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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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Meet the Bioclinica Safety and Regulatory Team: Sukrit Singh, Engagement Manager

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  • 07 Nov

Bioclinica's Safety and Regulatory Solutions division provides optimal drug safety, regulatory affairs and clinical services to CROs and sponsors. Our services are supported by our knowledgeable team members, who have experience in a wide variety of roles within the safety and regulatory sphere of clinical trials.

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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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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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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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Why Your RBM System Should be SMART, Not Pretty

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  • 09 Feb

There is long-standing recognition that Risk-Based Monitoring (RBM) is essential to ensuring the safety of your patients and the success of your clinical trial. Data quality and patient safety are also at the core of quality by design (QbD) initiatives, which focus on identifying key risks to subject safety, data quality and GCP/regulatory compliance, setting the foundation for RBM implementation.

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How Optimizing Your Supply Chain Management Can Reduce Trial Cost, Effort and Risk

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  • 07 Feb
Today's Supply Chain
We can all recognize that there is a need to better manage the increasingly uncertain and complex drug supply chain, which is affected by the inclusion of more patients, at more sites and in more countries; country-specific regulations and approvals for temperature-controlled drugs, packaging, labeling and logistics; and more intricate protocols.
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When Designing Clinical Trial Software, Put Your Users First

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  • 20 Jan

What's the best way to design software that your customers will actually enjoy using?

Ask your users.

It sounds obvious enough, but you would be surprised by how infrequently this perspective is taken into consideration when designing clinical trial software.

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Bioclinica is divided into three business segments so that we can provide expert service and multifaceted technologies. Our Medical Imaging and Biomarkers segment includes an Imaging Core Lab, a Cardiovascular Safety division, and a Biomarker Laboratory. Our eHealth segment comprises an eClinical Solutions Division along with Safety and Regulatory 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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