RAPSTAR provides your Regulatory Affairs department a fully audited tool to monitor and track the following critical functional areas.

Tracking of Clinical Trial Activities

An application to conduct a clinical trial in the European community must be submitted to each Authority in which you intend to submit the clinical trial, along with a variety of different documents, some of which are specific to individual Authorities.

• Tracks Protocol Submission, Translations, and Amendments

• Clinical Trial Application Process

• Notification of Amendment

• Declaration of the End of a Clinical Trial

• Request for Scientific Advice

• Review Timeline

Tracking of Marketing Activities

There are a number of defined stages in the marketing authorization application process where there is intense activity between the Regulatory Agencies and a pharmaceutical company. The tracking system enables the pharmaceutical company to respond to queries from the numerous Agencies in a timely fashion.

• Agency Correspondence Tracking

• Translations

• Post-Marketing Activities

• Variations to a License

• Renewals

Tracking of Pharmacovigilance Activities

Each year, the pharmaceutical company is required to submit to the Authorities a report of all the Serious Adverse Events that have been received from the ongoing clinical trials in the EU. The Annual Report in RAPSTAR provides this information. 

• Serious Adverse Event Tracking per Trial

• Annual Report and Product Safety Update Report

Benefits

Getting a product to market even one month early can mean substantial incremental revenues to a pharmaceutical company. 

When there are a variety of activities occurring at the same time with numerous authorities, how do you keep track of all of them and not lose any time?

RAPSTAR keeps your department organized and focused.

Getting Product to Market Faster- Track notifications for amendments, declarations of end of trial, and requests for scientific advice.

Faster Interaction Turnaround- Track interactions and expected replies with Authorities.

Regulatory Compliance- Track reporting of serious adverse events, variations to licenses, renewals, and annual reports.

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