Submit

Submit™ is an all-in-one software suite designed to streamline the creation and management of Standard for Exchange of Nonclinical Data (SEND) datasets and associated documents. It is trusted by Contract Research Organizations (CROs) and sponsors globally to enhance the speed and quality of dataset submissions, allowing teams to focus on bringing life-changing therapeutics to market.

Designed by SEND experts, Submit simplifies regulatory submissions for preclinical studies, ensuring data accuracy, robust record maintenance, and compliance. It facilitates efficient data exchange between sponsors, CROs, and regulators, helping organizations overcome submission challenges and accelerate the market introduction of innovative therapeutics.

Key Benefits of Submit

• Supports Compliance: Ensures datasets meet the latest SEND Implementation Guide rules, supporting compliance consistently.
• Boosts Efficiency: Automates workflows, data conversion, and checks, streamlining dataset preparation, review, and submission.
• Improves Dataset Consistency and Accuracy: Guarantees high-quality, consistent datasets, reducing review time and enhancing data integrity.
• Saves Time and Resources: Minimizes time and resources spent on generating and reviewing SEND datasets, lowering submission costs.
• Enhances Capabilities: Enables quick and efficient SEND dataset generation, allowing organizations to expand and offer advanced services.

Submit's modular design offers standalone features tailored to SEND needs, allowing teams to select necessary tools. Each module executes a complete step of the SEND-readiness process and can be integrated at any workflow stage.

Core Features/Modules

• SENDirect™: Converts electronic data from any source into SEND format, integrating data from multiple systems into a single dataset.
• DefineNow™: Quickly creates and edits CDISC-compliant, submission-ready define.xml files.
• GuidePro™: Automates nSDRG development, reducing time by up to 50%.
• SEND Checker: Performs comprehensive dataset reviews for compliance with SEND Implementation Guide and sponsor-specific rules.
• SEND Editor: Enables secure, audited single or bulk dataset edits.
• SEND Visualization and Analysis: Offers data heatmaps, multiple data graphs, and insights into clinical adverse events.
• SENDView™: Facilitates collaborative review and quality control of SEND data.
• SEND Workflow and File Management: Automates workflows for securing and processing SEND datasets and documents.
• Secure Storage: Provides version-controlled file storage for long-term data file and SEND dataset storage.

Submit is the preferred choice for those seeking a reliable regulatory submission solution. Its seamless integration of features like SENDirect and DefineNow, along with tools like GuidePro and SEND Checker, enhances efficiency, accuracy, and compliance. With comprehensive workflow automation and secure storage, Submit ensures accuracy and consistency, empowering organizations to meet SEND requirements confidently.