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New Approaches for Measuring Muscle Fatty Infiltration

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  • 17 Apr

Clinical Trial FIT-ness: New Approaches for Measuring Fat

The presence of fatty infiltration in muscles of the lower extremities (thigh and calf) serves as a proxy for impaired muscle function and metabolic status, often seen with musculoskeletal diseases like osteoarthritis (OA), Sarcopenia, Duchenne Muscular Dystrophy, Pompe disease and Polymyositis/Dermatomyositis. Most clinical research for musculoskeletal diseases relies on non-invasive imaging methodologies for assessing changes in inter-muscular adipose tissue (inter-MAT), intra-muscular adipose tissue (intra-MAT) and muscle in the lower extremities.

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The Four Pillars of Intelligent Monitoring

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  • 24 Mar

Risk-Based Monitoring (RBM) Evidence Mounting In the recent paper from industry consortium TransCelerate BioPharma, Inc., Evaluating Source Data Verification as a Quality Control Measure in Clinical Trials (available here) issued in November 2014, RBM gains further support as evidence from actual clinical trials is presented corroborating earlier findings cited by the US FDA and EMA.

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Practical Risk Based Monitoring Methodologies

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  • 17 Mar

eClinical Greetings from Barcelona!
Jonathan Andrus
After a few crimps in the travel plans thanks to another winter storm hitting the US, everyone arrived safe and sound in sunny Barcelona for our second Annual European User Conference. It was two days of quality time with our customers and partners (recapped here in a news release).

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CTMS Microsoft SharePoint Integration Key to CROs

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  • 12 Mar

CTMS: Microsoft SharePoint Integration
When surrounded by such beauty and energy in Barcelona, who wants to sleep? Having just returned from BioClinica's European User Conference there last week, I admit I'm still reacclimatizing to the UK as I write this.

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Site Monitoring Reinvented Part 2

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  • 02 Mar

Regulatory authorities require clinical trial progress to be monitored. The site visit report, known as the Monitor Visit Report (MVR), is where sponsors provide evidence that all regulated activities have been completed along with documentation of the outcome. These reports are open to regulatory inspection at any time during a study, as well as after, and even post product approval.

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Site Monitoring Reinvented Part 1

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  • 02 Mar

CTMS and MVR, Across the Great Divide
As anyone in pharma knows, our industry is undergoing major change; clinical trials are rapidly evolving and eClinical technologies are becoming more sophisticated by the day. Meanwhile site monitoring continues to be one of the most critical, costly, and labor-intensive activities in a clinical trial. Looking for a better way to address this, many organizations have made the switch from conventional CTMS to the "Microsoft Office-Smart" model.

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Evaluating Cardiotoxicity: The Importance of Strain Imaging

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  • 27 Feb

Cardiotoxicity stemming from oncology drugs is a common problem facing drug sponsors, clinicians and cancer patients. Drug-induced cardiotoxic effects can be classified based on the mechanism of toxicity into three broad categories: myocardial damage and Left Ventricular (LV) dysfunction, vascular abnormalities and hypertension, and QT prolongation and arrhythmias.

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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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Escalating Role of Medical Imaging in AD Clinical Trials

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  • 30 Jan

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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Meet the Bioclinica eClinical Team: Amanda Nite, Senior Director of RTSM

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  • 17 Jan

Our flexible and innovative suite of eClinical solutions is supported by a team of people who have experience in all facets of clinical trials, which has been invaluable to our success. Therefore, we wanted to highlight a few valued contributors in this “Meet the Team” blog series.

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ROI Initiative: A Technology Solution for Investigator Payments

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  • 12 Jan

Managing investigator payments faces specific, well-known challenges. Current systems are fragmented and manual, and in most cases are not transactional or financial-based.

The result of continuing with current processes is the inability to manage the complexity of the contract and budget terms that are negotiated and paid throughout the course of a clinical trial. Current document management systems (e.g., CTMS and other homegrown systems) are based on non-financial system information that doesn’t manage or account for the accuracy of payments made.

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Is It Time to Embed Supply Chain Forecasting in Interactive Response Technology?

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  • 04 Jan

Some of my Bioclinica colleagues and I recently attended CBI's IRT 2016 conference in Philadelphia. While there were plenty of interesting topics discussed at the conference, one presentation particularly stuck out to me: the benefits of connecting supply chain forecasting for clinical trials more closely with interactive response technology (IRT) software. The reliance of effective clinical trial forecasting on IRT data is well understood within the clinical trial world, and was a big talking point at the conference.

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Meet the Bioclinica eClinical Team: Kristin Mauri, Global Head of Risk-Based Monitoring

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  • 18 Nov

Bioclinica's suite of eClinical solutions is designed to make your next clinical trial easier for you, your investigators and even your subjects. Our flexible and innovative eClinical solutions are supported by a team of people who have experience in all facets of clinical trials and help our clients seamlessly adopt new technologies and processes to improve their trials. Our team members are invaluable to our success, so we wanted to highlight a few of them in a "Meet the Team" blog series.

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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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"Medical record mud run" 1 obstacle in vaccine trials w elderly. Here R 5 more & how to conquer by Dr. Craig Curti… https://t.co/5rO4jURlVF
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