Jonathan S. Helfgott, FDA Compliance Officer for Center for Drug Evaluation & Research (CDER), to Address PHT Corporation U.S. PRO & eCOA Congress

Policy and compliance expert to discuss FDA perspective on compliant use of ePRO instruments

BOSTON & GENEVA--()--PHT Corporation announced that Jonathan S. Helfgott, FDA Compliance Officer for CDER, within the office of Scientific Investigations, will present: “FDA Perspective on the Compliant Use of ePRO Instruments to Support FDA Studies” at the 17th PRO & eCOA Congress, March 26-28 in Baltimore, Maryland. The Congress is sponsored by PHT Corporation, the leading provider of innovative technology systems used to collect patient-driven eData for clinical research.

“FDA Perspective on the Compliant Use of ePRO Instruments to Support FDA Studies”

Mr. Helfgott specializes in Computerized Systems used in FDA regulated Clinical Investigations. Prior to joining CDER in 2010, he worked at the Center for Devices and Radiological Health (CDRH) within the Division of Bioresearch Monitoring (BIMO). Mr. Helfgott is also a Lecturer for Johns Hopkins University’s Graduate Program in Bioscience Regulatory Affairs. He is the Co-Editor of the Food and Drug Law Institute’s 2009 Publication, “Biomedical Software Regulation.” Mr. Helfgott has also been published in Peer Reviewed Journals such as Applied Clinical Trials, RAPS Focus, Association of Clinical Research Professionals, FDLI Update, Touch Briefings, and Medical Device and Diagnostic Industry. Mr. Helfgott has also lectured for organizations such as DIA, ACRP, RAPS, SOCRA, SCDM, AdvaMed, CHI, CBI, and FDA News as well as academic institutions such as Northwestern University, Columbia University, Johns Hopkins University, University of Colorado Denver Medical School, University of Pittsburgh Medical Center, Georgetown University, Stanford University School of Medicine, Children’s Hospital of Philadelphia, Shriners Hospitals, and NIH’s National Heart Lung and Blood Institute. Mr. Helfgott co-developed the Software Education Program for the CDRH Staff College through the Medical Device Fellowship Program. Prior to joining FDA in May 2006, Mr. Helfgott conducted genetic research using micro-array technology at the NIH’s National Institute on Aging. Mr. Helfgott received his MS from Johns Hopkins University and his BS in Cell Biology and Molecular Genetics from the University of Maryland College Park.

The PRO & eCOA Congress Agenda features 20 new presentations, case studies, debates and roundtable discussions from professionals actively involved in eClinical research programs. Educational sessions are based on best practices and lessons learned, and provide actionable information attendees can implement at their organizations.

Space is limited. Register today for the 2013 Baltimore PRO & eCOA Congress at

PHT invites all Congress alumni to join the exclusive PRO & eCOA Congress LinkedIn Community to exchange information, ideas and experiences throughout the year.

About PHT Corporation

PHT Corporation helps pharmaceutical companies and CROs conduct clinical trial programs with greater confidence, ease and accuracy. Proven PHT eCOA (electronic Clinical Outcome Assessment) Systems collect patient-driven eData via smartphones, tablets and the web. This data, available via the PHT StudyWorks® online portal, provides sponsors and clinicians with a real time window into how patients feel and function. The service and technology that PHT provides helps clients speed new therapies to market that ultimately improve patient quality of life around the world. PHT has helped trial sponsors collect patient-driven eData in 600+ global trials resulting in 16 regulatory approvals. PHT offers the regulatory, technological, and scientific expertise today’s market demands and patients deserve. Visit for more information on PHT. Follow PHT on LinkedIn, Twitter and YouTube.

Release Summary

Jonathan S. Helfgott, FDA Compliance Officer for CDER within the office of Scientific Investigations will present at the U.S. PRO & eCOA Congress hosted by PHT Corporation, March 26-28, Baltimore.

PHT Corporation