Addressing Safety in Phase I Clinical Trials

The purpose of conducting 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 be sure that each drug or device that is being tested is safe before moving forward with the next phase. Unfortunately, it is also at this point that many studies fail, as only 30% of Phase I studies make it to Phase II. In general, 90% of treatments never make it to the FDA approval process.1 In order to mitigate safety risks, studies should incorporate the use of CDISC standards, have an adaptive study design and risk-based approach, and implement Electronic Data Capture (EDC).2

Adopting new technology, like EDC, leads to fewer errors and results in higher quality data.   Medrio’s m1 product was made specifically with Early Phase and Phase I clinical trials in mind and provides a variety of solutions to help avoid costly and time consuming trial hazards. Some of the safety features that are found in m1 are edit checks, queries and alerts, and real time reporting. All of Medrio’s CloudEDC™ products are fully compliant with 21 CFR Part 11, Annex 11, EU Safe harbor, Good Clinical Practice, thus eliminating any regulatory risks.
m1’s safety features include…


Configurable & Automatic Edit Checks

Medrio’s m1 software ensures that data is entered correctly and provides a visual indication when unexpected data is entered.  Using m1, you can minimize queries with range checks upon data entry with our real-time edit check tool and define the normal data range for your study. If there are any out-of-range variables, a warning will appear to make sure the data is corrected.


Queries and Alerts

Automatic and customizable queries are another way that m1 helps to increase study safety. You can easily configure a query to fire without programming if a protocol deviation occurs. Alerts can be easily set to fire when a serious adverse event occurs, ensuring that all study managers are aware of any unexpected or unwanted occurrences.


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 Serious Adverse Events (SAEs). All users have the ability to monitor data remotely and evaluate patient safety with just one click.


Get a Free Trial

These measures not only help to efficiently manage your study, but also to ensure the safest treatment of your subjects. Schedule a demo today and learn more about why m1 is the right choice for your Phase I trial!
Sign up today at www.medrio.com/free_trial.


1 “The Drug Development and Approval Process.” FDAReview.org. FDAReview.org, n.d. Web. 10 Nov. 2015. http://www.fdareview.org/approval_process.shtml.
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. https://advancedclinical.wordpress.com/2010/07/11/advancing-discoveries-regulatory-and-risk-decisions-in-adaptive-designs.

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