Progress notes are free-text entries by the investigator, coordinator or study team member that are inserted into the source record. Generally, these play a critical and highly undervalued role in the study process. Progress notes are often used to: Clarify or confirm any data points that may appear as outliers, even before a query is...
Running a Study
Getting a new product to market is expensive. There are a variety of studies and research that point to a wide array of costs, but generally speaking, it costs nearly $3 billion dollars to bring a new drug to market. Yes, you read that correctly. Beyond this, the success rate of a new compound to...
Running a Study
The highly anticipated Decentralized Clinical Trials (DCT) draft guidance from the FDA was finally released on 02-May-2023. In this 19-page document, the FDA outlines its current thinking around the concept of DCTs. From the outset of the draft guidance, the FDA makes a clear point on what DCTs can mean for patients and the patient...
Running a Study
The new standard in clinical care Electronic Medical Records In the past several decades, Electronic Medical Records (EMR) have become standard in clinical care in the United States and many other countries, while Electronic Data Capture (EDC) systems have become standard in global pharmaceutical trials. Naturally, the industry has been highly focused on the tantalizing...
Running a Study
Note: As of this writing, CRIO’s Reviewer model (eSource/EDC) is live in several studies; early indications are that the new operating model saves sponsors and CROs significant monitoring time. In this post, we outline the current CRA time allocation as a baseline, then model how our innovative approach can cut that time in half. ...
Running a Study
Why use EDC if eSource has the endpoint data? In the CRIO article, Automate the protocol with eSource, we described how CRIO eSource automates the protocol, building compliance at the point of capture. CRIO is often asked if we can send the data to the EDC. The answer is yes, if the EDC system’s API...
Hiding in plain sight – CRIO eSource is the biggest opportunity for sponsors. While the clinical research industry has automated many processes, there is one area that is still mostly paper-bound. This is the source of one of the greatest inefficiencies in research today. Automating this one process could drive 20% cost savings in a...
Recruitment & Diversity
The new FDA guidance to enhance diversity in clinical research subjects has brought ethnic and racial diversity to the center stage for sponsors. In this document, the FDA encourages sponsors to develop a Race and Ethnic Diversity Plan to incorporate into each protocol. More specifically, the FDA suggests that to achieve these diversity targets, sponsors...
Recruitment & Diversity
Enrollment is critical to a trial, and site performance is a major – if not the most important – driver of that. We’ve always known that our full stack system enables sites to increase efficiency and enhance data quality, but do sites who use CRIO actually enroll more? We now have data to prove that...
Running a Study
CRIO’s integrated eSource-EDC model revolutionizes both the data entry process at the site level and the monitoring process from the CRO perspective. According to a third party survey of CRAs who have used CRIO, CRAs agreed by a margin of 23:1 that this new model would increase overall trial efficiency, improve data quality, and enhance...
Running a Study
Over 13,000 protocols have gone through the CRIO system, and in the vast majority of them, CRAs have used CRIO to monitor source. We’ve always heard from our sites that their CRAs love the system, but now we have proof. According to a third party survey of CRAs who have used CRIO, by a healthy...
Running a Study
The daunting task of COVID-19 trials The onset of the COVID-19 pandemic posed a new challenge for sponsors. They needed to execute clinical trials at a rate that has never been accomplished before. To succeed, they needed sites that could conduct the trials at unprecedented speed. These are sites with short start-up times, existing large...
