NewswireToday - /newswire/ -
Philadelphia, PA, United States, 2009/08/13 - ERT, a leading provider of ePRO, centralized ECG and other services to the biopharmaceutical, medical device and related industries, announces its educational pre-conference workshop co-hosted with Healthcare Technology Systems, Inc. (HTS).
As part of the Clinical Trials in CNS conference, this workshop entitled "Assessing Suicidality in Clinical Trials and Addressing the Regulatory Directives" will be held at 1:30 pm - 4:30 pm, Tuesday 24th November 2009, in London, UK.
The latest FDA Regulatory Directive requires that prospective suicidality should be monitored in every phase II - IV study, in every protocol and at every visit across therapeutic areas. Professionals in the relevant industries have to ensure their monitoring is in compliance with the latest rules. This workshop is designed to guide Clinical Directors, Therapy Heads, Medical Directors and Clinical Project Managers through the nuances of these new regulations so that they will be better informed and prepared for future trial planning. In particular, during the workshop, three professionals will present methods to make sure that participants' safety monitoring meets the standards and assessments needed in all clinical studies.
Through the workshop, participants will learn what the directive for prospective suicidality monitoring entails, the latest regulatory updates and what experts have already learned about monitoring patient behavior in this area. In addition, they will have a chance to gain knowledge of how to address these new regulatory requirements and how to evaluate the right approach for trials.
The guest expert speakers include Alan Gelenberg, MD, President and CEO of Healthcare Technology Systems, Inc., who is a Clinical Professor of Psychiatry at the University of Wisconsin School of Medicine and Public Health and Editor-in-Chief of the Journal of Clinical Psychiatry; Michael Federico, Vice President ePRO Solutions, ERT and Peter Bennett, Product Specialist, ePRO Solutions, ERT.
Michael Federico, ERT, comments: "We are pleased to announce this first-of-its-kind educational workshop, in partnership with HTS. Suicidality monitoring within clinical trials is a major new advancement and we are delighted to bring together healthcare professionals to ensure that safety monitoring is being adequately met."
In addition, in conjunction with R&D Directions, ERT will be hosting a webinar on September 17 2009 titled: Investigator Site Solutions for Clinical Trials. The hour long event will examine data solutions that investigators can use to gather, monitor and disseminate data from clinical trials, from the site level on up through the sponsor. ERT will examine a practical monitoring and alerting system for tracking suicidality in clinical trials through computerized automation.
For further press information please contact Fiona Robinson, The Scott Partnership, 1 Whiteside, Station Road, Holmes Chapel, Cheshire CW4 8AA, United Kingdom. P: +44 1477 539539, F: +44 1477 539540, E: ert[.]scottpr.co.uk.
About ERT (eResearchTechnology, Inc.)
Based in Philadelphia, PA ERT (ert.com) is a provider of technology and services to the global biopharmaceutical and medical device industries. The Company is a market leader in providing centralized core-diagnostic electrocardiographic (ECG) technology and services to evaluate cardiac safety in clinical development. The Company also provides technology and services to streamline the clinical trials process by enabling its customers to automate the collection, analysis and distribution of clinical data in all phases of clinical development.tatements included in this release may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements, including, but not limited to, 2009 financial guidance, involve a number of risks and uncertainties such as the Company's ability to obtain new contracts and accurately estimate net revenues due to uncertain regulatory guidance, variability in size, scope and duration of projects, and internal issues at the sponsoring client, integration of acquisitions, competitive factors, technological development, and market demand. As a result, actual results may differ materially from any financial outlooks stated herein. Further information on potential factors that could affect the Company's financial results can be found in the Company's Reports on Form 10-K and 10-Q filed with the Securities and Exchange Commission. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.