In today’s data-driven world, industries across the board are embracing data standardization to ensure uniformity and maintain organization. This is particularly important for the United States Food and Drug Administration (FDA), as they regulate a wide range of products that people consume or use, such as medications, tobacco, and beauty products. To maintain data compliance, the FDA introduced the Standard for Exchange of Nonclinical Data (SEND) guidelines in 2016, which apply to studies initiated on or after December 17, 2016. Navigating the intricacies of SEND submission can be challenging without proper knowledge and training. In this blog post, we’ll delve into the biggest SEND submission challenges for 2023 and provide practical solutions to help your organization overcome them.
Effective data management has become a critical challenge for many companies, given the exponential growth in the volume of data they must manage. Despite technological advancements, many organizations struggle to keep up with the demands of an efficient and organized data management system.
The FDA’s Center for Drug Evaluation and Research (CDER) program alone receives millions of pieces of data annually. An effective data management system will prevent delays and setbacks.
Consistency is the key. It keeps companies up-to-date with SEND guidelines before each submission.
Companies can check their data with SEND-managed services like Xybion’s SEND Intelligence Services. Every submission will be in alignment with SEND guidelines.
It allows for a standardized format and harmonizes study designs.
It is crucial to ensure that your data is formatted in accordance with SEND (Standard for Exchange of Nonclinical Data) guidelines. Adhering to these standards can be particularly challenging for organizations that have utilized diverse formats over the years.
Data formatting inconsistencies remain a significant hurdle for professionals in this domain. Nevertheless, numerous publishing options are available, making it essential to properly format study data according to SEND specifications.
When the data fails to meet the required standards, it is necessary to employ data transformation services. In this context, Xybion offers SEND Intelligence Services that effectively processes data from various formats, converting it into SEND-compliant structures, ensuring proper organization for submission. Consequently, the files are seamlessly ingested into the SEND platform and standardized in alignment with SEND requirements.
Complying with the ever-evolving requirements and regulations set by the FDA can be daunting, especially for organizations not well-versed in them. In addition, keeping pace with the FDA’s standards can be a significant challenge.
These regulations extend to medications, food products, medical devices, beauty products, and others. Complying with SEND guidelines isn’t always straightforward. The FDA regulatory requirements are constantly changing.
Xybion’s SEND Intelligence Services helps in implementing robust checks and balances to guarantee the compliance and accuracy of your data sets. The services perform validation processes to ensure that the data meets all requirements.
This includes matters like IQ/OQ/PQ protocols and test scripts. Maintaining industry standards expedites the process. It makes sure that you are in alignment with technical specifications.
These SEND-manage services put you in touch with SEND subject matter experts while providing you with a validated environment with regulatory oversight.
Accurately formatting and submitting data is a crucial aspect of any organization’s operations, and a lack of in-house technical expertise can make this process challenging. Therefore, your company must possess the necessary capabilities to execute this task effectively to ensure the integrity and compliance of your data submissions.
Understanding your SEND options is difficult when you haven’t been properly trained. SEND is a detailed process. It requires diligence and an understanding of the industry.
Having in-house technical expertise can greatly facilitate the process of putting together a SEND submission and mitigate the risk of encountering obstacles.
Technical proficiency can streamline the submission process, ensuring a smooth and efficient outcome. When you outsource this work, your company can face challenges with the SEND standard.
Converting extensive data into the SEND guidelines can be cumbersome to your budget and time. In addition, depending on your company’s size, scale, and needs, this cost can be higher.
When submitting information for drugs and other products, time is crucial. Your timeline will become delayed if there are issues with sending SEND data. Trying to do it yourself can lead to time constraints and run up your costs.
For many companies, this means manual data entry. It can be incredibly time-consuming and costly, with potential errors. Data solutions and
Artificial Intelligence (AI) saves your company time and money. There’s more potential to handle your SEND submissions correctly the first time.
Xybion’s SEND Intelligence Services can address these time and cost issues head-on. In addition, the solutions will let you streamline the process.
You’ll be more organized and less reliant on manual entry. They provide SEND outsourcing, SEND organizational consulting, SEND study services, and other solutions. All will keep costs under control.
With these variables under control, a company will face fewer compliance issues. As a result, your organization can become more profitable as a whole.
The SEND submission review period can be frustrating for many companies, as it often involves a lengthy and costly review process. In addition, non-compliance with SEND standards can result in setbacks and delays during the review period, further exacerbating the challenges associated with submitting accurate and compliant data.
These delays can add up when a company handles these matters instead of hiring pros.
SENDIG v3.1.1 assists organizations in maintaining secure, efficient data exchange processes while adhering to industry regulations. By streamlining data exchange, it enables businesses to concentrate on other tasks and activities.
Employing this robust standard allows companies to remain competitive, ensuring the accuracy of exchanged data. Before implementing SENDIG v3.1.1 in your organization or system, it is crucial to comprehend its functionalities and usage.
These primary challenges in SEND submission stem from inadequate training, limited time, and insufficient resources. To successfully comply with FDA regulations and maintain transparency in your correspondence, it’s crucial to have expert assistance. That’s where Xybion’s SEND Intelligence Services comes in. Our comprehensive SEND-managed services simplify the SEND submission process, ensuring your data packages are error-free and compliant. With our expertise at your disposal, you’ll save valuable time, boost productivity, and foster transparency in all your FDA communications.
Don’t let the complexities of SEND submission weigh you down. Talk to one of our SEND experts to fortify compliance and streamline your submissions, allowing your company to enjoy the benefits without any added stress.