Mary Brenner, MSN MArch RN, is CRIO’s Study Design Manager and brings deep-rooted expertise as a registered nurse to CRIO’s in-house study design team. In this quick Q&A, Mary shares the benefits of good study design for sponsors and sites, the downstream effects of standardized study designs, and gives tips for designing it on your...
Mark Joing is the Founder & CEO at Mojo Trials, a startup life sciences service provider delivering virtual site monitoring in clinical trials. He is also the Chief Operating and Financial Officer at Sanaby Health, a Special Purpose Acquisition Company created to accelerate innovation in healthcare. His 25+ year career in biopharma includes executive roles...
Bridging the gap eSource is the bridge between the protocol and the eCRF fields. To understand why, we need to understand what each does. The protocol describes the purpose of the study, the core hypotheses, the endpoints that are to be collected, and the resulting procedures to be performed to support those endpoints. The eCRF...
73% of sites reported using paper as the primary means of data collection In a 2018 CRIO site survey with over 100 respondents, sites reported that they use their Electronic Medical Record (EMR) primarily for patient recruitment purposes, but not for source data collection. 62% of site respondents reported that they use the EMR as...
How did you get into clinical research? During medical school, I completed several research externships and became very interested in research, but did not think of it as a career. After graduating and moving to Florida for residency, I met a local physician who was a principal investigator and owned a clinical research site. We...
Striving for site success and business continuity amidst our global pandemic? Virtual monitoring bypasses the need for travel, made nearly impossible with the coronavirus, and becomes a critical technological solution for the kind of business continuity that keeps the industry reliable and strong. You can turn complexity into meaningful change. In this webinar, Raymond Nomizu,...
Since Clinical Research IO first visited Cytel’s COVID trial tracker in April 2020, the number of treatment and vaccine trials has almost tripled. To date, there are 1,751 COVID studies. Given that the speed of protocol design and study start up has drastically increased throughout the pandemic, we can expect this number to continue rising....
Electronic Source (eSource) and Electronic Data Capture (EDC) are increasingly popular technologies for collecting and managing clinical trial data. The two types of systems are less similar than their names suggest. Interested in learning more about eSource? See why Clinical Research IO’s system is leading the industry by requesting a demo of our software.
Disclaimer: The examples noted in the following article are all firsthand accounts of the author, but for the purpose of this article have been combined into a single site visit. The visit depicted below is an aggregate of many sites and studies and is not necessarily an exact representation. The original version was written entirely...
Most clinical trials are conducted with onsite monitoring, where a clinical research assistant (CRA) visits the site to perform source data verification, drug accountability, and other review functions. As COVID has imposed significant travel restrictions and stay at home mandates, many CRAs cannot currently perform on-site visits; even if they could, many of their sites...
Over the past four months, COVID has led to widespread changes across the clinical research industry, many of which will be carried forwards. 1. Changes in Clinical Trial Protocol & Design According to data collected by the Tufts Center for the Study of Drug Development (CSDD), as of May 20, 2020, more than half of...
It is no secret that CRA turnover is a huge issue in the clinical research industry. It is not uncommon for sponsors or CROs to spend thousands of dollars onboarding a CRA, only to have them leave within one to two years after starting. Recent reports from the ACRP1 show that CRA turnover rates were as...
