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Instem SUBMIT

A comprehensive suite of integrated tools and services for the creation, management and submission of SEND data.

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Overview

Instem's SUBMIT suite is a market-leading solution focused on the Standard for Exchange of Nonclinical Data (SEND). It provides tools for creating, managing, and reviewing SEND datasets, which are a required component of nonclinical study data submitted to the FDA. It helps sponsors and CROs ensure their data is compliant and submission-ready.

✨ Key Features

  • SEND dataset creation and management
  • Data validation against current standards
  • Study data review and analysis tools
  • Cloud-based and on-premise deployment options
  • Services for SEND dataset preparation

🎯 Key Differentiators

  • Deep focus and expertise in the SEND standard.
  • Integration with Instem's preclinical software suite (Provantis).
  • Offers both software and services to support SEND compliance.

Unique Value: Provides a comprehensive, industry-leading solution to manage the complexities of creating and submitting compliant SEND datasets for nonclinical studies.

🎯 Use Cases (4)

Converting nonclinical study data into compliant SEND datasets Validating SEND data before submission Reviewing and analyzing nonclinical data Managing SEND data for multiple studies

✅ Best For

  • Creation and management of SEND datasets for regulatory submissions to the FDA.

💡 Check With Vendor

Verify these considerations match your specific requirements:

  • Companies looking for a general-purpose RIM system or an eCTD publisher.

🏆 Alternatives

Certara Pinnacle 21 PointCross Life Sciences

Offers a more integrated solution when used with other Instem preclinical products and provides a combination of software and expert services.

💻 Platforms

Web Desktop

✅ Offline Mode Available

🔌 Integrations

Provantis (Preclinical software)

🛟 Support Options

  • ✓ Email Support
  • ✓ Phone Support
  • ✓ Dedicated Support (All tier)

🔒 Compliance & Security

✓ GDPR ✓ ISO 27001 ✓ SSO ✓ GxP

💰 Pricing

Contact for pricing
Visit Instem SUBMIT Website →