ERT, the leading provider of best-in-class technology and services for the successful execution of clinical trials, will be offering a free seminar on effective strategies for early phase clinical trials. The event will be held on March 3 2009, 8:00 am - 1:30 pm, Westin Copley Place, 10 Huntington Avenue, Boston, MA. As part of the company's seminar series "Data to Power Decisions in Early Phase Trials", ERT and its partner AAI Pharma invite interested parties to attend informative talks and engage in active discussion on the latest trends and approaches for utilizing cardiac safety and biomarker data in early phase clinical trials. This seminar is aimed at clinical project managers, therapeutic heads, clinical data mangers, medical directors and pharmacovigilance specialists seeking insights on maximizing their clinical activities and data. Online registration to the seminar is open via the website or by emailing swalder[.]ert.com or calling +1.908.203.6295.
The keynote speaker is industry expert Dr. Jeffrey Litwin, M.D., F.A.C.C., Executive Vice President and Chief Medical Officer at ERT, who will discuss optimized study designs of intense cardiac monitoring in exploratory development clinical pharmacology. Early development stage compounds have limited data available for traditional statistical analysis of cardiac safety. If carefully designed, exploratory studies such as First in Human (FIH) and Single and Multiple Ascending Dose (SAD/MAD) studies can include cardiac monitoring to develop exposure-response models. Quantification of the Pharmacokinetics and Pharmacodynamics (PK/PD) relationship may provide early insight into potential cardiac safety issues in the evaluation of commercialization prospects as well as a decision gate for further development.
John Todd, Vice President, Research & Development at Singulex, will speak about troponin as an early development biomaker for cardiac events. Blood cardiac troponin-I (cTnI) concentration has been validated as a biomarker for cardiotoxicity in numerous animal models and holds promise as a predictor of cardiotoxicity in humans. In his data driven presentation, Todd will discuss the use of cTnI, measured using new generation high sensitivity assays, as a biomarker of cardiac injury in preclinical and early clinical drug development outside the accepted paradigm of QT prolongation.
Finally, Harsh Singh, Vice President at AAI Pharma North American Clinical Operations will speak about the management of complex FIH cardiac intense studies. Focused, excellent project management is the lynchpin to the success of an intense cardiac monitoring clinical pharmacology study from early design discussions through completed integrated clinical study reports. Singh will discuss how to implement a clinical project operations plan to define the scope of work, forecast recruiting and enrollment, accurately predict overall timelines using industry standards and Gantt charting, provide critical path analysis, risk analysis and contingency planning. Additionally industry trends will effectively illustrate the value of clinical project management in leveraging multiple operations and data streams to produce high quality, on time results.
ERT is a leading provider of technology and services to the biopharmaceutical and medical device industries around the world. The recently re-branded company encompasses four key areas: Cardiac Safety Solutions; EDC Solutions; ePRO Solutions and the Clinical Research Consulting Group, all of which are enabled by the company's innovative technology platform - EXPERT.
"Data to Power Decisions in Early Phase Trials" is part of a series of seminars being held over the next four months. For further information about ERT or the seminar series and to register your attendance please email events[.]ert.com, call +1 866 538 2808.
About eResearchTechnology, Inc. (ERT)
Based in Philadelphia, PA, ERT (ert.com) is a provider of technology and services to the biopharmaceutical, medical device industries on a global basis. 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 is also a leader in providing 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.
Statements 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, 2008 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.