The U.S. Army Medical Research and Materiel Command's Enterprise Information Technology Project Management Office helped the U.S. Army Medical Materiel Development Activity submit its first in-house developed, all-electronic, Investigational New Drug application in electronic Common Document Format to the U.S. Food and Drug Administration on Sept. 30, saving the organization time and money.
The FDA uses eCTD, a regulatory information technology platform, for electronic regulatory submissions. The eIT PMO's eCTD product has enabled USAMMDA's Division of Regulated Activities and Compliance to produce submissions in-house.
The eIT PMO team worked closely with USAMMDA's subject matter experts throughout all phases of the eCTD implementation and launched the FDA-compliant product on Aug. 28. One month later, DRAC sent its first eCTD submission, a Military Vaccine Agency-sponsored IND application to evaluate different routes of immunizing soldiers with the yellow fever vaccine. A second IND submission followed for the Immunization via Mosquito Bite with Radiation-attenuated Plasmodium falciparum Sporozoites on Oct. 16.
Of the impact DRAC's adaptation of eCTD has made in eliminating the need to outsource work, DRAC Director, Dr. Robert Miller, commented, "USAMRMC can now produce FDA mandated eCTD formatted submissions cheaper-as much as 40 percent -than a contractor and retain complete control of the regulatory documents."
The DRAC team has been working to train themselves on how to prepare, publish, and view submissions in an electronic format since eCTD became operational.
"There is a significant learning curve; however, we have spent several years bringing the individual documents up to the standards necessary for electronic submissions. We are still learning, but these preparatory steps have proved invaluable," said Medical Writer Jennifer Secula.
"We are now learning to fully understand and utilize the modular nature of the eCTD format. With eCTD, we not only need to think about where all of the information should go, but also how the information is interlinked and can be cross-referenced within the submission," added Regulatory Affairs Scientist Adam Bell.
While DRAC stores and manages submis¬sion information in the eIT PMO's Electron¬ic Document Management System, the in¬tegration between EDMS and eCTD enables staff to streamline its review and publishing processes. DRAC staff attests that perform-ing eCTD publishing in-house significantly improves processes from project planning to submission archival.
"Up to this point, it was as if we were building a large jigsaw puzzle without the picture on the box," said Secula of the many moving parts that have now been integrated with the use of EDMS and eCTD.
According to Bell, having an all-in-house system allows scientists to participate in last-minute decisions about content. He ex¬plained that this relatively simple concept was nearly impossible when an electronic submission was prepared externally, or a large paper submission was in-production. Bell added that the system's full integration of newly introduced amendments with early and subsequent submissions enables the team to create a final integrated, single-file application for the licensing of a new drug that is easy to navigate and review.
DRAC Regulatory Operations Chief Tracy Ulderich agreed with this assessment, not-ing that eIT PMO has been an ideal part¬ner in enabling the team to forge ahead smoothly. "Working with the eIT PMO as a local resource with a swift response time has also helped us to avoid timely setbacks for IT-related issues," said Ulderich.
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