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CDISC

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

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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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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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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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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FDA and pharma clinical data exchange standards

Clinical Data Exchange Standards between FDA and Pharma Industry

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  • 06 Nov

The FDA recently organized a meeting to discuss clinical data exchange standards between the FDA and the pharmaceutical industry. There were speakers from the FDA, pharma, and technology vendors. The good news is the FDA is receiving data in Study Data Tabulation Model (SDTM) format, although currently they only receive 35% of the data this way.

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EDC in Clinical Trials

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  • 29 Mar

What do companies want to know when selecting an EDC solution? As a BioClinica eClinical product demonstrator, I meet a lot of sponsors and CROs looking for an Electronic Data Capture (EDC) product to support their clinical trials. EDC systems have become an integral part of the clinical trial process, so most companies I encounter have used them before. Some want to see all the options before selecting a vendor, others are unhappy with the vendor they have been using and are ready for a change, and a few have never used EDC in clinical trials and are starting from scratch.

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What Should be the Next Great CDISC Standard?

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  • 26 Sep

I was listening to an Adam Carolla podcast this morning, and he was talking about coffee. His discussion about coffee prompted me to start a comparison to CDISC standards. Adam thought that the federal government should mandate coffee makers to all have the feature that stops the drip process when the pot is removed, allowing us all that first cup without making a mess. This line of thought prompted Adam to wish for a mandate on beer bottle caps. Shouldn’t they all be twist off? Why do we have both twist off and pry off tops?

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FDA Points Out Few Whoops Moments Regarding CDISC SDTM Submission Data

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  • 18 May
It looks like the FDA wants CDISC SDTM data but is getting frustrated with sponsors not adhering to the guidelines and not checking their data. Their recent document 'CDER Common Data Standards Issues Document Version 1.0/May 2011' is basically a hand slapping finger-wagging confrontation indicating what not to do when submitting CDISC SDTM standard datasets. Along with recommendations such as simply reading the manual, or in this case, reviewing and adhering to the standard where possible, there are some insights to the problems the FDA has seen with CDISC submission data. Some of these are subtle, but some are just plain embarrassing!
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CDISC Interchange Meeting 2011 Notes and Highlights

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  • 20 Apr
Belgium beer, waffles, chocolate and CDISC are absolutely some of my favorite things experienced at the CDISC Interchange meeting last week. Below are some of my notes, thoughts and observations from the meeting. I wanted to get this out while the information is still hot. If you want any more details on any particular CDISC topic, please leave me a comment and I will do my best to provide them.
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Using CDISC Standards in an EDC Study

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  • 10 Mar
According to a recent EDC study, CDISC standards have completely changed the way data is collected in EDC studies, yet the adoption process can still be painstakingly long. By setting up an EDC study using CDISC standards, you will reduce the amount of queries generated, improve data quality and reduce the time to lock your database. Providing a consistent set of CRF questions and responses will also lead to more compliant sites when it comes to entering data, and understanding what is expected of them when collecting their EDC study data.
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Setting Up and EDC Study Using CDISC Standards

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  • 24 Feb

When setting up an EDC study with CDISC standards, many questions typically arise. The five commonly asked questions below might look familiar:

  1. Why can’t the data simply be collected in SDTM format eliminating the need for CDASH?
  2. What are EDC study best practices when it comes creating a CDISC compliant CRF?
  3. What standard in CDISC has the ANSWERS to the QUESTIONS?
  4. How do I set up a custom CDASH CRF?
  5. What are vertical vs. horizontal datasets?
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5 Areas Where We Struggle with the Adoption of CDASH Standards

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  • 20 Dec
We perform case report form (CRF) designs for hundreds of studies each year and have seen many different CRF specifications. In the past year or two, we have had more customers want to standardize on CDASH standards. When educating our customers about CDASH, we have started to see several recommendations that have made a big impact on the study teams. Below are the top 5 changes that have made the biggest impact on the CDASH groups we have seen.
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6 Interesting Details Discussed at CDISC Interchange 2010

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  • 12 Nov
I’m back from the 2010 CDISC Interchange in Baltimore last week. The conference was once again very informative with discussion around some really intriguing topics. Below are the items I found most interesting at this year’s conference. FDA Presentation – Last year there was some uproar when Theresa Mullin, PhD, Director of Office of Planning and Informatics, Center for Drug Evaluation and Research (CDER) and the US Food and Drug Administration, announced that the FDA planned on standardizing on the HL7 data standard and not the CDISC standards. As Dr. Mullin started to speak this year, the audience was absolutely silent with anticipation. Dr. Mullin admitted there was some confusion after their presentation last year, and she made it clear that the FDA changed their tune and totally endorsed the use of CDISC standards. Whew!
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