Addressing Safety in Phase I

The purpose of a Phase I trial is to test a new drug or treatment on human subjects for the first time in order to determine its safety, evaluate side effects, and ascertain the correct dosage level. It is important to ensure that each drug or device being tested is safe before moving forward with the next phase. Unfortunately, it is also at this point that many studies fail; only 30% of Phase I studies make it to Phase II. In general, 90% of treatments never make it to FDA approval1. To mitigate safety risks, there are numerous steps researchers take. These include adhering to CDISC standards, using adaptive study designs, and implementing Electronic Data Capture (EDC)2.

Adopting tools like EDC with real-time edit checks leads to fewer errors and results in higher quality data. Though Medrio is a trusted EDC across all study phases, the software has become an industry leader in Phase I data management, and is therefore equipped not only to help keep study costs and timelines down, but to offer solutions with a particularly strong focus on patient safety. Some of the safety features available in the software are edit checks, queries and alerts, real time reporting, and, perhaps most importantly, the ability to set alerts to fire when a Serious Adverse Event (SAE) occurs. These features alert researchers to data errors as quickly as possible, drastically reducing the possibility of patient dosing continuing based on false data. All of Medrio’s cloud-hosted products are fully compliant with 21 CFR Part 11, Annex 11, EU Privacy Shield, and Good Clinical Practice, thus mitigating any regulatory risks.

Here’s some more info on how Medrio protects patient safety:

Configurable & Automatic Edit Checks

Medrio ensures that data is entered correctly and provides a visual indication when unexpected data is entered. Users can minimize queries by defining data ranges. If there are any out-of-range entries, a warning will appear to make sure the data is corrected.

Queries and Alerts

Automatic and customizable queries are another way Medrio helps to ensure patient safety. Without any required programming, users can configure a query to fire if a protocol deviation occurs.

Accessible Reporting in Real Time

Medrio provides reports to monitor your study’s progress and give you a real-time overview of your data, including any SAEs. All users have the ability to monitor data remotely and evaluate patient safety with just one click.

Get a Free Trial

In an industry as highly regulated as clinical research, patient safety is paramount. Researchers conducting Phase I trials need as much assurance as possible that any risk to the safety of the subjects in their clinics will be minimized and acted upon without delay. Medrio offers this assurance, as well as the speed and efficiency that are the primary appeals of EDC. Schedule a demo to see the impact Medrio can have on your trials in Phase I and beyond.

1 “The Drug Development and Approval Process.” FDAReview.org. FDAReview.org, n.d. Web. 10 Nov. 2015. .
2 Brown Safford, Paula, and Andrew Garrett. “Advancing Discoveries: Regulatory and Risk Decisions in Adaptive Designs.” Advanced Clinicals Blog. Quintiles, 11 July 2010. Web. 10 Nov. 2015.

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