Industry knowledge, webinars and more for clinical research sites
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The highly anticipated Decentralized Clinical Trials (DCT) draft guidance from the FDA was finally released on 02-May-2023.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 From the outset of the draft guidance, the FDA makes a clear point on what DCTs can mean for patients and the patient...
CRIO Culture
CRIO’s mission statement serves as our north star. It shapes our strategy and prioritizes our initiatives. Developed by the CRIO management team, it encapsulates succinctly what makes us different, and it avoids buzzwords and vague, unattainable aspirations. Our mission is “To design and deliver a modern, intuitive, and integrated software platform that reimagines clinical trials...
CRIO Culture
The Challenge How do remote organizations ensure their team members are performing? We’ve heard it all. Webcam monitoring, mouse movement, activity tracking, micromanagement. But what if we told you CRIO does none of this. Yet, we consistently develop and retain some of the top talent in the industry? Here’s our secret. Traditionally, performance reviews were...
CRIO Culture
With its increasing popularity, remote work comes with a wide array of benefits centering around flexibility and cohesion with the human element of our workforce. It has also moved the needle for ways we think about productivity and talent development – namely, virtual learning. There are skeptics who believe that remote work impedes career development...
Running a Site
Kristen Bosse, Director of Product Development, is CRIO’s in-house product guru. In this Ask Me Anything, a CRIO expert roundup, Kristen discusses CRIO’s products, UX design and beta testing, and shares recommendations for sponsors looking to identify the best sites for their trials. What differentiates CRIO’s products from any other products on the market? We...
eConsent: The Benefits With the recent push toward Decentralized Clinical Trials, many sponsors are adopting eConsent. eConsent allows patients to consent electronically, whether in clinic or remotely, from the convenience of their home. eConsent offers sponsors, CROs investigators and patients these benefits: Removal of errors by ensuring completion of all fields Accuracy of date-times through...
Running a Site
Jonathan Andrus, President & COO at CRIO, is an active thought-leader and presenter in the life sciences industry. He serves on the board and executive committee of the Society for Clinical Data Management (SCDM) and is co-lead with the Decentralized Trials and Research Alliance (DTRA) workstream initiative. The year was 1996 – the year that...
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...
Running a Study
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...
