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CRIO Company News 1 Minute Read

JSCDM: Comparison of electronic health records and electronic source data in clinical research trials

The Journal of the Society for Clinical Data Management (JSCDM) recently published the original research article “Comparison of electronic health records and electronic source data in clinical research trials: a retrospective review” which was co-authored by Amelia Tian, CRIO Solutions Consultant, and Olivia Dennis, CRIO Analytics and Data Migration Manager, alongside Dr. Elena Christofides (Endocrinology...

21 cfr compliance update
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...

eSource vs EDC what's the difference
Running a Study
7 Minute Read -

eSource vs EDC – What’s the Difference?

What is eSource? According to the FDA, eSource is defined as “data initially recorded in electronic format. They can include information in original records and certified copies of original records of clinical findings, observations, or other activities captured prior to or during a clinical investigation used for reconstructing and evaluating the investigation.” eSource is already...

Data Management to Data Science - It’s Time!
Running a Study
8 Minute Read -

Data Management to Data Science – It’s Time!

Over 70% of clinical trial data today comes from non-case report form data. Non-case report form data includes continuous data such as wearable data, lab data, patient reported data and ECG data, to name a few. Generally speaking, these are all collected as source without transcription or entry into another system. Today, we have reached...

Progress notes are vital to source data
Running a Study 5 Minute Read

Progress Notes are Vital to Source Data

Progress notes are free-text entries by the investigator, coordinator or study team member that are inserted into the source record. Generally, these play a critical and highly undervalued role in the study process. Progress notes are often used to: Clarify or confirm any data points that may appear as outliers, even before a query is...

Hand of businessman using smart phone with coin icon, technology, clinical trials operations
Running a Study
5 Minute Read -

Sponsors, Funding is Tight – Be Smart with Your Money

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...

DCT Draft Guidance explained
Running a Study
8 Minute Read -

The FDA’s Decentralized Clinical Trials Draft Guidance Explained

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's 2022 CRA Survey Summary
Running a Study
1 Minute Read -

CRIO’s 2022 Clinical Research Associate Survey Summary

The clinical research industry made big changes to adapt to the operational disruptions of a global pandemic. Today, it’s more exciting and diverse than ever before. With the high level of technology adoption to enable the continuity of clinical trials, CRIO wanted to learn more about CRA  experiences using the CRIO platform, the leader in eSource technology. CRIO retained...

Running a Study
7 Minute Read -

How Monitors Spend Their Time, And How That Can Be Cut In Half

Note: As of this writing, CRIO’s Reviewer EDCmodel (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. Clinical...

How eSource replaces the EDC
Running a Study
7 Minute Read -

How eSource Replaces the EDC

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...

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