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Wayne, PA, United States, 2007/02/08 - Jim Walker of Octagon Research Solutions, Inc., today announced that the company has successfully completed the requirements to send electronic submissions through the U.S. FDA ESG (Electronic Submission Gateway) in a production environment.
CEO & Chairman Jim Walker of Octagon Research Solutions, Inc., a pioneer and leader in the electronic transformation of clinical R&D in the life sciences industry, today announced that the company has successfully completed the requirements to send electronic submissions through the U.S. FDA ESG (Electronic Submission Gateway) in a production environment. The registration process requires that an organization work with the agency to ensure successful transmission of compliant test data. Preparations and testing activities also include acquisition of a digital certificate, submission of a letter of non-repudiation and confirmation of system requirements.
“This capability is important to Octagon because we support our clients in all aspects of electronic submissions including fulfilling the role of agent,” noted Nancy Smerkanich, vice president, Regulatory Affairs at Octagon. “This efficient method of transmission allows us to provide extended value to our service clients. By sending outsourced submissions through the gateway, we are shaving time from the submission development process that was previously wasted on traditional mail methods.”
The FDA ESG enables the secure submission of regulatory information for review and provides a centralized, agency-wide communications point for receiving electronic regulatory submissions securely. Already the agency is reporting increased use of the gateway for submissions going to CDER, CBER and CDRH.
“We are very pleased to have completed the registration process,” commented Patrick Thomas, associate director, regulatory affairs at Octagon. “The agency has provided a great opportunity for industry to save time and money in the transmission of electronic submissions. We are happy to be able to offer submission through the gateway to our growing list of service clients.”
To learn more about the gateway, please visit the FDA website.
About Octagon Research Solutions, Inc.
Octagon is a pioneer and leading process-centric solutions provider that offers a suite of regulatory, clinical, process, and IT solutions to the life sciences industry. Octagon synchronizes processes and increases automation to reduce island-to-island inefficiencies within the clinical research and development process. We leverage the power of electronic submissions through cross-functional electronic submission expertise, a holistic process approach, deep domain knowledge, and integrated solutions. Octagon is headquartered in Wayne, PA, with European headquarters in Amersham, UK.