Document Exchange

The Regulatory Document Exchange™ (RDX) is a fully automated workflow system for the distribution, tracking, and collection of clinical site documentation. The RDX offers more document accuracy with less administrative burden. Learn more about safety document distribution software to see if it is the right option for your clinical operations team.

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Safety Document Distribution Software

 

RDX offers many benefits as a safety document distribution solution. Administrators can easily sort documents and assign users. Users can quickly get access to the information they need when reviewing studies. Using the software helps to ensure a study remains in compliance from start to finish. The software also helps clinical trial teams efficiently prepare for inspections with FDA investigators.

Organization Made Easy
I know exactly where to look for study documents by protocol, no more wasted time. - Investigator Site

BENEFITS OF DOCUMENT EXCHANGE

BENEFITS OF DOCUMENT EXCHANGE

After the initial notification, users can gain access to the Regulatory Document Exchange quickly. Configuration takes about two business days. Admins can upload and send documents immediately for site activation.
Once uploaded, each document is color-coded and assigned a status, allowing the user to watch its progress. Document statuses include:
- Browsed
- Awaiting Response
- Pending Action
- Approved
- Rejected/Returned
Users can easily access the RDX from their general InvestigatorSpace account after they select the designated study to view. Once a user chooses a study, they can view assigned documents by site.
The transaction log report displays the history of a document, detailing any action taken. The log file includes document and transaction details, such as the date, submission version, user, transaction and notes.
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Compliance for Regulatory Approvals

 

RDX helps ensure that a study complies with all regulations, such as Part 11 of the Code of Federal Regulations Title 21. Compliance is essential for regulatory approvals and for the trial to proceed.

 

During a clinical trial, there is a chance that inspectors from the FDA could come on-site to perform an investigation. The purpose of on-site investigations or inspections is to monitor the conduct of the study, its data and reporting practices. An investigator from the FDA usually has several goals when conducting an inspection. They are looking to make sure the study:

 

  • Protects the rights of its subjects.
  • Complies with regulations.
  • Submits reliable and accurate data for marketing or research purposes.

 

As inspections may be unannounced, it’s imperative the teams conducting clinical trials have an easy way to access and organize their documents. During the inspection, an investigator might request the following:

 

  • Proof that trial investigators have completed good clinical practice (GCP) training
  • Reports or documentation of adverse events that occurred during the trial

 

Safety document distribution software organizes the documentation that may be required during an inspection. Research personnel can quickly pull up the documents the investigator requests at the beginning of an inspection. Providing the investigator with the information and documentation requested can help increase the likelihood of passing the inspection. Document exchange software can also make it easier to correct any deficiencies the investigator may discover and improve the process of responding to warnings issued by the FDA.