The Importance of Quality in the Informed Consent Process

For decades, issues with paper-based consent have been the source of the most common and most significant violations raised by Global Health Authority inspectors. In 2019 alone, more than 1/3 of all issued US Food and Drug Administration (FDA) Form 483s were related to informed consent findings, while the European Medicines Agency (EMA) reported that consent issues represented the 4th highest cause of critical inspection findings and the 5th highest cause of all site inspection findings.

These errors are costly, time-consuming and can jeopardize the completion of a trial. And these issues cannot be remediated with the continued use of paper-based consent, as they stem from the physical properties of paper itself.

That is why more and more sponsors have switched from paper consent to eConsent. But making this change must be more than just digitizing paper consent forms, the need for a complete informed consent process that better educates and retains patients while minimizing errors is key.

Join this webinar as industry experts identify the most common issues with the paper-based consent process, and what to look for in a complete consent management solution in order to reduce quality issues while improving oversight.

Speakers

Andrew Mackinnon, Vice President & General Manager, Consent Management, Medable

As General Manager for Consent Management, Andrew Mackinnon oversees the development of Medable’s Total Consent solution, as well as the implementation of eConsent in Medable studies, ensuring that Medable’s clients can run high quality, effective and efficient patient-first decentralized clinical trials. Andrew has 20 years of experience in managing clinical trials at large pharma, biotech and CRO companies, most recently as a Senior Director in one of Covance’s therapeutic area delivery groups and as Head of Business Performance. From his involvement in one of the earliest deployments of decentralized methodologies, he has been passionate about the benefits that this approach can bring in reducing the burden of clinical research on both sites and patients and looks to leverage his broad operational expertise to improve how this approach is utilized.

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Shyanne Ali, Founder, Clinical Quality Associates LLC and Vice President, Quality Assurance, Aditum Bio

Shyanne Ali has over 20 years of pharmaceutical drug development experience in the areas of Global Clinical Operations, Global Clinical Development, and Quality Assurance. Over the course of her career, Shyanne has led Global R&D Quality organization at Boehringer Ingelheim, Intercept Pharma and tech start-up, TrialSpark. Prior to her leadership roles in Quality Assurance, she held leadership roles in global clinical operations functions at Abbott Laboratories, Novartis Oncology and Novartis Vaccines.

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