus on device trial related issues and offer solutions or approaches that can be used to address these problems. It will review device specific inventory issues, EDC edits/queries, subject management, monitoring and payment challenges, trial management issues and more. The presentation will also consider the advantages/disadvantages of CRO hosted trials, self-hosted EDC and third-party hosted EDC.

Who should attend:
- Device sponsors who are considering EDC trials
- Device sponsors who are already executing EDC trials - CROs who are considering or executing Device EDC trials
- Clinical Sites that are considering or are involved in EDC trials

You will learn:
What common problems are encountered by device sponsors in clinical trials and how to address, and avoid, these problems. How to determine the best approach for your EDC trial; whether EDC is the correct choice for your trial, whether to host, use a CRO or a third party EDC hosting solution.

You will receive:
- Slides
- An expert speaker
- A chance for Q&A
- CEUs & Certificate

Presenter:
Clinical Device Group is proud to present Mr. Mark C. Jones. Mr. Jones is president of Fortress Medical Systems, developer of Clindex - the leading clinical data management, trial management and EDC solution specifically designed for device clinical trials. Mr. Jones is an industry veteran in both mainstream and clinical information systems. He has been involved in scores of device clinical trials using many different software tools and has setup clinical IT systems for studies as large as 45,000 patients followed for 15 years to 10 patient studies with data collected over a week. Mr. Jones can be reached at mjones@fortressmedical.com 

Comments

[Nancy J Stark]

Hi Jennifer, The recorded eConference is available OnDemand at https://www.clinicaldevice.com/mall/eConferences.aspx.

Or send me an email at njstark@clinicaldevice.com if you have questions.

Nancy