Regulatory Submission

Ensure Compliance with High-Quality SEND Data for Faster Submission Preparation

The Importance of High-Quality SEND Data in Regulatory Submissions

In today’s regulatory landscape, the ability to submit high-quality data quickly is essential to achieving timely and successful approvals. The Standard for Exchange of Nonclinical Data (SEND) has become a critical requirement for regulatory submissions, enabling the FDA and other regulatory bodies to review preclinical data in a standardized format. As regulatory demands continue to evolve, ensuring SEND compliance is no longer just a matter of formatting; it’s essential for data integrity, consistency, and transparency throughout the entire submission process.

Instem’s Regulatory Submission Solutions provide end-to-end support for generating, converting, and validating SEND-compliant datasets. By prioritizing quality and consistency, Instem’s SEND tools help organizations ensure their data is always ready for regulatory review, significantly reducing the risk of delays, rejections, or resubmissions. With a complete suite that includes SEND Services and Submit™ software, Instem empowers research organizations to deliver accurate, high-quality datasets quickly and with confidence.

Why High-Quality SEND Data is Essential for Regulatory Success

Accurate SEND datasets not only facilitate regulatory review but also support the integrity and reproducibility of your study data. The FDA and other agencies rely on quality, standardized SEND datasets to streamline their review processes, allowing them to quickly access, interpret, and validate the data. Poor-quality or non-compliant SEND datasets can result in requests for additional data or re-submission, causing costly delays that ultimately slow down the path to market.

Instem’s SEND solutions are designed to meet these high standards, helping clients eliminate common SEND data issues by providing meticulous data validation, preparation, and submission support. By ensuring your datasets meet regulatory expectations from the outset, Instem minimizes risk and facilitates a smoother, faster review process for your submissions.

Instem’s SEND Suite for Regulatory Submission

Instem’s Regulatory Submission solutions consist of two core offerings: SEND Advantage Services and Submit™ software. Together, these tools provide a comprehensive approach to SEND data management, allowing organizations to generate, validate, and submit SEND datasets on their own or with the help of Instem’s SEND conversion experts. Both solutions provide researchers an easy and reliable option for supporting the creation of accurate, consistent, and regulatory-ready datasets that minimize risk and accelerate approvals.

SEND Advantage™ Services: SEND Conversion and More

Instem’s SEND Advantage™ Services offer a fully managed, end-to-end solution for generating SEND-compliant datasets. Whether you’re submitting preclinical data for an investigational new drug (IND) application or meeting regulatory requirements for new drug applications (NDAs) or biologics license applications (BLAs), Instem’s SEND Advantage™ Services team of experts ensure that every dataset they generate meets stringent regulatory standards. These services go beyond data conversion, and also provide compliance checks, consultation and education programs, as well as data management for legacy usage.

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Instem’s SEND Advantage™ Services include

SEND Deliver™: Leveraging new processes, a larger team, and leading proprietary technologies, Instem rapidly turns manual or electronic data into SEND with all supporting documentation & metadata.
SEND Comply™: Conformance checks, dataset verifications and remediation services performed by our team of SEND experts.
SEND Advise™: Tailored on-site or remote consultancy and education programs.
SEND Warehousing Services: Transforming legacy data into structured datasets that provide value beyond compliance.
SEND Source™: Flexible SEND partnership programs that offer professional staff augmentation, partial or full outsourcing services.

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Key Benefits of Instem’s SEND Services

Data Quality and Consistency: Instem’s SEND experts perform rigorous quality checks throughout the dataset creation process, identifying and addressing any data inconsistencies or errors that could hinder regulatory review.
Regulatory Compliance: With years of experience in regulatory submission, Instem’s team ensures that each dataset adheres to the latest SEND Implementation Guide (IG) requirements, reducing the risk of non-compliance.
Efficiency and Scalability: SEND Services are designed to support organizations of all sizes, from small biotech firms to global pharmaceutical companies, with scalable processes that can handle both single-study and large, multi-study submissions.

In addition to data quality checks, Instem’s SEND Advantage™ Services provide detailed guidance on dataset structure and formatting, helping clients understand how their legacy data can provide value beyond compliance. By partnering with Instem for SEND Services, clients can streamline their submission timelines, improve data accuracy, and ensure compliance with regulatory standards, ultimately enabling faster drug approvals.

The Submit™ Software Suite: Streamlined Management for SEND Data Submissions

Submit™ is Instem’s powerful SEND submission management suite, designed to simplify the process of organizing and generating SEND data for regulatory filings. Submit offers a variety of tools that allow teams to centralize all SEND data within a secure platform, supporting both automated data updates and real-time version control to keep submissions accurate and compliant. With intuitive tracking and secure access features, the Submit suite helps research teams manage and generate SEND data quickly, reducing administrative burdens and ensuring consistent data quality.

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Key Features of Submit

Centralized Data Control: Submit provides a single, secure platform for managing all SEND data, ensuring that teams can easily track, organize, and retrieve datasets for regulatory purposes.
Automated Updates and Version Control: By automating data updates and implementing rigorous version control, Submit ensures that all data remains consistent and compliant throughout the submission process.
Seamless Integration with SEND Services: Submit integrates seamlessly with Instem’s SEND Services, allowing teams to easily transition from dataset preparation to submission without data transfer or formatting issues.

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Features & capabilities of Submit™ include

SENDirect™: Import data from any source and convert it into SEND
DefineNow™: Quickly create and edit CDISC compliant and submission-ready define.xml files – also available as a standalone tool
GuidePro™: Reduce the time for nSDRG development by up to 50% with our automated guide generator
SEND checker: Ensuring datasets conform to the IG rules
SEND editor: Secure, fully audited bulk dataset edits
SENDView™: Simplified data review & QC checking – also available as a standalone tool
SEND Workflow & File Management: Fully automated workflows for securing & processing SEND datasets
Secure storage: Fully version-controlled file store of all data files & SEND datasets

With Submit, regulatory teams have greater visibility into submission workflows and can quickly respond to any regulatory feedback by making adjustments within the same system. This eliminates the time-consuming process of re-formatting or transferring data, further expediting the regulatory review cycle and reducing the overall time to approval. By providing an organized, compliant approach to data submission, Submit helps clients maintain high-quality SEND data and avoid potential setbacks, ultimately improving submission efficiency and accelerating the path to market.

The Instem Advantage: A Holistic Approach to SEND Compliance

Instem’s Regulatory Submission solutions stand out for their focus on quality, compliance, and efficiency. With nearly two decades of experience in regulatory data management, Instem understands the complexities of SEND submissions and the high standards required for approval. Instem’s approach to SEND data preparation combines advanced technology with deep regulatory expertise, ensuring that clients are always equipped to meet evolving FDA requirements and avoid costly delays.

Additional Advantages of Instem’s Regulatory Submission Solutions:

Expert Consultation and Support: Instem’s SEND specialists offer in-depth consulting to help organizations navigate complex SEND requirements, from initial dataset creation to final submission.
Continuous SEND Compliance Monitoring: Instem stays up to date with the latest SEND IG updates, ensuring that clients benefit from the most current guidance and regulatory insights.
Commitment to Data Integrity: Instem’s Regulatory Submission solutions are built to protect data quality and integrity at every stage, allowing organizations to confidently submit datasets that reflect the highest standards of accuracy.

Accelerate Your Path to Approval with Instem

In an industry where speed and precision are essential, Instem’s Regulatory Submission solutions provide the expertise, tools, and processes needed to prepare, manage, and submit high-quality SEND data with confidence. By leveraging Instem’s SEND Advantage™ Services and Submit™ tool, organizations can streamline their regulatory workflows, reduce administrative burdens, and eliminate the risks associated with poor-quality data. With Instem as a partner, your organization can achieve faster, smoother submissions and bring new therapies to market more quickly.

Get Started with Instem’s Regulatory Submission Solutions

Ready to experience the benefits of Instem’s Regulatory Submission solutions? Schedule a personalized demo to explore how Instem’s SEND Advantage™ Services and submit™ can enhance your data preparation and submission processes, ensuring high-quality, compliant datasets for faster regulatory review.

Request a Demo Speak to Our Experts

Donna Robinson

Chief Commercial Officer