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Clinical Trial Standards

IRT Sourcing Models, Breaking with Convention (Part 2)

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  • 18 Feb

In the last blog we talked about how technology transfer is gaining ground on the conventional Software as a Service (SaaS) IRT sourcing model. In this blog post, I will explain the advantages of the technology and design behind Trident that make it particularly well-suited for IRT technology transfer. So let's dive right in.

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IRT Sourcing Models, Breaking with Convention (Part 1)

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  • 18 Feb

When it comes to Interactive Response Technology (IRT) – systems used to perform subject randomization, drug dispensing and study drug resupply – Software as a Service (SaaS) continues to be the conventional delivery model including here at BioClinica.

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Key Insights from SCDM Euro Leadership Forum

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  • 06 Feb

As SCDM's 2014 Chair I had the honor of presenting the keynote at the EU Leadership Forum held in The Netherlands, December 2014. Celebrating the organization's 20th Anniversary and all that's been accomplished, we took a light-hearted look at the Evolution of the Clinical Data Management Role.

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Evolution of the Clinical Data Management Role, 1994-2014

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  • 09 Dec

20-Year Retrospective

The role of the Clinical Data Manager (CDM) has changed immensely since 1994, both in terms of role and function. Let's take a fun retrospective look at the great strides made in our field over these last 20 years, and more importantly, where the CDM role is headed. Let's begin with 1994, in honor of the Society of Clinical Data Management (SCDM), which commemorated its 20th Anniversary in 2014.

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eSource Data in Clinical Investigations: FDA Clarifies Guidance on Regulatory Considerations Part 2

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  • 01 Aug

As promised in my last blog, here is the re-cap about Electronic Source Data in Clinical Investigations: Regulatory Considerations, a session presented by the FDA during the DIA annual conference.

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eSource Data in Clinical Investigations: FDA Clarifies Guidance on Regulatory Considerations Part 1

eSource Data in Clinical Investigations: FDA Clarifies Guidance on Regulatory Considerations Part 1

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  • 24 Jul

Despite the 8:00 AM session start time on Day 2 of the DIA Annual Conference in beautiful San Diego, California, study professionals packed the hall to hear FDA representatives speak on Electronic Source Data in Clinical Investigations: Regulatory Considerations.

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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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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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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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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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FDA biosimilar guidance for clinical trials

FDA Biosimilar Guidance Expected to Lead to More Clinical Trials

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  • 23 May
Earlier this year, the U.S. Food and Drug Administration (FDA) issued guidance on the development of biosimilars, defined as a — "Biological product that is highly similar to an already approved biological product, notwithstanding minor differences in clinically inactive components, and for which there are no clinically meaningful differences between the biosimilar and the approved product in terms of the safety, purity and potency." Biologics include vaccines, blood and blood products, gene therapies and proteins. These are typically large molecules, as compared to small molecule pharmaceutical drugs. Examples of top selling biologics in the United States include Aranesp, Procrit and Epogen for anemia, Lucentis for macular degeneration, Herceptin, Rituxan and Avastin for cancer & Remicade, Humira and Enbrel for rheumatoid arthritis.
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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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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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