Data privacy is a hot topic for the drug industry at the moment, especially for contract research organisations (CRO) which are required to balance sponsors demands for rapid data access with the need to maintain the rights of trial participants.
Part of the challenge of trial data management comes from the number of regulatory agencies worldwide that govern clinical research, with privacy standards differing from one region to another.
And, for a specialist like Phase Forward the issue of privacy and regulatory compliance is considerable given the number of global multicentre trials that rely on the firm’s range of electronic data capture (EDC) and trial management solutions.
Michael Owings, Phase Forward’s VP of quality and compliance since 2004, will step into the new role and make sure that all the firm’s privacy and data protection policies comply with relevant regulations.
Owings told Outsourcing-pharma that: “Customers and partners must balance the desire for transparency, urgency and mitigation of risk in reporting trial results and safety data against the regulatory imperative to ensure privacy of patient data.
He went on to explain that: “[Pharmaceutical firm’s] conducting global trials face an increasingly complex regulatory environment and that it requires a multi-threaded approach to monitor all the relevant regulations.
“Since we have customers conducting trials in more than 100 countries, we likewise must be vigilant with global regulations as data protection concerns and privacy regulations continue to grow worldwide.
“Staying on top of current regulations across multiple geographies is a significant challenge. Phase Forward feels the appointment of a chief privacy officer will support our customers in this challenge and provide an expert resource regarding the latest standards and policies in this fast-changing area.”
In a press statement, CEO Bob Weiler said that Owings, who has been accredited by the International Association of Privacy Professionals (IAPP), “has been instrumental in building the company's reputation as a leader in regulatory compliance.
"This new role is a natural extension of Michael's in-depth knowledge of compliance issues, and he will help to ensure that our policies and products meet the highest possible standards for processing and storing sensitive data."