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Submit™

Submit logoSolution Snapshot

Submit™ is the only fully integrated Non-Clinical solution developed to support the FDA's adoption of a standardized format for collecting, organizing and exchanging research data.

The submit solution is a fully scalable set of software modules to facilitate the conversion of data from any source system into SEND format. The tools further allow the FDA, sponsors and their partners to visualize and analyze SEND formatted data on-demand through an intuitive Web-based system.

Business Benefits

  • Advances pipeline by automating & streamlining submissions
  • Reduces manual processes
  • Increases performance without increasing headcount
  • Reduces errors
  • Enables efficient exchange of data between sponsors and CRO's
  • Allows you to ‘have the eyes’ of the FDA
  • Streamlines data acquisition & submission systems
  • Demonstrates clear market leadership

Submit™ System Architecture

submit system architecture diagram

 

Submit is supported by professional Instem Solution Services that meet your needs and is governed by a rigorous methodology to ensure successful outcomes - on time and to budget.

Options to Fit Your Needs

Submission-Based Pricing

A fixed price project for single submissions

Fully discounted if upgrading to Subscription-Based plan within 7-months of purchase

Subscription-Based

Traditional license arrangement allowing for unlimited number of site-based submissions

  • Live and local Help Desks
  • Completely validated processes
  • Ability to deploy resources globally
  • Protection of your IT investment
  • FDA supported

Our SENDReady Guarantee

Join us in supporting this important initiative and by becoming SENDReady now, you will have peace of mind knowing that your costs will be contained, that you will be SEND-enabled and ready to submit within 90-days of the FDA's final guidance. Through submit, will take the additional step and ensure that any changes in the submission standards before or after guidance are included.

Benefit by being Proactive

The FDA is urging industry to begin planning how they will respond to the new SEND standards and is ready to issue final guidance. They see this initiative as part of the vital program in helping to bring new discoveries to the public more quickly, efficiently and safely.

Join other leading organizations by speaking with us today. We offer cutting edge technology solutions that were developed with industry and the FDA - for you to realize operational efficiencies while supporting the FDA in its quest to overcome the challenges of managing vast amounts of critical information.

submit system diagram

Schedule Your SENDReady Analysis Today

SENDReady Analysis - Understanding Your Options…
Our SENDReady Analysis is a professional consultative visit that assesses your environment, all of your source systems and delivers a functional, value-added and objective report. It clearly recommends in detail your options for becoming SEND-enabled with or without deploying a submit solution, and why.

To discuss your SENDReady Analysis please contact us at:

Tel: (610) 941-0990 or e-mail: submit@instem.com