Synchrogenix’s GlobalSubmit COMMUNICATE for health agency correspondence and health agency commitments is a reliable, scalable regulatory information management (RIM) system for capturing, tracking, managing, and acting upon vital regulatory information.
COMMUNICATE was designed as an improved, and realistic, user experience for regulatory professionals short on alternatives. In all likelihood, you’ve been left to choose between two options not closely aligned to organization goals — costly, overly complex systems or homegrown mash ups consisting of spreadsheets and documents with conflicting information.
Our solution emphasizes the end user experience while capturing all of the important information your department needs to respond to Agency requests and fulfill commitments in a timely manner. Regulatory professionals can easily customize the system to fit their needs. For example, a Regulatory Affairs Manager working for a large pharmaceutical company with dozens of products globally is able to easily apply a filter in COMMUNICATE to display only commitments relevant to their role.
GlobalSubmit COMMUNICATE allows a user to create an accurate record of non-submissions information exchanged between sponsor and agency — a fundamental day-to-day responsibility for regulatory professionals. Those records can then be accessed and shared throughout a product’s lifecycle to inform critical development, promotional, and compliance decisions.
Featuring a user-friendly design, COMMUNICATE takes large amounts of information across many products, and potentially multiple agencies, and distills it down into smart user categories.
GlobalSubmit COMMUNICATE is a sensible solution for tracking what commitments were made to various agencies and when those commitments are due. For example, you would track 483 responses due resulting from an audit as commitments in the system.
Our solution simplifies entering, tracking and meeting commitments on time with complete internal transparency. The risk of having a study placed on hold, taking a manufacturing site offline or a cancelled marketing license is mitigated.
- Refer back to record of non-submissions correspondence such as emails and phone calls
- Sort information and apply filters to create smart views for each user role
- Display commitments by Agency or individual product
- Real-time reports based on future commitments, historical correspondence
- Visibility, access for all team members in the CLOUD
- Difficult to access and act upon stored regulatory intelligence due to overly complex, nested hierarchies
- Unreliable DIY systems don’t provide adequate visibility, reporting across regulatory teams
- Status quo RIM systems not representative of real world user roles
- Collected regulatory data is not secure nor its contents dependable