Regulatory Considerations

A major contributing factor of ePRO's increasing adoption has been encouragement from the FDA (e.g. PRO Draft Guidance), the EMEA and other regulatory authorities who appreciate the high quality data that ePRO systems provide. PHT is the only handheld provider to achieve and maintain ISO certification of its quality management system, thereby providing sponsors with peace of mind about technical validation and regulatory compliance.

FDA Submissions and Approvals

Endpoint data collected firsthand by PHT's ePRO systems have been successfully used by our clients in a series of NDA submissions and drug approvals (review our current experience). Most importantly, there has never been an issue raised during FDA audits of sites using PHT's ePRO System

Sites in Control

PHT's technically validated system ensures that control of the eSource data remains with investigator sites at all times in compliance with regulations established by 21 CFR 312.62. Sites have on-demand access to the data by logging into StudyWorks, which features varying levels of permissions and privileges for acting on electronic records (21 CRF 11). For years, PHT has been providing each site with a letter explaining how they will prepare, maintain and retain eSource data throughout the duration of the trial and beyond.

Study Archive

PHT's Study Archive is delivered to sponsors and sites upon trial close-out. The archive uniquely uses XML source and metadata in order to meet regulations for trial reconstruction and retention periods. Our expert Study Support Center instructs sites on how to use the archive to prepare for an FDA site audit.

Learn More about ePRO Regulatory Requirements

How can I review more detailed information on PHT's regulatory conformance? How many audits has PHT undergone? What is the actual source data - is the LogPad or StudyWorks considered source? Contact PHT for answers to these questions or any others you may have.