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eSource Data in Clinical Investigations: FDA Clarifies Guidance on Regulatory Considerations Part 1

eSource Data in Clinical Investigations: FDA Clarifies Guidance on Regulatory Considerations Part 1

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  • 24 Jul

Despite the 8:00 AM session start time on Day 2 of the DIA Annual Conference in beautiful San Diego, California, study professionals packed the hall to hear FDA representatives speak on Electronic Source Data in Clinical Investigations: Regulatory Considerations.

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Bone Safety Studies for Diabetes Trials: A Q&A with Dr. Colin Miller

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  • 17 Jul

Later this month, Colin Miller, PhD, CSci will give a webinar focused on imaging endpoints for fracture risk assessment in clinical trials for diabetes drugs. As a preview to his webinar, I sat down with Colin to discuss the current regulatory landscape surrounding the safety of diabetes drugs and newer approaches that clinicians are using to monitor skeletal integrity.

1. What are some of the types of drugs that are available for treating diabetes?

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Data Management at Isis Pharmaceuticals

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  • 16 Jul

"Isis Pharmaceuticals has one of the most efficient data management departments for clinical trials I have ever seen." This is how Rich Murg, BioClinica Business Development Director, introduced the Isis Pharmaceuticals session led by Joan Baily during the recent BioClinica Global User Conference. That's saying a lot as Rich has met with many data management departments over the past eight years, assisting pharma companies and CROs with eClinical Solutions.

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How Endo Pharmaceuticals Achieved Rapid Study Start Up with a "Killer Collaborative UAT" for EDC

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  • 25 Jun

In my R&D role at Endo Pharmaceuticals, I have seen the lines between operations and clinical data functions becoming more and more blurred. Specialized technical skills are vitally important and they become ever more valuable when the people who possess them come together to work on solutions in a facilitated, collaborative environment.

The Challenge

We presented BioClinica with a challenge in October 2013:

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Extremely Large Databases (XLDB) Healthcare Workshop Applications in Medical Imaging

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  • 13 Jun

I was recently invited to attend the XLDB workshop at my alma mater Stony Brook University. The two day workshop brought together experts from industry and academia to explore the application of advanced large scale data analytics to the healthcare sector. Many of the presentations were focused on big data technologies and innovative solutions for leveraging extreme scale data sets to positively impact patient outcomes and efficiency in the healthcare system.

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Are You Monitoring Blood Pressure in a Clinical Trial?

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  • 19 May
I recently gave a webinar focused on the implementation and benefits of using remote cardiovascular monitoring (telemonitoring) for clinical trials. Remote monitoring provides a promising patient management approach that produces increased data reliability, availability and early trend analysis and patient compliance with trial protocols. As a companion to my webinar, here are three considerations for clinical trial sponsors when establishing an approach to identifying a blood pressure response (safety or efficacy endpoint) and selecting a blood pressure monitoring method for their study.
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Clinical Trial Metrics: Study Health Vital Signs

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  • 13 May

Is there a way to see at a glance how well my clinical study is doing?

Whether I'm talking to a study manager, data manager, supply chain manager, or executive, this is a question I hear again and again when discussing eClinical systems reporting.

The good news is, yes. There is a way to get a quick sense of the state of health your study is currently in. It is through the use of metrics. Leveraged properly, they can answer three of the most common questions concerning clinical trial health:

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Being Prepared: Alerts from Clinical Supply Pro, Buz Hillman

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  • 05 May

As clinical supply managers, we are not here for the times when things are going well. We are here because change happens and things go wrong that impact the supply chain.  We need to be able to see when change is coming and manage through that change.

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Dr. Colin Miller

Q&A with Dr. Colin Miller on Medical Imaging in Clinical Trials

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  • 28 Apr
Several of BioClinica's scientific and operational experts have made significant contributions to an important and comprehensive text titled Medical Imaging in Clinical Trials. I recently sat down with Dr. Colin Miller, Senior VP of Medical Affairs at BioClinica and co-editor of Medical Imaging in Clinical Trials to talk more about medical imaging in clinical trials. Here's what he had to say.
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Fun with the Kids at Bring Your Child to Work Day

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  • 25 Apr

On April 24th BioClinica ran "Bring Your Child to Work Day" programs in several of our offices, hosting the children of our employees for a full day of activities designed to be fun and educational.

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Applying Tumor Response Criteria for Skin Cancer Trials

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  • 18 Apr

Skin cancer is the most common cancer type, affecting more than 2 million people annually in the US alone. Given the rising incidence of skin cancer, mostly attributable to UV exposure, there are a large number of clinical trials in this area designed to test the efficacy of new drugs emerging from pharmaceutical pipelines.

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Advancing Remote Cardiovascular Safety in Clinical Trials

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  • 20 Mar

Advances in technology are facilitating the acquisition of comprehensive blood pressure (BP) datasets for clinical studies of cardiac safety and efficacy. Sponsors now have a continuum of choices for BP assessments including remote telemonitoring, which provides a promising patient management approach that produces increased data reliability and patient compliance with trial protocols.

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Clinical Trial Forecasting: Managing the Challenges and Avoiding the Fines

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  • 08 Aug

Last week, Jim Sacchetta, Manager, Technical Operations, Premier Research, and I hosted a webinar titled "Clinical Trial Forecasting: Managing the Challenges and Avoiding the Fines." During the webinar, we took an in-depth look at:

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Explosive Growth in Post-Approval Research Drives Increased Cost and Complexity

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  • 04 Aug

In the 1970s, post-approval studies were rarely performed. The 1980s saw a slight rise when the FDA began to require post-approval research as a condition for the approval of certain drugs. Fast forward to 2014, when a full 13.7% of total R&D costs was spent on conducting post-approval studies. What fueled this explosive growth in post-approval research in such a relatively short period of time? And – critically – what are the ramifications of that growth?

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Finding the Right End-to-End Safety Solution for Your Needs

Finding the Right End-to-End Safety Solution for Your Needs

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  • 25 Jul

Last week, I hosted a webinar titled, "Finding the Right End-to-End Safety Solution for Your Needs." During the webinar, we took an in-depth look at:

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The Art of the Rescue - Navigating Potential Pitfalls during Imaging Vendor Transition

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  • 21 Jul

Once considered a rarity within the medical imaging vendor space, the decision by sponsors to transition imaging core lab after startup has become increasingly more common. Due to the complexity of clinical trials, there may come a time where as a Sponsor you will need to transition vendors after study startup. Reasons for this change of service provider can typically involve challenges with the current provider's timelines, quality, resources, or expertise.

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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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