The regulatory landscape has shifted in the wake of COVID-19. Regulatory bodies have made concessions and released guidance in an effort to allow clinical trials to continue and also to get COVID studies up and running in record time. At the same time, the European Union (EU) has issued major judgments on Privacy and HIPAA that will also affect the industry long-term.
In this webinar, we will take a deep dive into how the regulatory changes made as a result of COVID-19 have and will continue to impact data management of clinical trials across the globe. We’ll also discuss what the future holds with regard to the recent EU rulings. Plus, we’ll share some tips for staying abreast of the rapid changes so you can quickly adapt and keep trials running because we all know patients can’t afford to wait.
Clinical Data Architect, SK Data Consulting Pty, Ltd.
Simone Knab is a Clinical Data Architect at SK Data Consulting Pty Ltd. in Perth Western Australia. She has over 15 years of experience working with and validating Clinical EDC platforms and databases. Leading extensive, first-time eSource development, validation, and training for top 5 Pharma organizations and large investigator sites, Simone was responsible for successfully implementing eSource (Medrio DDC, ePRO and EDC) at Linear Clinical Research.
Sr. Director of Quality Management, Medrio
Mr. McClenney brings with him over 25 years of compliance, regulatory and information technology experience. As Sr. Director Quality Management, his primary focus is on managing the Quality Management team at Medrio and providing a quality management perspective on the business to help ensure compliance with Medrio’s SOPs and relevant regulations and guidelines. Prior to Medrio, Mr. McClenney was Senior Director of Quality Management for a clinical trial technology company, and was the founder and Principal Consultant of a compliance consulting company.
His experience includes quality and compliance oversight of both products and client projects, helping to create and implement system life cycle management documentation; as well as developing procedures and corporate standards governing various areas of Quality Management. Mr. McClenney has spoken on topics such as Data Privacy, Vendor Outsourcing and Support, Infrastructure Qualification, Computer System Validation, and 21 CFR Part 11. He holds a Bachelor’s degree from the University of Virginia and a Master of Science degree in Information Technology Management from the Naval Postgraduate School.