Steps to Comply with the FDA’s Binding Guidance on Electronic Study Data Submissions
On December 18th 2014, the FDA issued binding guidance regarding electronic submissions of nonclinical study data. This means that beginning in 2017, any organization making IND, NDA or BLA submissions of nonclinical studies will need to plan for, and be ready, to submit their studies in the required standardized digital format that is directly consumable by the FDA’s NIMS review and analysis tool.
The links provided at the end of this white paper point to useful reference documents. These include the FDA guidance and technical specifications, as well as Agency presentations on the tools and processes they have in place to modernize regulatory reviews through the use of standardized data. The FDA uses their NIMS system to perform data fitness checks on submitted standardized studies and to present them to the medical reviewers.
NIMS is an implementation of the PointCross DSIMS™ product. PointCross Life Sciences has been working closely with the FDA for the past three years to prepare for this important change by:
- Implementing NIMS
- Standardizing FDA selected studies from current NDA and IND submissions for review by FDA in NIMS
- Conducting clinics to orient reviewers on analyzing studies on NIMS under the FDA’s JumpStart Nonclinical service.
To build an effective readiness plan for compliance, sponsors will need to involve internal business, IT, Data Management, Regulatory Affairs and external stakeholders, such as CROs and other service providers who participate in the data collection and submission processes. Compliance means that sponsor organizations must learn how to model studies into the FDA’s implementation of the CDISC SEND exchange standard, create define.xml files, manage controlled terminologies, analyze study data like FDA reviewers, prepare study data review guides, and package data into the required submission structures. Quality assurance controls will need to be applied across the data preparation and submission lifecycle. Sponsors will need to work closely with qualified service and technology providers to rapidly establish new processes and tools in time to routinely submit SEND formatted data packages compliant with FDA specifications. Done correctly and in the right spirit this can be a transformational process that will shave costs, minimize risks for your organization and reduce time to market.