Preparing for ePRO Regulatory Inspections

Audit Photo Clinical trial sponsors go to great efforts when preparing for regulatory audits as they seek approval of new biopharmaceuticals and medical devices. Sponsors who have captured PRO data electronically should be equally prepared to respond to inspectors’ inquiries regarding ePRO data collected during clinical trials.

invivodata has supported numerous sponsors through ePRO regulatory inspections in the US, EU, and Japan, which have lead to numerous successful market approvals. Through our experiences, we have witnessed some common themes and collaborated with sponsors on responses that meet regulators’ expectations. Here, we provide the following resources to help sponsors address the challenge of an ePRO inspection from a regulatory agency.

CONFERENCE SERIES: Meet with international experts and hear case studies of successful ePRO regulatory inspections at PROficiency™ 2012: PROs and Beyond, inviodata’s 5^th annual conference.

PUBLISHED ARTICLE: “Real-Time Patient Reporting Could Open The Door To FDA Inspection”. Dubin, C., Life Science Leader, February 2011. invivodata’s successful DiaryPRO and SitePRO study with Sucampo is highlighted in the February issue of Life Science Leader. In this article by Cindy Dubin, invivodata’s Gretchen Craig and Sucampo’s Dr. Raymond Panas discuss ePRO and the FDA inspections that resulted in the approval of Sucampo’s drug, Amitiza.

WHITE PAPER: Read “ePRO Regulatory Inspections: Best Practices for Smooth and Successful Outcomes“, Craig, G., September 2010. In this White Paper, members of invivodata’s ePRO Inspection Team review our experiences in supporting and participating in ePRO regulatory inspections around the globe, and outline best practices for ensuring smooth regulatory inspections of ePRO data collection systems.

WEBINAR: Download webinar replay: “ePRO Regulatory Inspection Expectations – Be ready, be agile, be precise!“ (original date: June 24, 2010). Based on real-world ePRO experiences with regulatory inspectors, this webinar identifies the inspectors’ key areas of interest during an ePRO inspection and highlights a case study of an inspection along with recommendations on preparing for and supporting site and system inspections.