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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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Pathway to Quality Cardiovascular Imaging Trials

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  • 13 Mar

Cardiovascular diseases are the leading cause of death in the world and as such, the cause, prevention and treatment of all cardiovascular disease remains a very active field in the research community. Cardiovascular Imaging is a primary therapeutic service area for Bioclinica, offering comprehensive centralized medical imaging services and support for the majority of all cardiovascular imaging (CVI) modalities leveraged to provide critical endpoint assessments in clinical research.

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Does Your RBM System Support the Recently Revised Guidelines to Have a QMS in Place?

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  • 03 Mar

The latest International Council for Harmonisation (ICH) Good Clinical Practice (GCP) E6 addendum includes recommendations for ensuring quality management in clinical trials at the forefront. In particular, the new section 5.0 outlines recommendations for quality management, stating that "sponsors should focus on trial activities essential to ensuring human subject protection and the reliability of trial results" within the seven areas that are described below.

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7 Advantages of a Site Network vs. Individual Sites for Clinical Trials

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  • 24 Feb

How many investigative sites will you need for your next clinical trial? Will you choose independently-operated sites or a network of sites? Do you know their differences and advantages? We polled our Research Network customers and staff, and share what they said in this blog.

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Reflections on My Experience at the 2017 DIA Pharmacovigilance and Risk Management Strategies Conference

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  • 22 Feb

Compared with the 2016 Drug Industry Association (DIA) Pharmacovigilance and Risk Management Strategies Conference, the 2017 conference in Washington, D.C. had a much better start. Although I was not at last year's conference, I read the epic testimonials of snowstorms, canceled flights, lockdowns and other interesting events, which were all very entertaining.

This year's DIA Pharmacovigilance and Risk Management Strategies Conference, which I attended, was less eventful, and yet, still full of encounters, lively discussions and as always, laughter.

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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.

RT @eClinical_Jen: FREE on-demand webinars from @bioclinica on EDC, Imaging, RBM, and Clinical Trial Management. Tell them I sent you! http…
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Cardiovascular imaging use is growing in non-cardiovascular areas #ClinicalTrials. See where in Tim Crowe's blog… https://t.co/dYjPBC0Wtn
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RT @Xtalks: Cardiovascular Safety in #Biopharmaceutical Product Development - From QT Prolongation and Beyond @bioclinica https://t.co/mCk1…
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