FastCrossing

Take advantage of a graphical web-based enterprise solution rather than a cumbersome client-based tool. Easy to deploy and maintain. A centralized server - FastCrossing truly enables your enterprise and partners to collaborate on submissions with the most comprehensive submission features available.

Create

Easily deploy a submission management application that automatically creates and packages electronic submissions for global regulatory bodies including U.S. Food and Drug Administration (FDA).

FastCrossing has been designed with knowledge of what is needed for submission types and individual regional requirements. The submission structure is constructed and validated in real-time before you submit, saving valuable time and resources.

FastCrossing's graphical user interface allows submission content to be selected and placed correctly in the eCTD submission structure. FastCrossing constructs the XML required for the submission table of contents automatically according to eCTD specifications.

Manage

Manage submission lifecycles automatically. FastCrossing manages the full set of submission lifecycle criteria of the eCTD automatically. Configure users to manage, review, or approve content, create new submissions or projects and drive the process from initial application to market approval from a single powerful solution.

Collaborate

FastCrossing's Web-based environment allows for collaboration across the enterprise and with partners. Collaboration between sponsors, consultants, contractors, CROs and labs enables real-time submission creation, review, and approval. Rapidly completing the submission. FastCrossing has no user licensing component - further enabling collaboration.

Integrate

MissionFire integration allows FastCrossing to link to documents managed by the document management solution the minute they are created. FastCrossing manages the relationship to a specific version or latest version of that document, automatically. Ensuring the submission is always up-to-date.

FastCrossing's Web-based technology can be used either as an add-on module for MissionFire, Mission3's compliance documentation management software or as fully configurable standalone solution.

Features -

• Early Binding - Link to a document the moment they are created – FastCrossing will track them through their lifecycle - allowing push button submission after all the content is available.
• Early Linking - full support for cross document linking without the need to create the links manually in the submission system or after the submission is compiled. Linking in native applications are automatically mapped to the targets in the eCTD output.
• Cloning - Clone all or part of a submission to a different region, indication or dosage. Changes in the source are automatically inherited to the clone. Save vast amounts of time and effort while ensuring quality and consistency of submission data. The ultimate data reuse model.
• Full STF support - Study Tagging files are comprehensively supported. The STF interface is available in the proper context of the submission and studies are automatically grouped for inclusion.
• Full regional support - All regional guidance's are supported and simple contextual interfaces guide users through the regional configurations.
• Submission comparison - Easily view and compare all differences between any 2 submissions, sequences, or clones.
• Electronic Signatures - CFR 21 part 11 compliant electronic signatures complete the submission workflow solution.
• Submission Ready PDF creation - Automatically create submission ready PDF files per regulatory guidance.
• Reporting - Complete management, audit and submission level reporting across the application.