The industry is submitting more electronic regulatory applications in eCTD format. The US FDA, strongly recommends that clinical trial data in these applications be submitted in CDISC SDTM compliant format. For companies racing to meet submission deadlines, early detection of potential data conversion and compliance issues is critical. During this webinar, Mr. Evans and Mr. Chow will explain data validation and why it is so important in the evolving electronic submission environment. The presenters will review Octagon's three-tiered approach to data validation that offers flexibility and enables clients to leverage Octagon’s expertise to improve data integrity. The presenters will also share insight into the agency’s processes for accepting electronic regulatory applications and their processes for receiving, validating and storing electronic clinical data.
Mr. Evans is a senior technology and clinical research executive with over 20 years of professional experience in the clinical research, regulatory and healthcare industries. It is because of his extraordinary experience that he is recognized industry-wide as a leading technology visionary for developing and implementing complex process and system solutions. Mr. Evans was also the architect and developer of the first electronic submission to the FDA in 1985 and has been responsible for over 70 electronic submissions and complex clinical data warehouses. He is a frequent industry speaker and has led numerous industry committees and conferences.
Mr. Chow has over 14 years of professional experience in data integration and software implementation. In his current role at Octagon, he serves as the lead technical architect for the development of CDISC SDTM data conversion strategies. Prior to Octagon, he served as Senior Consultant, Communications and Content at BearingPoint, Inc. where he held various technical lead and liaison positions. “It is important for companies to take the time to validate their electronic clinical data prior to submission,” noted Mr. Evans. “Sponsors would never send an eCTD submission to the agency without validating its compliance with eCTD specifications and guidelines. Sponsors must now get in the habit of viewing their electronic clinical data in the same manner and ensuring compliance prior to submission. If you have concerns about compliance with CDISC SDTM, finding issues and addressing them prior to submission is much more acceptable than having the agency find them for you.”
To register for this Webinar, please visit our website or contact Samantha Tolman at stolman@octagonresearch.com, or by phone at 610-535-6500 ext. 5606.
About Octagon Research Solutions, Inc. Octagon is a pioneer and leading provider of breakthrough software and services to the life sciences industry. Octagon’s eCTD, and CDISC solutions provide the people, process and technology required to optimize drug development from data collection to submission. Our regulatory, clinical, process and software offerings provide a unique combination of deep domain knowledge, cross-functional electronic submission expertise, a holistic process approach, and integrated solutions. Octagon is headquartered in Wayne, PA, with European headquarters in Berkhamsted, UK. Octagon’s EDC Operations are located in Mountain View, CA. For more information please visit www.octagonresearch.com.
