Submit

Submit is a sophisticated software suite that simplifies the process of creating and managing Standard for Exchange of Nonclinical Data (SEND) datasets and accompanying documentation. Designed by SEND experts, this suite facilitates regulatory submissions for preclinical studies, ensuring dataset accuracy and compliance with minimal frustration.

Organizations face significant challenges in managing data precision, maintaining accurate records, and ensuring adherence to regulations during preclinical studies. The conversion to SEND format further complicates data management. Submit addresses these needs by providing a complete set of features that streamline the transition from data collection to regulatory submission.

Submit improves the exchange of essential study data among sponsors, Contract Research Organizations (CROs), and regulatory bodies, enhancing submission speed and quality. This helps teams overcome obstacles in the submission process and accelerates the introduction of innovative therapeutics to the market.

Key Benefits of Submit

• Supports Compliance: Ensures datasets comply with the latest SEND Implementation Guide rules.
• Boosts Efficiency: Workflow automation, automatic data conversion, and autochecks streamline data preparation, review, and submission, saving time and resources.
• Improves Dataset Consistency and Accuracy: Consistent and accurate datasets reduce review and editing time, enhancing data integrity.
• Saves Time and Resources: Automated processes and streamlined workflows reduce time and costs associated with generating and reviewing SEND datasets.
• Enhances Capabilities: Organizations can produce SEND datasets efficiently, expanding their service offerings.

Core Features/Modules

Submit offers a modular design, allowing teams to select specific features according to their SEND requirements. Each module supports a distinct step in the SEND preparation process and can be integrated into any stage of the laboratory workflow.

• SENDirect™: Convert electronic data from various sources into SEND format with terminology mapping, integrating data from multiple systems into a cohesive dataset.
• DefineNow™: Quickly create and edit submission-ready, CDISC-compliant define.xml files.
• GuidePro™: Automated guide generator reduces nSDRG development time by up to 50%.
• SEND Checker: Comprehensive dataset reviews ensure compliance with the current SEND Implementation Guide, incorporating sponsor-specific rules and OpenCDISC checks for validation.
• SEND Editor: Securely perform audited single or bulk dataset edits.
• SEND Visualization and Analysis: Create heatmaps, view graphs, and correlate clinical and preclinical findings for deeper insights.
• SENDView™: Collaborative review and quality control of SEND data.
• SEND Workflow and File Management: Automate workflows to secure and process SEND datasets and related documents.
• Secure Storage: Version-controlled file storage for long-term dataset preservation.