ClinPhone Conducts Educational Webinar on New FDA Guidelines
ClinPhone Conducts Educational Webinar on New FDA Guidelines
(September 22, 2006) ClinPhone, the global leader in clinical technology solutions, is conducting two educational webinars to address the impact of the Food and Drug Administration’s (FDA) draft guidance on Patient Reported Outcomes (PRO). The webinars, which are scheduled for 4th and 5th October 2006, will explore the key components proposed in the draft guidance and compare it to existing European guidelines. These sessions will also discuss how to pragmatically approach PRO use in the context of clinical development programs. Registration for this event is free and can be obtained through the company’s website www.clinphone.com/webinars
The FDA’s new draft guidelines on Patient Reported Outcomes have stimulated a great deal of discussion in the biopharmaceutical industry. For the first time, the guidance documents the regulatory perspective on the use of PRO, delivered on paper or electronically. As a result, many sponsors are actively seeking practical ways to satisfy the new requirements.
In response to this growing industry need, ClinPhone is providing biopharmaceutical professionals with the opportunity to learn more about the guidelines and their potential impact through educational webinars. These webinars will detail the relevant areas of the guidelines and answer a number of questions including:
What are the key requirements of the guidance with respect to ePRO?
When must I prove the validity of the ePRO instruments I am using?
What alternatives are available for ePRO validation?
Keith Wenzel, ePRO Product Director at ClinPhone, comments: “The biopharmaceutical industry’s move to the paperless collection of PROs in clinical trials has been growing steadily. At the same time, there has been uncertainty due to the lack of formal regulatory guidance. With the FDA’s proposed guidance, we now have insight into the FDA’s thinking with respect to PRO data for labelling claims. ClinPhone is offering these free webinars to help explain the ePRO considerations and pragmatic steps in the context of the draft guidance.”
ClinPhone works with many of the world’s leading pharmaceutical and biotechnology companies to provide a wide range of eClinical Solutions. The
company is the largest and most accomplished Clinical Technology Organization (CTO) in the industry, with experience in over 1,700 trials.
For further information on ClinPhone’s upcoming webinar schedule, please visit www.clinphone.com, or alternatively email info@clinphone.com
About ClinPhone
ClinPhone Group Ltd is a specialist Clinical Technology Organization (CTO) working with the leading global biotech and pharmaceutical organizations. With its corporate headquarters in Nottingham, UK, ClinPhone is the largest and most accomplished CTO with experience in over 1700 clinical trials spanning 88 countries and 71 languages.The company’s solutions enable its clients to manage their clinical trials more effectively through the use of technology. Building on its telephone and web-based randomization and medication management expertise, ClinPhone can offer a wide range of innovative products covering all aspects of a clinical trial, including Electronic Patient Reported Outcomes (ePRO), Interactive Voice and Web Response (IVR and IWR), Patient Recruitment Solutions, and Clinical Trial Management Software (CTMS).
