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...
Clinical Research IO (CRIO)’s recent site survey showed that most sites have recovered business lost during the pandemic, are adjusting to the decentralized clinical trial model, and have implemented their own software in response. At the beginning of the pandemic, CRIO conducted a survey to look at the impact of coronavirus on research sites. By...
In the latest virtual conference hosted by ACRP, Innovation in the Era of COVID, Raymond Nomizu of Clinical Research IO and Jessica Branning of ClinCloud Clinical Research discussed electronic Source (eSource) and how it has shaped the future of clinical research. Ms. Branning’s site, ClinCloud, was built ground-up on a technological platform centered around CRIO....
The staying power of technology after the pandemic The clinical trials industry has historically been slow to adopt innovation, but 2020 was a catalyst for transformation. Spurred on by the need for business continuity during the pandemic, sites and sponsors worldwide were highly motivated to reconsider business as usual, and many have adopted an array...
We recently passed Crohn’s and Ulcerative Colitis Awareness Week (December 1-7, 2020) and Clinical Research IO was interested in learning more about clinical research in gastroenterology. We connected with Gerry Glazer, Henika Lobo, and Dr. Michael Gould of TDDA Specialty Research (TDDA) to gain insight into conducting GI research. Can you tell us how TDDA...
How did you get into research? I got started in clinical research as an undergrad. There was a group of physicians from Harvard that came to the University of Cincinnati, where I was studying, who started a centralized research office. I was part of that team. The first 2 years I coordinated, and my last...
Creating exceptional clinical research source documents is crucial for successful clinical trials. The best way to ensure that your source documents are ready is to know and understand the Clinical Study Protocol (CSP), which serves as the basis for your source documents. Use the CSP as your primary reference when creating source documents. This is...
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...
Most discussion about electronic source (eSource) documentation in the clinical research enterprise starts from a sponsor standpoint, with eSource being viewed as an extension-almost a mobile version of electronic data capture (EDC). In this view, sponsors provide sites with eSource systems that the sites use to collect data, which are then transmitted to the EDC...
