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Running a Site 5 Minute Read

21 CFR Part 11 Regulation Compliance Update

Compliance Update:  The 21 CFR Part 11 Regulation is a cornerstone of conducting clinical trials in today’s world.  The release of the regulation 1997 established guidelines for the use of electronic records and electronic signatures in FDA-regulated industries and had a significant impact on the pharmaceutical and medical device industries. The FDA began working on...

The Current State of Clinical Trials in Ukraine—A Conversation with Dr. Roman Fishchuk
Running a Site
4 Minute Read -

The Current State of Clinical Trials in Ukraine—A Conversation with Dr. Roman Fishchuk

Meet Dr. Roman Fishchuk, an esteemed otorhinolaryngologist (ENT) whose journey in the healthcare field has been marked by a commitment to providing medical care and innovative treatment options through clinical trials in his native Ukraine. Having graduated from Ivano-Frankivsk National Medical University, Dr. Fishchuk specialized in otolaryngology and completed a Master’s degree at the University...

Geting Ready for Data Migration with CRIO
Running a Site
3 Minute Read -

Transitioning to CRIO? How to Get Your Data Ready for Migration

You have just signed on to use CRIO and you are excited to get started. Even if you are moving primarily from paper, you may have data that you want to migrate into CRIO rather than having to re-enter it. For many of our new clients, they have a wealth of information available in spreadsheets...

get started with CRIO medical records API in 6 easy steps
Running a Site
2 Minute Read -

Getting Started with the CRIO Medical Records API in 6 Easy Steps

It’s easy to get started with CRIO’s Medical Records API with these 6 steps. This blog post will help you set up and be ready to go in just over an hour. If you haven’t already signed up for the Medical Records API, click here for more information, reach out to your customer success representative,...

The Patient Safety Impact of Medical Record Delays in Clinical Trials
Running a Site
2 Minute Read -

The Patient Safety Impact of Medical Record Delays in Clinical Trials

In clinical trials, patient safety is paramount. Once a subject is randomized into a clinical trial, they undergo a series of treatment procedures. Any changes in their medical status, including alterations in medication or occurrence of Adverse Events (“AEs”), need to be recorded. These changes are typically noted by site staff in a document known...

Addressing the Challenge of Inaccurate and Incomplete EHRs in Clinical Research
Running a Site
2 Minute Read -

Addressing the Challenge of Inaccurate and Incomplete EHRs in Clinical Research

In our previous blog post, “Navigating Medical Records Acquisition in Clinical Trials,” we unpacked our solution for the time consuming process of sourcing patient medical records. In this followup, we’re addressing the challenge of inaccurate and incomplete EHRs in clinical research. Electronic Health Records (EHRs) form the backbone of healthcare data. However, when it comes...

Running a Site 2 Minute Read

Navigating Medical Records Acquisition in Clinical Trials

Navigating medical records acquisition in clinical trials is a time consuming challenge faced by clinical research sites. Electronic Health Record (EHR) systems play an integral part in this process, serving as critical repositories of patient data. Yet, the lengthy process required to access these records often complicates the patient screening process. Subsequently, this impacts enrollment...

Running a Site
8 Minute Read -

Why sites and sponsors need a Medical Records API

EMR Integration: The Challenge In the past several decades, Electronic Medical Record (EMR) systems have become the standard in documenting 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 possibility of...

Site Autonomy - Choose Your Own eSource Tool
Running a Site
5 Minute Read -

Site Autonomy – Choose Your Own eSource Tool

Thousands of sites around the world have embraced site-facing tools such as eSource, eISF, and eConsent. These technologies are now a routine part of the clinical trials landscape. Yet, we still often hear sites expressing their belief that they need sponsor approval to adopt their preferred electronic source platforms, like CRIO eSource. That is simply...

Improving patient diversity with technology
Recruitment & Diversity
3 Minute Read -

Improving Patient Diversity in Clinical Trials with Technology

Improving patient diversity in clinical trials has been a major initiative by the FDA as evidenced by the 2020 Enhancing the Diversity of Clinical Trial Populations guidance as well as the 2022 Diversity Plans guidance. Many forward-thinking site operators are looking for new ways to access potential study participants that better reflect the population most likely...

Running a Site
2 Minute Read -

Ask Me Anything – Tools for Top Performing Sites

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...

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