Between loads of emails and back-to-back patients, the clinical research super-coordinator swiftly and accurately manages your site’s data collection, leaving you with peace of mind at the end of a long day. One can only imagine what might happen without a super-coordinator by your side…the horror! Unfortunately, it’s more common than many site owners would...
With trial activities ramping up at both the site and sponsor levels, it is inevitable that the amount of work for sites will increase. In preparation, sites should start thinking about how to bring back site staff and how work should be distributed amongst them. One great option that sites can consider is developing a...
CRIO reviewed the websites of 49 large clinical research sites and site networks (identified from public literature searches and CRIO’s own database) to review whether they’ve posted public information about their response to the pandemic. Of the 40, 17 did. Of the 17, 7 happen to be CRIO clients. Here is a summary and several...
Though Electronic Source (eSource) has been around for 10 years, it’s only recently started to gain momentum among clinical research sites. Why is now the perfect time for eSource adoption? This article, written by CRIO co-founder Raymond Nomizu, explains why eSource makes sense today. Introduction to Electronic Source For Clinical Trial Sites Electronic Source,...
Hear what it feels like to endure an FDA audit as a Principal Investigator or clinical research site owner, based on interviews with current or former site owners and operators. Stage 1 of an FDA Audit: Anticipation One mistake could ruin your clinical trial site… Unfortunately, many site owners and principal investigators live in constant...
At Clinical Research IO we work with thousands of clinical research professionals, such as clinical research coordinators, each day. As a CRIO Project Manager, I am fortunate enough to have the opportunity to develop one-on-one relationships with my clients — relationships that are more than just your typical software vendor-customer contracts. I spend a lot of...
If advertising your clinical trial for patient recruitment is tough for your research site, you aren’t alone. According to the National Institute of Health, among U.S. investigators participating in a clinical trial, “75% of investigators fail to enroll the target number of subjects.” This issue could spell trouble for you, translating to less revenue and...
Good Clinical Practices (GCP) requires that “essential documents” be filed at the sponsor and investigative sites in a timely manner. While the sponsor is responsible for establishing a Trial Master File (TMF), the site is responsible for the Investigator Site File (ISF), which many call the Regulatory Binder. A key part of creating a plan for...
To continue operating throughout the pandemic, research sites quickly implemented a variety of measures and procedures (i.e., PPE requirements, increased sanitation, COVID screening, IP handling systems, patient transportation systems, limitations on number of people on site, etc.). While these measures continue to be necessary, they have increased site workload and consequently led to an unprecedented level of financial strain....
The impact of COVID-19 on clinical trials has likely become obvious for your site during this phase of the pandemic. Sites are struggling with screening holds, limited staff, an influx of sponsor requests while staff is not on-site, the challenge of retaining enrolled subjects, and more. It is now more important than ever to implement a business...
At the end of March 2020, Clinical SCORE conducted an online survey to gain insight on how the pandemic is affecting clinical research sites across the world. As the crisis is still evolving, the company conducted a similar questionnaire at the beginning of May to obtain a more updated picture of clinical trial sites and to compare...
Coronavirus is disrupting clinical research at sites worldwide. To further understand how COVID is affecting research at a site level, CRIO connected with Dr. Marcus Stone, the Director of Clinical Research at The Spine Institute of Louisiana Foundation, the research arm of a broader spine institute. The Foundation was created solely to identify and test...
