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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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2016 CDISC International Interchange: Standards, Metadata and the FDA

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  • 13 Oct

The last week of September, I had the opportunity to be a chair on the EHR/MDR session at the 2016 CDISC International Interchange in Maryland. I always enjoy being involved with the CDISC Interchange; it is inspiring to see all the people who are passionate about submitting quality standardized data to the FDA to make better lives for us all.

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Biomarkers for Alzheimer's Disease – Where are we now and Where are we going?

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  • 04 Oct

Last July, the Alzheimer's disease community gathered in Toronto for the Alzheimer's Association International Conference (AAIC) to share the latest advances in AD research and clinical trials.

Dementia is a global health issue as it affects over 45 million people worldwide and is recognized as a public health priority by the World Health Organization (WHO). Alzheimer's disease (AD) is a fatal degenerative brain disease and is the most common cause of dementia, accounting for an estimated 60 to 80% of cases1.

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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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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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Stronger Through Collaboration: A new wave of eHealth Solutions

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  • 15 Aug

Learning about new technologies and thinking strategically about their application in life sciences to ultimately benefit patients is what motivates me. This makes my role at Bioclinica a perfect fit as I get to partner with developers of innovative patient-centered applications from around the world for our eHealth App xChange.

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Streamline the Financial Management of Your Trials With the ClinPay and ClinPlan Integration

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  • 22 Jun

Although our financial lifecycle solutions are powerful on their own, they provide even greater benefits when used together. This is especially true of ClinPay and ClinPlan; the recent integration of these two products streamlines the financial lifecycle of clinical trials from end to end.

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The Increasing Role of Technology in Supporting ICH E6 R2

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  • 16 Jun

As you may already be aware, a key recommendation in the latest revision to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH E6 R2), finalized in November 2016, is the use of a quality-based approach inclusive of risk-based monitoring (RBM). It also recommends centralized monitoring processes. These should complement and potentially allow you to reduce the extent and frequency of on-site monitoring, freeing up valuable resources and providing the opportunity to:

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Recruiting Senior Citizens for Vaccine Trials Requires Circle of Trust

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  • 15 Jun

Senior citizens tend to have less-than-optimal vaccination rates – even for proven vaccines that bring significant health benefits. Unsurprisingly, then, they are hesitant to engage in vaccine-related clinical trials to test new medications. The way to remove this hesitancy is to engage senior citizens by building a circle of trust: a circle that has as its center the education of both the site staff and potential patients.

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Upcoming Webinar: How Improving Site Payments Can Make You the Sponsor/CRO of Choice

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  • 13 Jun

Join us for our upcoming webinar on June 27th where Lorie McClain, the VP of Product Management and Product Development and Technology at Bioclinica, Inc., and other Bioclinica clinical payments experts will present and discuss case studies illustrating how trial sponsors and CROs are becoming partners of choice at high-performing sites.

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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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