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Agile Computing Authors: Pavan Kumar, Darren Anstee, Elizabeth White, Liz McMillan, Pat Romanski

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Regulatory Topics Highlight PHT Corporation’s U.S. PRO & eCOA Congress

The benefits of PRO (Patient Reported Outcomes) and eCOA (Electronic Clinical Outcome Assessment) Systems in advancing regulatory approval of clinical trial programs are the focus of 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.

Representatives from more than 25 pharmaceutical companies including many from the world’s top 20 will attend the most educational PRO event of its kind. Clinical operations, data management, regulatory, outsourcing, research site and health outcomes professionals will participate and present at the meeting, along with PHT PRO and eCOA thought leaders.

Participants will learn how to become internal team leaders to help assess PRO data needs, expedite study setup times, reduce the time required to monitor and analyze data and structure future PRO and eCOA programs. They also will gain insight into how clinical, data management, regulatory and outsourcing functional groups work together with PRO data.

Agenda Advances PRO & eCOA Knowledge and Deployment

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.

Representatives from FDA are scheduled to speak on requirements for the compliant use of ePRO and other eCOA instruments to support FDA submissions. Congress attendees will also benefit from a 60-minute Q&A forum to ask the FDA about specific dossier and submission issues.

Confirmed speakers represent organizations including Janssen PRD, Shire, Eli Lilly, Sanofi-Aventis, Ironwood, Novo Nordisk, and Hospice of the Bluegrass.

Topics include:

  • The 6 modalities for collecting PRO data, and which method is best for a study
  • Best practices, implementation strategies and operational insights
  • Innovative ways sponsors are using ePRO in their trials
  • New trends in patient-based eClinical integrations and technologies

100% Positive Feedback from Past Participants

All 2012 Congress attendees said they would recommend the event to a colleague and rated the content as very valuable. 98% said they could justify the Congress based solely on the benefits of networking with other companies involved with eCOA/ePRO Systems. Watch short videos of satisfied participants at the 2012 PRO & eCOA Congress: http://goo.gl/CWBsl

Sheila Rocchio, PHT Vice President of Marketing and Product Management, said, “PHT is committed to helping researchers do great science that improves patient quality of life. The PRO & eCOA Congress event and alumni community supports this goal through providing relevant and meaningful education and networking for every attendee. Delegates leave with new expertise in the science, technologies and regulatory requirements of PRO and eCOA Systems.”

Space is limited. Register today for the 2013 Baltimore PRO & eCOA Congress at http://www.bit.ly/PbKR6Z

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 www.phtcorp.com for more information on PHT. Follow PHT on LinkedIn, Twitter and YouTube.

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