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Bioclinica Demonstrates EHR to CDASH (E2C) Standard

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  • 06 Jan

Ever since the US FDA introduced Meaningful Use requirements calling for medical practices to begin using EHR systems, the race was on to find a way to pull the data from EHR systems into the EDC systems electronically.  Many options have been tried − most focused on accessing the data from the EHR in the native HL7 format.  While this solution works, it's not easy to do. One of the stumbling blocks is the inability of site personnel to access this type of data from their EHR.

Eager to find a solution, our Express EDC team rolled up its sleeves to work on the CDISC initiative.

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2015 Asia Events

Expanding Opportunities for Drug Development in Asia

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  • 06 Oct

Over the last decade, R&D activities, pharmaceutical market size, and the number of clinical trials in Asia has grown tremendously.  As a result, Asian biopharmaceutical companies are developing more products for commercialization in the global market, and International drug development service companies have moved many R&D functions and commercial operations to the APAC region.

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CSF biomarkers & Alzheimer's Disease

CSF Biomarkers and the advancement of Alzheimer's Disease Trials

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  • 03 Aug

The Importance of Early Diagnosis for AD Last month, scientists, clinicians, drug sponsors, and regulators gathered in our nation's capital at the annual Alzheimer's Association International Conference (AAIC) to share recent advances in AD research and clinical drug development.

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How RBM Technology Strengthens Sponsor-Site Ties

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  • 10 Jun

Why does it seem like problems surface at clinical research sites right about when the study team is either busy preparing for a monitoring visit or immediately following one?

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Imaging biomarkers, molecular imaging in oncology clinical trials

Leveraging Imaging Biomarkers to Improve Drug Development

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  • 02 Jun

Clinicians need ways to better predict patient responses

The estimated cost for developing a drug is approaching upwards of $5 Billion dollars with a process spanning well over a decade. Coupled with high failure rates in late phase clinical trials and increased complexities in acquiring and analyzing clinical trial data, traditional approaches based on the premise of "one size fits all" are becoming less cost effective and suboptimal.

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eClinical Lessons Learned

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  • 01 Jun

Part 2 of 2

In my last blog, I shared risk-based monitoring (RBM) lessons learned and RBM insights from the  BioClinica 5th Annual BioClinica Global User Conference held in May in Orlando, Florida.  Here is a recap of other eClinical sessions I had the pleasure of attending.

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Risk-Based Monitoring: Lessons Learned

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  • 01 Jun

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

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.

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Risk-Based Monitoring: RBM Expert Opinion

Risk-Based Monitoring: 5 Key Questions

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  • 28 Apr

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

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

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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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 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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RT @MySCRS: 96.7% of patients want to know results of #ClinicalTrials yet only 9% are able to find them after study ends. https://t.co/SxtG…
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