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Risk-Based Monitoring: Lessons Learned

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  • 01 Jun

RBM Insights Shared at the BioClinica Global User Conference

Part 1 of 2 It was both a great learning experience and fun to participate in another user conference, BioClinica's fifth and my third since joining the company in 2013. We spent quality time with both long-time collaborators and first-time partners.
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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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Remote Monitoring in RBM Q&A

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  • 12 May

Risk-based Management & Remote Monitoring: Visits, Data, Changing Roles

We promised to answer questions that came in following a recent BioClinica webinar. Here RBM expert, Trevor McCaw, addresses a two-part inquiry on remote monitoring.

Q: In risk-based monitoring, how are sponsors approaching remote monitoring visits? In remote review are monitors looking at every data point or is the remote visit guided more by the site risk assessment?

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Risk-Based Monitoring: RBM Expert Opinion

Risk-Based Monitoring: 5 Key Questions

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  • 28 Apr

The Facts on Risk, Plans, SDV vs. SDR, Roles, and Savings

RBM experts Courtney McBean and Mireille Zerola, a member of the TransCelerate RBM work stream, address five commonly asked questions (and clear up a few misconceptions) surrounding RBM and its underlying methodology.

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Data Champions in Risk-Based Monitoring

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  • 20 Apr

RBM-Enabling Technology Is Transforming Clinical Trials

Data Champions in Risk-Based Monitoring

The centuries-old saying, "knowledge is power" coined by Francis Bacon in 1597, is fitting in our risk-based monitoring (RBM) conversations today. In research − trial data is power. This is becoming even more apparent as our data is being used in new ways to inform monitoring and study management decisions to run better trials.

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New Approaches for Measuring Muscle Fatty Infiltration

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  • 17 Apr

BioClinica Collaborates with CDDA on Fatty Infiltration Tool (FIT)

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

Raising Clinical Trial Intelligence

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

Putting RBM methodologies into practice

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

The Making of an MVR with Microsoft Office Smarts and an Iron-Clad Audit Trail

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

Unified Microsoft Office-Smart CTMS, MVR

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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4 Considerations for Choosing Key Risk Indicators (KRIs)

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  • 14 Sep

As a project manager and subject matter expert for Bioclinica's Compass RBM software, I've seen more and more companies turning to intelligent monitoring tools to track site performance and put their risk-based monitoring strategy into practice. When setting up a tool such as Compass, it's essential to choose the most important aspects of your trial to track in order to monitor site performance and identify areas on which to focus the most attention.

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6 Advantages of an Agile Approach to Interactive Response Technology (IRT)

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  • 13 Sep

In clinical trials, randomization and trial supply management (RTSM) solutions help randomize the participant allocation and ensure the study design is balanced and trial supplies are available when and where they are needed. A key piece of those efforts is the use of interactive response technology (IRT) software.

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Post-Approval Research: Do You Have What It Takes?

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  • 08 Sep

Investments in post-approval research are rising steadily year on year. Chances are, post-approval research represents a substantial part of your annual budget. But how much of that money is being wasted by conducting post-approval studies in an inappropriate and inefficient manner?

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For EDCs, Flexibility is Key

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  • 06 Sep

Given the number of data sources that have to be integrated with your electronic data capture system (EDC), it's important to take flexibility into consideration when choosing an EDC. However, some EDCs make integrating with other systems easier than others. Bioclinica's Express EDC was built by data managers for data managers, so we understand how important ease of integration is in an EDC, and we built it with that flexibility in mind.

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