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IRT Sourcing Models, Breaking with Convention (Part 2)

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  • 18 Feb

What Makes an IRT Great for Technology Transfer?

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

Technology Transfer Gaining on Saas

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

Break-out Group Dissects the Development of a Risk-Based Approach To Clinical Trial Management

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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Escalating Role of Medical Imaging in AD Clinical Trials

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  • 30 Jan

Studies Reveal Impact of Implementing, Standardizing, and Developing Neuroimaging Endpoints in Alzheimer's Disease Trials

Alzheimer's disease is one of the most important health challenges facing aging populations worldwide. Disease modifying therapies are desperately needed and many potential treatments are currently being tested in clinical trials. The role and impact of medical imaging in AD trials continues to grow, especially as clinicians and scientists seek to define and treat AD at the earliest stages of disease.

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Risk-Based Monitoring Technology: 5 Essential Capabilities

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  • 27 Jan

If you've spent time researching risk-based monitoring (RBM) over the past year, you know dozens of academics, CROs, clinical trial practitioners, and statisticians have proposed varied approaches based on sponsor needs and trial designs. Unfortunately, despite an abundance of theoretical perspectives on RBM, clinical trial teams soon discover a significant gap still exists between perspectives and actual tools to enable real-world RBM implementation.

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Time to Take Action and Make Risk-Based Monitoring a Reality

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  • 19 Jan

Intense interest surrounding RBM shows alignment of all the right elements — technology, regulatory bodies and the industry itself – to make risk-based monitoring a reality. If implemented with the right components, this approach could result in the most efficient trial management possible.

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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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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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3 Reasons to Share Data from Unsuccessful Clinical Trials

3 Reasons to Share Data from Unsuccessful Clinical Trials

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  • 25 Nov

A recent proposal by the U.S. Department of Health and Human Services (HHS) could expand the amount of clinical trial data that drug companies must share with the public. Under the proposal, clinical trial sponsors would be required to report findings for drugs and devices that fail to reach approval.
 

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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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Risk-Based Monitoring Versus Intelligent Monitoring

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  • 31 Oct

Why Intelligent Monitoring is Even Smarter

When I speak on the topic of risk-based monitoring (RBM) at industry events, someone invariably comes up afterward to say how nice it is we finally stopped talking about risk-based monitoring!

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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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Is Your Clinical Trial Payments System Scalable?

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  • 25 Aug

At Bioclinica, we often talk with CROs who have outgrown their site payment systems. Whether they're using spreadsheets or a manual, homegrown system, as the number of trials they're conducting increases, CROs often find that their current systems can't keep up.

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Elizabeth Thiele

Patient Recruitment and Retention for Healthier Studies

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  • 18 Aug

Finding patients to participate in clinical trials and keeping them engaged for the duration are two of the greatest challenges in the clinical development process. Yet, as our President and CEO John Hubbard sees it, "Every major challenge is also an opportunity to improve the clinical development process." To overcome such hurdles, we as an industry must become more efficient in conducting clinical trials while simultaneously keeping a keen focus on the patient.

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Questions to Help You Automate the Financial Lifecycle of Your Global Clinical Trials

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  • 18 Aug

During my years in the healthcare industry working closely with CROs and sponsors, I've seen many organizations realize the benefits of switching from manual payment processes like Excel spreadsheets, which are time- and resource-intensive as well as error-prone, to automated payment solutions.

I continue to receive questions regarding our software and automating the financial lifecycle of global clinical trials. I'd like to address some key questions in this blog post so that everyone can benefit from the feedback.

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Risk-Based Monitoring Cost Savings: The Icing on the Cake Not the Cake Itself

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  • 16 Aug

Reducing monitoring costs continues to be the primary driver to adopting risk-based monitoring (RBM). But should that be the leading metric?

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