The clinical trials industry is undergoing rapid change. Medical breakthroughs are being made at an unprecedented rate and the number of investigational drugs being tested in clinical trials has more than doubled since 2000. However, the regulatory landscape has not kept pace with this growth. Some areas of regulation have become so complex that they’re nearly impossible to navigate without specialized expertise—which is where eRegulatory comes in. eRegulatory supports quality and compliance in a way that paper-based processes never could.
When you are working on a clinical trial, there are many different parties involved in the process. From the sponsor to the CRO to the investigator and more, communication between all of these parties is crucial for ensuring a smooth and effective process.
eRegulatory can help improve communication in two ways: by providing an efficient way for everyone to communicate and by allowing for better tracking of all communications.
In order for communication between all parties involved with a clinical trial to be effective and efficient, it must be done in real time or as close to real time as possible. This ensures that nothing gets lost along the way, which could lead to costly mistakes later down the line when it comes time for analysis or reporting on results from testing.
Increase Visibility into Study Progress
To enhance visibility into study progress, eRegulatory allows you to see the status of all studies, sites, and investigators. You can access and download documents at any time—without having to wait for hard copies in the mail. With eRegulatory, you will also have access to an integrated central database where documents can be stored and made available electronically.
Reduce Risk with Better Oversight and Tracking
eRegulatory is a way to organize all the information related to your clinical trials. It makes it easier to monitor and track your studies, because eRegulatory keeps all the information in one place. This includes documents that you may have received from CROs and other vendors, as well as documents sent back by regulators. eRegulatory can also help identify risks early on so that you can take action before they become problems later on down the line when it comes time for an inspection or audit by regulators.
So what does this mean? Not only are there fewer risks from mistakes made during data entry, but there are also fewer errors overall (which means less work for you). If any fraudulent activity happens at any point along the way during a study, such as not filing reports correctly or falsifying data, you’ll be able to catch it sooner rather than later!
Enhance Data Integrity and Transparency Across the Board
As a secure platform, eRegulatory helps to ensure data integrity and transparency across the board. It is a single source of truth for all stakeholders and all stages of clinical trials—from initial submission through post-approval monitoring.
eRegulatory’s unique “iWatch” feature allows you to monitor the lifecycle of your study throughout its entire duration. By providing an overview of all documents associated with your study, it gives you complete visibility over where everything stands at any given moment in time. This ensures that any problems can be quickly identified and addressed in a timely manner, so there are no delays in sending out consents, enrolling participants into trials on time, or meeting timelines necessary for regulatory approval.
As we’ve seen, eRegulatory can improve quality and compliance in clinical trials with a range of benefits. It improves productivity by automating forms and other time-consuming tasks, while also reducing the risk of human error. The technology also makes communication easier so that you have more visibility into your study progress. And finally, eRegulatory offers better oversight and tracking capabilities than traditional paper-based processes ever could!