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Electronic Data Capture EDC

When Designing Clinical Trial Software, Put Your Users First

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  • 20 Jan

What's the best way to design software that your customers will actually enjoy using?

Ask your users.

It sounds obvious enough, but you would be surprised by how infrequently this perspective is taken into consideration when designing clinical trial software.

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For EDCs, Flexibility is Key

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  • 06 Sep

Given the number of data sources that have to be integrated with your electronic data capture system (EDC), it's important to take flexibility into consideration when choosing an EDC. However, some EDCs make integrating with other systems easier than others. Bioclinica's Express EDC was built by data managers for data managers, so we understand how important ease of integration is in an EDC, and we built it with that flexibility in mind.

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Bioclinica Demonstrates EHR to CDASH (E2C) Standard

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  • 06 Jan

Ever since the US FDA introduced Meaningful Use requirements calling for medical practices to begin using EHR systems, the race was on to find a way to pull the data from EHR systems into the EDC systems electronically.  Many options have been tried − most focused on accessing the data from the EHR in the native HL7 format.  While this solution works, it's not easy to do. One of the stumbling blocks is the inability of site personnel to access this type of data from their EHR.

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The Future of Clinical Trial Data Management and Technology's Growing Impact

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  • 22 May
At BioClinica's 2015 Global User Conference, I had the pleasure of leading an expert panel discussion on the future of data management. I would like to share some highlights from my perspective. Panel participants were Daun Bahr, senior director data management Orexigen; Queennette Santiago, head of data management Ultragenyx; Clara Plascencia, associate director of clinical data management Pharmacyclics; and Ann Seibel, clinical data manager BioClinica.
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How Endo Pharmaceuticals Achieved Rapid Study Start Up with a "Killer Collaborative UAT" for EDC

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  • 25 Jun

In my R&D role at Endo Pharmaceuticals, I have seen the lines between operations and clinical data functions becoming more and more blurred. Specialized technical skills are vitally important and they become ever more valuable when the people who possess them come together to work on solutions in a facilitated, collaborative environment.

The Challenge

We presented BioClinica with a challenge in October 2013:

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Primer for Data Managers on 2013 FDA Guidance and Regulations in an Age of eClinical Innovation

Olympic Athletes Model What it Takes for Data Managers to Reach Peak Performance

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  • 24 Feb
We have just witnessed some of the greatest performances of the Sochi Winter Olympics. Behind such epic Olympic moments is a great deal of preparation. Just like an athlete, data managers need the right preparation to reach peak performance.
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Risk-Based Monitoring: What is Your Plan?

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  • 03 Sep

UPDATE: This blog was originally titled “Taking on More Risk by Doing Less Clinical Data Monitoring.” TransCelerate BioPharma, Inc reached out to BioClinica to clarify some points in their methodology. What is important to note is that the TransCelerate approach does not advocate “less monitoring” but rather a shift from an excessive concentration on source data verification to comprehensive risk-driven monitoring.  

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Endpoint Adjudication for Data Managers

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  • 27 Aug

Do you know what the data requirements are for endpoint adjudication and how to ensure quality data? Want to know the pros and cons of paper versus EDC adjudication?

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8 Questions for a Data Management All-Star

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  • 04 Jun
Kathy Yeager, BioClinica’s head of Data Management, is a very busy person. Her team of data managers, data reviewers, clinical coders, quality control associates, and forms designers has worked with over fifty sponsors and CROs in multiple therapeutic areas to provide quality data for their clinical trials. I recently sat down with Kathy to learn more about the importance of data management and how she ensures quality results for our customers.
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5 tips for great eClinical software feature implementation

Get the Features You Want in eClinical and other Software Products

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  • 24 Apr

We have some really cool new features being released in our eClinical software products, such as the launch of our Express EDCplus solution that puts powerful electronic data capture capabilities in the hands of sponsors and CROs. Before joining BioClinica, I had never worked for a software company and I find the process of determining what gets added to the products and what doesn't pretty fascinating.

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Everything you ever Wanted to know About (Determining) Sex in Clinical Trials

Everything you ever Wanted to know About (Determining) Sex in Clinical Trials

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  • 26 Feb

The collection of data associated with sex or gender in a clinical trial isn’t as straightforward as we would initially think. In fact, it’s amazing just how confusing it can be. First off, there is the difference between sex and gender (no, I’m not talking about the differences between men and women, which would be a topic for another blog). According to the Merriam-Webster dictionary:

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Electronic data capture in clinical trials tips

Electronic Data Capture in Clinical Trials and IVR Study Setup Tips

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  • 29 Jan

While they offer sponsors the ability to run faster, more efficient clinical trials, using an Electronic Data Capture (EDC) or an Interactive Voice/Web Response (IVR/IWR) system can be a challenge for any sponsor. Large pharma, small biotechs, CROs, device companies, and academic research centers all go through the same study startup process of determining which data needs to be collected, and how to assure the data is correct and complete.

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Ensure your eClinical technology is FDA compliant

Top 10 Ways to Ensure Your eClinical Technology is FDA Compliant

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  • 03 Jan

Keeping up with FDA requirements can be a full time job. There are several FDA guidances related to using eClinical technology in clinical trials with two released this year alone. I recently conducted a webinar that focused on this topic which included a list of ways to ensure your eClinical technology is FDA compliant. The list appears below.

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Powerful Clinical Apps

Windows 8 and Surface Tablet Pave the Way for Powerful Clinical Apps

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  • 21 Jun

The internet is buzzing over the news that Microsoft is entering the tablet market. Anyone who follows such things knew that Windows 8 would have touch interface designed for tablets, but few were expecting Microsoft to produce its own hardware to run it. Since BioClinica is a Microsoft Life Science Gold Certified partner our developers have been running Windows 8 on tablets for the past few months. I can’t wait to get my hands on one! I really like that the Windows OS on the slate is the same as on the PC so I am not limited to running only ‘tablet based’ clinical apps.

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BioCure Monitoring Trip Report

Site Monitoring Goes High Tech with On and Off Line CTMS Forms

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  • 20 Apr

Do you still carry a briefcase full of paper? Are you lost without an internet connection? Hopefully, you have embraced technology and answered "No" and "Yes" to those questions.

Here in 2012, most clinical studies use electronic data collection (EDC). The use of Clinical Trial Management Systems (CTMS) to perform site management and keep track of study regulatory documents, monitoring visits and study budgets has been significantly on the rise over the past few years. Using paper envelopes to randomize is almost extinct and study monitors are finally ready to part with their big suitcase of highlighters, black pens, 3-part NCR forms, and yellow sticky notes.

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Bioclinica is organized into three business segments so that we can provide expert service and multifaceted technologies. Our Medical Imaging & Biomarkers segment includes an Imaging Core Lab, a Cardiovascular Safety division, and a Molecular Marker Laboratory. Our eHealth segment comprises eClinical Solutions, Randomization & Trial Supply Management, Safety & Regulatory Solutions, and Financial Lifecycle Solutions. Under the Global Clinical Research segment, we offer a network of research sites, patient recruitment, and a Post-Approval Research division.

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