CDISC compliant SEND datasets are a mandatory deliverable for FDA regulatory submissions and must be included in your submission package for in-scope clinical studies. If favorable safety results are received, you can begin preparing and filing your Investigational New Drug (IND) application and progress to the next phase of clinical development. For that reason, there’s often a sense of urgency to generate and submit SEND datasets, a process that takes considerable time and programming resources. How can you ensure your SEND datasets are ready for regulatory submissions? Regulatory timeline pressure is just one of several factors contributing to a growing need for SEND dataset services in the biopharma industry. Below, we look at some of the common challenges faced by sponsors in the creation of SEND datasets and examine how flexible service models used in concert with SEND Explorer software can help you overcome these challenges.
Capacity and desired expertise at study sites
Consider the volume of original IND applications the FDA receives each quarter, together with the limited number of providers that offer CDISC SEND dataset programming services, and you can quickly understand how demand is outpacing supply. The FDA receives roughly 190 IND submissions each quarter. In the fiscal year 2021, the most recent year reported by the agency, they received 777 IND submissions. With most IND submissions containing data from multiple studies, the number of SEND datasets required annually is easily over 1,000.
Today, most submission-ready SEND dataset packages are prepared by the CRO that runs the study and produces the final study report. The CROs providing these end-to-end services must keep up with the high demand for SEND dataset services, and do so within sponsors’ shifting timelines. As a result, sponsors can experience delivery delays as their project is added to a long waitlist. Sponsors running studies at smaller facilities or facilities outside of the U.S. are more likely to find a lack of SEND capabilities and require additional services.
In either scenario, securing expert SEND programming services from CROs is a challenge. But there is another option that allows for greater flexibility and control of timelines. In this scenario, a successful handoff from the CRO to an expert statistical programming resource is critical and must include procedures for secure data transfer and maintaining data integrity.
Retroactive creation of CDISC SEND datasets for legacy studies
If you have legacy studies or older study data where SEND was not created at the time the study, you’ll need to retroactively create submission-ready SEND dataset packages where they are required by the FDA. The process of retroactive SEND dataset creation often involves manual data entry using the PDF study report and/or Excel extracts. Sponsors may need to contact CROs involved in the study to obtain electronic source data. Timelines can be longer due to issues with source data quality, manual processes and additional quality control (QC) steps to ensure datasets are correct and complete.
Internal data warehouse initiatives
It is now commonplace for biopharmas to invest in data warehouses that integrate multiple sources of data, to allow for easier, more informed decision-making. Adding nonclinical data to the mix is a natural progression as these warehousing projects mature and expand. To facilitate inclusion of nonclinical data in an internal data warehousing environment, sponsors are taking on large-scale SEND conversion projects.
Several SEND Explorer users recently completed projects to bring historical nonclinical study data into the platform. The aim was to enable query and visualization between this historic SEND data and SEND data for current studies. As part of these projects, custom connectors were built to bring the data into SEND Explorer. Once the legacy data was loaded, SEND Explorer’s multi-study visualizations allowed scientists to leverage this data for historical control comparisons, reference range reporting, cross compound/target analysis, and more.
Evolving industry regulations
Several regulatory changes related to SEND, nonclinical data and submissions came into effect in 2023. More considerable changes are on the horizon, including the finalization and implementation of the next major version of SEND, v4.0.
Related: Read a comprehensive summary of the SEND 2023 updates nonclinical drug developers need to know
While new regulatory requirements aren’t the primary driving force of the industry’s SEND dataset backlog, sponsors must keep in mind two noteworthy changes. As of 2023 年 3 月 15 日, SEND format is now required by the FDA’s Center for Biologics Evaluation and Research (CBER). Previously only submissions to the FDA Center for Drug Evaluation and Research (CDER) required SEND datasets.
SEND compliant formatting is also now required for embryo-fetal development (EFD) reproductive toxicology studies.
Certara offers CDISC SEND programming services and flexibility to meet your needs
Certara’s biostatistical programming team can help you navigate these challenges, and prepare submission-ready, CDISC compliant SEND dataset packages on time, every time. Our team offers flexible delivery timelines for SEND dataset packages and supporting documentation required to support SEND FDA IND and NDA submissions, as well as legacy SEND conversion projects.
Our proprietary software platform, SEND Explorer, allows biopharma organizations and our own experts to use the same SEND datasets for internal scientific data review and data visualization. Both FDA CDER and CBER use our SEND Explorer tool to visualize nonclinical data in regulatory submissions.
Contact our team to learn more about our SEND dataset programming services or nonclinical data best practices.
