ConsentSolutions CEO to Present FX Audio Conference on Making the Decision to Implement Electronic Informed Consent

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Dr Susan Brink, CEO will discuss the benefits of an electronic consent process for sponsors and candidates and the steps to making a decision about electronic consent use for a specific trial.

Dr Susan Brink, CEO will discuss the benefits of an electronic consent process for sponsors and candidates and the steps to making a decision about electronic consent use for a specific trial.

As clinical trials have moved toward electronic methods for patient recruitment, trial management and data collection, the provision of candidate informed consent has remained as a paper-based document that is increasingly outside the trial management process. Increasingly the possibility of using electronic formats to enhance the consenting process is being considered.

Susan Brink, CEO of ConsentSolutions says “many pharmaceutical and device companies, large and small are considering a move to electronic consenting for their trials. Naturally there are many questions about how to get started with this new approach. We are pleased to be able to share our lessons learned with those who are considering this decision.”

This audio conference will explore the benefits to sponsors and candidates and the steps to a decision about electronic consent use within the trial enrollment process, with analysis of organizational needs and goals re informed consent, training and SOPs, considering trial risk management, assessment of FDA guidance re electronic consenting and connections to upstream trial activities, i.e. candidate recruitment, candidate enrollment, multiple languages, candidate illiteracy, e-trial management and data capture facilities. Guidance on the identification of appropriate trials for pilot testing an electronic consent process will be provided.

About Consent Solutions

Founded in 2005 and based in Frederick, Maryland, with offices in Norwich Vermont, ConsentSolutions is focused on adding value to the consenting process through the development of interactive, user-friendly software that help candidates and patients make informed decisions about research participation and sponsors get to market through faster and more effective trial participant enrollment. With decades of combined experience developing educational multimedia applications, our senior management team is dedicated to the goal of shared decision making for trial participation among volunteers, patients, trial staff, investigators, and physicians.

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