What is RegTracker?
First, the RegTracker system is a system that keeps track of all pertinent information about product registrations. This includes data about a drug that is part of a registration and hence when changed requires an update of the registration. Since a unique registration for each Trade Name, Dosage Form, and Strength is required in each country where the drug is marketed, the volume of data grows quickly.

Second, it is a project management tool that keeps data about the projects surrounding getting updates and renewals of registrations approved.

Third, it is a reporting tool that allows quick access to consistent and up-to-date information about the registration status of all drugs marketed by the company and its affiliates.

What makes RegTracker unique?
The RegTracker system consists of modern and user-friendly tools that have a short learning curve and short implementation time. The relationships between the data entities that make up the definition of a drug and registration have evolved over many years and are proven by multiple customers.

Does RegTracker manage regulatory submissions?
The RegTracker system can manage the projects surrounding the submissions. It is not a document management tool; however, any number of documents can be associated with any drug on a country-by-country basis including metadata about the documents.

What kinds of documents can we store?
The RegTracker system stores links to documents. This means that any format, size, and type of documents can be managed, including links to images, multimedia and web sites.

Can we link to our EDMS?
The current version of RegTracker can link to an EDMS if there is a mechanism to identify documents in the EDMS by URLs (Uniform Resource Locators), e.g. http://docs/document-identifier

How do we create new reports?
Business Objects Crystal Reports is the tool of choice for creating structured reports and is shipped integrated into the RegTracker product.

What e-mail/groupware systems are supported?
The RegTracker software does not depend on any e-mail or groupware. If you have Microsoft Outlook, you may send e-mails and create tasks directly.

Can you support the fact that we have different manufacturers depending on the market?
Yes. The substance module is used to capture the manufacturers or suppliers that are available for an ingredient. When defining the composition of a product, the manufacturers are available for selection. Since the composition is country-specific, we can capture this fact.

Is there an audit trail?
Yes. There are two types of audit trails. One is “explicit” for the kind of information that is related to your registrations, such as historical trade names, market authorization holders, composition, etc. The other is based on triggers in the database which stores every change made to the database, who did it, and when.

How do we manage users/groups/security?
The RegTracker system comes with an administration tool which is used to create users, groups, set up security and manage all values in drop-down lists. These values may be removed, added, changed and kept in multiple languages.

Is there a Kanji (double-byte) version?
No, there is currently no Kanji version. This is a desirable enhancement for future development and is on the product’s Road Map.

What kind of documentation comes with the system?
The RegTracker system comes with on-line context-sensitive help, which means that hitting the F1 button will display a relevant help topic wherever you are in the product. There is also a hard-copy version of the manual, installation guides, and administrator guides.

How do we migrate the data from our existing systems?
It is possible to migrate most kinds of data into the RegTracker data repository as long it is available in electronic form and is accessible in one way or another i.e. in a database or in an application that has an API. Depending on the volume, a RegTracker implementation may be a good opportunity to clean up your data by keying it in by hand.

Both of these options are available as Professional Services as part of a RegTracker implementation.

What about products in development?
The RegTracker data repository can store data about products both pre- and post-approval. Products can be categorized as “Medicinal Product”, “Clinical Trial Product”, and “Generic Product”.

Is RegTracker integrated with other products?
Integration with other clinical drug development systems is possible and indeed desirable. Specifically integration with Adverse Event Reporting (AER) or Drug Safety systems would be extremely beneficial to supply approval data, work as a drug dictionary, and manage AER system generated Periodic Safety Update Reports (PSUR’s) and other reporting requirements. Discussions have been held with Relsys in particular to develop an integration with the Argus Safety system.Add Content...