Submit

Submit™ is an all-in-one software suite developed by Instem, designed to simplify the creation, management, and submission of Standard for Exchange of Nonclinical Data (SEND) datasets and associated documents for preclinical studies. Built by SEND experts, Submit is trusted by contract research organisations (CROs) and sponsors worldwide to enhance the speed and quality of regulatory dataset submissions, enabling teams to focus on their primary mission of bringing life-changing therapeutics to market.

Managing data accuracy, maintaining robust records, and ensuring compliance in preclinical studies is inherently complex, and converting data into SEND format adds a further layer of difficulty. Submit addresses this challenge by providing a comprehensive, modular suite of tools that facilitates the efficient exchange of critical study data between sponsors, CROs, and regulators — helping organisations overcome submission hurdles and accelerate time to market.

Key Benefits

• Supports Compliance: Submit ensures datasets meet the latest SEND Implementation Guide rules, supporting regulatory compliance with every submission.
• Boosts Efficiency: Full workflow automation, automatic data conversion, and autochecks streamline the preparation, review, and submission of datasets, freeing staff to focus on more critical tasks.
• Improves Dataset Consistency and Accuracy: Submit ensures all datasets are consistent, accurate, and high-quality, reducing review and editing time and strengthening data integrity.
• Saves Time and Resources: By automating key processes and streamlining workflows, Submit minimises the time and resources teams spend generating and reviewing SEND datasets, cutting overall submission costs.
• Enhances Capabilities: Submit allows organisations to generate SEND datasets quickly and efficiently, enabling them to expand their services and offer advanced capabilities to clients.

Core Modules and Features

• SENDirect™: Effortlessly generates SEND datasets by converting electronic data from any source into SEND format. Terminology mapping allows users to collect data in familiar terms while automatically converting it to SEND Controlled Terminology. SENDirect also integrates data from multiple source systems into a single, study-aligned dataset.
• DefineNow™: Quickly creates and edits CDISC-compliant, submission-ready define.xml files.
• GuidePro™: An automated nonclinical Study Data Reviewer's Guide (nSDRG) generator that reduces the time for nSDRG development by up to 50%.
• SEND Checker: Performs comprehensive reviews of datasets to ensure compliance with the current SEND Implementation Guide. Supports sponsor-specific rules and integrates OpenCDISC checks for robust dataset validation.
• SEND Editor: Enables secure, fully audited single or bulk edits on datasets.
• SEND Visualization and Analysis: Creates heatmaps for all data, allows simultaneous viewing of multiple data graphs, and enables clinical adverse events to be viewed alongside preclinical findings for deeper insights.
• SENDView™: Supports collaborative review and quality control of SEND data.
• SEND Workflow and File Management: Creates fully automated workflows for securing and processing SEND datasets and associated documents and files.
• Secure Storage: A sophisticated, version-controlled file storage module providing a long-term storage solution for data files and SEND datasets.

How Submit Works

1. Data Integration and Preparation: SENDirect integrates and converts data from multiple sources into a compliant SEND dataset. Additional tools support the creation of compliant define.xml files and streamline nSDRG generation.
2. Validation and Quality Control: The SEND Checker performs automated reviews of datasets to ensure compliance with the latest SEND Implementation Guide guidelines, including sponsor-specific rules.
3. Editing and Analysis: The SEND Editor enables secure, auditable dataset edits, while SEND Visualization and Analysis tools provide insights through heatmaps and graphs, including side-by-side views of clinical and preclinical data.
4. Submission and Storage: Workflows are automated for submission, and SEND datasets are securely stored with version-controlled file management for long-term access and compliance.

Submit features a modular design, allowing organisations to select only the tools they need. Each module executes a complete step of the SEND-readiness process and can be implemented at any point in a lab's workflow. The platform supports sponsor-specific customisation, ensuring submissions meet both regulatory and individual organisational standards, and is trusted globally by CROs and sponsors seeking regulatory excellence in nonclinical data submissions.