Mission3 OnDemand

Mission3 OnDemand makes accessing your information as convenient as possible. Our Software-as-a-Service -based Program Delivery Solutions are delivered across the Internet, providing users with one-stop, comprehensive computing, thus eliminating the need for clients to purchase software or hardware. We maintain all of the hardware, network systems and application software, while you pay only for usage. Best of all, upgrades and feature enhancements are included to you at no additional costs.

Mission3 OnDemand helps life science companies accelerate and optimize their program delivery by providing one integrated, on-demand software solution for all of the key stakeholders involved driving product candidates to market approval. Tightly integrating critical business processes such as project and document management along with collaboration and regulatory submission management into a one suite (21 CFR Part 11 compliant), Mission3's customers can avoid the nightmares and challenges of expensive software licenses, cumbersome implementations and painful business disruptions. OnDemand requires no download and is ready to use right away. With a short training time, you will be able to dedicate your efforts fully to your product production.

Mission3 OnDemand automates and manages business processes within a product development project. One of its unique features is that it allows the association of documents to a task in the project. This provides the ability to easily locate a document in relation to its process. Further, this feature is the backbone that facilitates dynamic reporting on overall project health.

Giving partners or customers access to projects in a very secure manner - in fact roles based access can be granted down to a document or task.

See project progress from a high-level with executive level reports, or comprehensive project manager reports.

Dynamically make decisions based on the information that the system provides in a flexible project management environment.

Bring significant control to the entire Life Sciences development process. If you can imagine the project Mission3 can handle it.

Bring thousands of geographically dispersed project contributors together on a decade long project with complete management visibility and regulatory control.

Document Management

Mission3 OnDemand's document management tools are central to the content creation and validation processes that companies put in place in order to conform to various regulatory mandates around the world. The document management system is tightly integrated with our project management capabilities as well as with the downstream submissions management tools, and provides the following functionality:

• Complete suite of library services for documents including check-in, check-out, document locking and metadata with secure role-based access for global users.
• Rendition capabilities to create "per guidance" PDF documents by converting other file types.
• Creation of "lifecycles" and electronic signatures for documents in order to facilitate their formal review and approval.
• Rich reporting toolkit for all users, comprehensive search documents and pathways, elective notifications via RSS feeds and/or email, "Quick Links" to recent documents and pathways, etc.
• Structured authoring interface complete with formatting and commenting tools and ability to configure reusable document templates.
• Fully compliant with 21 CFR Part 11 regulations.
• Document and user audit trails, with ability to generate downloadable reports.

Submission Management

The Mission3 OnDemand Submission Management solution delivers both significant operational efficiency and a tremendous time-to-market advantage. Submissions can be completed with the push of a button instead of months of labor intensive compilation.

• Pre-configured submission templates for standard formats (e.g. eCTD, PMA, 510 (k)) with the ability to define additional templates for custom assemblies (e.g. for regional affiliates).
• Tight linkage with the Document Management platform allows documents to be easily incorporated into submission structures. We provide the flexibility of linking to specific or latest versions of the document or their PDF renditions.
• Rich metadata support including grouping countries by region, configuring metadata by country, date fields (e.g., registration date, renewal date, etc.), submission types, etc.
• Lifecycle management capabilities to indicate status of submission (in-progress, submitted, etc).
• Ability to configure different user roles with specific rights for content contributors versus reviewers/ validators.
• Link management tool for addressing any cross-document link errors prior to publishing.
• Full support for both electronic as well as paper publishing of submissions using configurable publishing templates with options for volumization, bookmarks, etc., that can be reused across submissions.
• Automated creation of an eCTD package, including the XML backbone, folder structures along with published output.
• Full support for application sequences and variations, using copy and cloning features.
• Integration with GlobalTrack for reporting/tracking of submissions worldwide.

Virtual Data Room (VDR)

Any company involved in business development activity knows the value of a secure and easy-to-use VDR. Mission3 OnDemand's solution provides the following benefits:

• Secure Content Viewing that provides read-only access to latest version of documents in a secure web-based viewer that prevents downloading, copy and paste, or printing.
• Robust interface that supports over 300 different file types in a high-quality topography interface.
• Simultaneous, world-wide, 24x7 access to multiple reviewers across organizations.
• User-friendly reviewing capabilities including zoom, fully navigable table-of-contents and links.
• Screen-only rendition of watermarks to clearly identify content for review.
• Detailed management reports that list pages viewed, who viewed them and viewing duration/time stamps.
• Integration with the Document Management platform allows document updates to be instantly reflected in the VDR interface.

Benefits of Mission3 OnDemand

• Organize your enterprise
• Increase collaboration between your team and partners
• Real-time project management
• Increase efficiency
• Partnership management
• Regulatory submission
• Due Diligence-easy hand off M&A
• Organized data
  • Corporate, Producte, IP, Marketing, Contracts, SOPs, etc.
• Life Sciences exclusive vendor
• Project based licensing model
  • Unlimited users per project and no user or seat licenses
• Easy to administer and maintain the system
  • Minimal IT and validation requirements