Regulatory Information Management FAQs

Regulatory Information Management FAQs

 

Regulatory Information Management FAQs

 

RIM Frequently Asked Questions:

1. Is Synchrogenix’s GlobalSubmit Regulatory Information Management (RIM) solution available in the CLOUD?

Yes. GlobalSubmit COMMUNICATE and MANAGE are all available in our hosted, Secure CLOUD deployment. Amazon Web Services (AWS) is the third-party provider for our multi-tenant, CLOUD solution.

2. Do you have a product for tracking phone calls and emails between a company and a regional health agency?

GlobalSubmit COMMUNICATE includes an Agency Correspondence module that can be used to collect and sort any information exchanged with regulators. The Agency Correspondence module is a central hub that can be accessed by anyone in your organization exchanging such information, which will provide superior transparency and search capabilities as compared to emails and spreadsheets.

3. Does your RIM product offer any integration with GlobalSubmit’s eCTD suite?

Yes. The RIM suite and the eCTD suite will be integrated. Initial implementation will offer, at minimum, advantages in opening and managing applications and sequences through one system, reducing the need to perform multiple workflows. Future product roadmap plans will focus on creating smart features that share information between suites greatly reducing redundancy and eliminating the potential for conflicting information.

4. What regions does the tool support?

The RIM suite will offer standard support for all eCTD and NeeS regions, and can be easily customized by the administrator to support additional, non-standard regions.

5. Does GlobalSubmit RIM provide for “role based” customization based on information relevant to each user?

The RIM suite was deliberately broken up into an interoperable product. Each product focuses on various Regulatory Affairs and product development roles. Whether you are a Submission Publisher, Regulatory Affairs Executive for EU products, a Medical Writer for two products or an Informatics Manager looking to product metrics on historical and future work, you can create your own customized experience based on products, modules and filters. Hundreds of users can have hundreds of preferred views and reports, all managed at the user level without administrative support.

6. What is a typical implementation timeline for your RIM products?

Implementation for any of the RIM products is fairly straightforward. The systems are deployed in our Secure CLOUD deployment, thus limiting the time spent on cumbersome installation processes. Users are assigned secure licenses and gain access online. Approximately 2-4 hours of training and exercises are needed prior to putting the system into production.

7. Can the RIM products (COMMUNICATE and MANAGE) be purchased individually or bundled?

The products can be purchased individually, or bundled. All products can be integrated at any time.

8. Can seat licenses be customized per product?

Yes. For example, a company could implement 50 seats of COMMUNICATE and 30 seats of MANAGE. Seats can be added or removed at any time. Companies can now manage their budgets with more accuracy and get full value out of their purchases.

9. Will I be able to generate reports? For example, I’d like to see how many submissions my company sent to the FDA in 2014. Another scenario would be looking at the agency correspondence for a certain product in the EU.

Viewing and reporting on data housed in COMMUNICATE and MANAGE can be accomplished with a few mouse clicks. Reports will display data based on time increments (month, year), submissions, products, regions, publishers, regulatory status, and so on. You can then choose to export data in the form of a report or save the custom view you’ve built for future use. The RIM reporting functionality replaces status quo methods such as manually combing through spreadsheets to locate information and setting up complicated queries to replicate reporting.

10. We have decided to submit our product marketing application to a number of agencies outside of the US and we’re concerned about tracking commitments and milestones. Can RIM support global production?

Yes. GlobalSubmit’s RIM products support companies with global regulatory initiatives. COMMUNICATE includes functionality to record, report on and track commitments for products across multiple regions. As the scope of your regulatory activities grows, you can track approvals through the MANAGE system.

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