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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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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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Powerful Post-Approval Operational Strategies for the 21st Century

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  • 03 Nov
Post-approval research studies are vastly different from pre-market studies designed for the registration of a new drug or device. In the white paper "One Size Doesn’t Fit All": Applying an Innovative Mindset to Post-Approval Research, I outline these differences and illustrate why companies ought to leverage strategies, processes, standard operating procedures (SOPs), and technologies that are specifically designed for and more relevant to post-approval research.
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3 Considerations When Implementing Risk-Based Monitoring Software

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  • 02 Nov

With regulatory agencies placing greater emphasis on risk-based monitoring (RBM) in clinical trials, the use of tools for RBM has become more and more crucial to success within the industry. If you're considering adopting an intelligent monitoring solution or if you're in the early stages of implementing such a tool, it's important to set yourself up for success early on by keeping a few things in mind. In my experience working with customers to implement Compass, I've learned a few key criteria that companies should consider to ensure RBM success.

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Trends in Asia Drug Development Market

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  • 01 Nov

Innovation and Harmonization on the Rise

As R&D costs continue to hit new heights and domestic participation in clinical trials wane, more and more biopharmaceutical companies are seeking ways to mitigate costs and access new patient populations. Over the past decade, these driving market forces have contributed to a sharp rise in R&D activities, pharmaceutical market size, and the number of clinical trials conducted in Asia.

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What Effect Does ICH E6 R2 Have on Risk-Based Monitoring and Overall Quality Risk Management?

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  • 17 Oct

Last week I hosted a webinar called "What Effect Does ICH E6 R2 Have on Risk-Based Monitoring and Overall Quality Risk Management?" The webinar focused on the recent revision to the ICH Guideline for Good Clinical Practice (E6 R2), which primarily addresses quality management with a focus on risk identification, evaluation, control, review and reporting. During the session, I discussed:

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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 @DrugInfoAssn: What has been the biggest takeway for your organization so far? Tweet @ us using #DIA2017
bioclinica (Yesterday)
"Q" on #RBM & Total Quality Mgmt? @Kristin_Mauri has "A" @DrugInfoAssn #DIA2017 https://t.co/MqCxkmAfa0
bioclinica (Yesterday)
Kristen Mauri shows the @DIA audience the value of risk based monitoring https://t.co/ssJCfc9gQ5
bioclinica (Yesterday)
Innovation Theater Kristin Mauri of @bioclinica presenting on RBM & TQM @DrugInfoAssn #DIA2017 https://t.co/zsGroQcpiU
bioclinica (Yesterday)
Innovation Theater @DrugInfoAssn #DIA2017 Kicking off at 1. Perspectives on risk-based monitoring and TQM. https://t.co/mH6Npg0kD4
bioclinica (Yesterday)
RT @Xtalks: How Improving Site Payments Can Make You the Sponsor/CRO of Choice Tune in for this live webinar with @bioclinica https://t.co/…
bioclinica (Yesterday)

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