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Jennifer Price's blog

2016 CDISC International Interchange: Standards, Metadata and the FDA

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  • 13 Oct

The last week of September, I had the opportunity to be a chair on the EHR/MDR session at the 2016 CDISC International Interchange in Maryland. I always enjoy being involved with the CDISC Interchange; it is inspiring to see all the people who are passionate about submitting quality standardized data to the FDA to make better lives for us all.

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CDISC eSource Stakeholders Plan to Supply Pharma with Path Forward for Collection of EHR and Other eSource Data

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  • 11 Jul

CDISC held an eSource stakeholders meeting on March 18, 2016 during the CDISC interchange in Silver Spring, MD. The initial invitation said "During this initial meeting, we plan to discuss the charter and plans for this group as well as introduce members to each other and update the group on recent work."

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CDISC

CDISC Public Courses in Audubon, March 2-12: Register with CDISC today!

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  • 04 Feb

Here's a great opportunity to learn CDISC from CDISC at Public Courses being held in Audubon, Pennsylvania at Bioclinica's eHealth Headquarters on March 2-12. (Other dates and locations are available).

Why take CDISC Training?

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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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What’s New with CDISC Standards?

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  • 16 Dec

Progress on CDISC Standards has come at a quickened pace in recent years. Helping make advancement of industry-wide standards possible is collaboration among CDISC and other participating organizations (Critical Path Institute, Association of Clinical Research Organizations, Innovative Medicines Initiative, and National Cancer Institute). Joining in the collaboration are regulatory authorities and the pharma industry itself, as well as TransCelerate Biopharma which continues to press forward with its standards initiative.

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eSource: Are You On-Trend with Other Sponsors?

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  • 12 Nov

eSource is a topic that has everyone talking and it continues to dominate the conversation at industry gatherings, including the annual SCDM conference held earlier this fall. From what I heard there − and continue to hear – sponsors' experience with eSource runs the full gamut.

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eSource: Still in the Shallow End of the Pool?

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  • 23 Oct

Dipping a toe in the water is always easier than jumping right into something new.

I am reminded of this old axiom as I look back at the recent SCDM conference and see it holds true for eSource.

Testing different eSource modalities within a controlled environment is one way to get acclimated and explore the use of eSource in your clinical trials while building experience – all in a low-risk way. Beginning with data that's directly entered as eSource is a whole lot easier and safer than attempting to hit it 100 percent from the high dive on the first try.

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7 Principles of eSource Use

7 Principles of eSource Use

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  • 17 Oct

As I write this, I’m on a return flight home to Philadelphia from Las Vegas where I attended the Annual SCDM conference. It was a great event and I’m pretty revved up to share what I saw and heard there, especially on the evolving topic of eSource.

One session I’d like to tell you about is an eSource roundtable that was moderated by Linda King, Director of Global Data Delivery at Eli Lilly and Demetris Zambas, VP and Global Head, Data Management at Novartis. Representatives from CDISC, Merck, J&J, AssisTek, Quintiles, and Otsuka rounded out the expert panel.

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Make clinical trial management faster and easier

Clinical Trial Management: If I Only Knew Then What I Know Now

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  • 06 Feb

Can we make our data collection faster and easier? Will the right treatments be onsite when it's time to randomize? How can we be certain that problems identified at sites are being resolved?

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eClinical in 2014 – What’s Trending Right Now?

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  • 08 Jan

Daily interactions with Sponsors took the BioClinica team around the globe, from Boston to Utah and Belgium to Israel in 2013, where we observed some interesting trends. Last year — more so than any other in recent history — marked significant change in what customers want from their eClinical systems.

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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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DIA 2013 Boston Recap

DIA 2013 Boston Recap from the BioClinica Exhibit

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  • 10 Jul
As Director of Clinical Solutions, one of my responsibilities is giving product demonstrations in BioClinica’s exhibit booth. Much of my time during conference hours was spent with my eyes and ears focused on growing my understanding of your needs to run clinical trials more efficiently and cost-effectively. Below is a recap of hot topics from my vantage in the exhibit hall point where thousands of industry professionals converged to learn new ways to overcome current and future challenges:
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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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What semantic web standards can do for clinical research

What the Heck are Semantic Web Standards?

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  • 22 May

A Semantic Model is defined as a conceptual data model in which the model describes the meaning of its instances.  This is a HOT topic when we are talking about web standards.  Being able to describe the metadata in an electronic re-useable way opens up a lot of opportunities for better quality and control.

Kerstin Forsberg is an expert in Semantic Models currently working at AstraZeneca. She has 25+ years of experience in information and knowledge management strategies, standards and solutions across the pharmaceutical, news and automotive sectors.

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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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Join Bioclinica's Justin Hunt on Nov. 28 in a live webinar! Find out how to overcome common hurdles in CTMS impleme… https://t.co/wHfWHtI7sj
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Another CRO seeing big gains in the sites payments process! Access the Case Study here https://t.co/jsCxhmKcLo https://t.co/LpIKEtBKtE
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Great advice from our Dir. Cardiovascular Imaging on quality imaging acquisitions & assessments in clin trials. https://t.co/OVH7pZ3SL0
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