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Classic Blog

Lilly's Amyvid Gets FDA Advisory Panel Approval for Alzheimer's

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  • 21 Jan
Following my recent blog post on PET imaging and Alzheimer’s disease, the FDA Advisory Panel recommended the approval of the Lilly compound “Amyvid”. Lilly bought AVID Radiopharmaceuticals last year. This is the first compound of its kind to be given this level of approval...
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MRI in Rheumatoid Arthritis Clinical Trials

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  • 13 Jan

At BioClinica we are fortunate to have a medical affairs group staffed with a medically and scientifically qualified team whose role is to help sponsors with imaging protocol design and how to use emerging technologies to our advantage. Harris Ahmad, M.D.

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Sarcopenia and Aging: ASBMR Annual Meeting Hot Topic

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  • 10 Jan
Late last year I attended the annual meeting of the American Society of Bone & Mineral Research (ASBMR) in Toronto. One of the hot topics was sarcopenia, a term which describes the process associated with muscle loss, something that occurs as we get older. The term is derived from greek roots, sarx (flesh) and penia (loss). A lot of research has taken place in osteoporosis and its prevention but sarcopenia has considerable clinical significance. Age-related reduction in muscle mass, function and strength leads to the reduced ability to undertake the physical activities of daily living together with an increased risk of fall and related injury. Loss of muscle mass is therefore associated with risk of fracture.
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5 Areas Where We Struggle with the Adoption of CDASH Standards

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  • 20 Dec
We perform case report form (CRF) designs for hundreds of studies each year and have seen many different CRF specifications. In the past year or two, we have had more customers want to standardize on CDASH standards. When educating our customers about CDASH, we have started to see several recommendations that have made a big impact on the study teams. Below are the top 5 changes that have made the biggest impact on the CDASH groups we have seen.
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NFL football concussion research and the use of fMRI

The Use of fMRI Imaging in Football Concussion Research

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  • 02 Dec
Many of you know that I am a Philadelphia Eagles fan, so I was interested to read about the use of functional magnetic resonance imaging (fMRI) to do neurological clinical trial research on concussions in football players. Sports Illustrated raised the awareness of the impact of concussions in a series of articles in their November 1st issue, including the iconic cover of the magazine.
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How Time, Quality & Cost Metrics Affect Clinical Trials and Programs

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  • 22 Nov
There are principally three characteristics, or metrics, we can use to measure any major process: TIME. QUALITY. COST. The challenge is that these three are in competition. Nowhere is this more apparent than in the design and implementation of clinical trials and clinical programs. There are three characteristics but you can only emphasize 2! In the current environment we have seen COST become the main driver throughout the pharmaceutical and biotech industry. However, this usually works at the long-term penalty of quality and or time. A recent case in point was a small company that asked us to handle the imaging portion of the clinical trial. Everything was pared down to yield the most apparent “cost effective solution” at the outset. We are now half way through the trial and key imaging end points need to be delivered and safety evaluations are being considered. Suddenly the need for quality has come to the forefront, particularly as the data will be going to a regulatory agency. However, this shift has caused increases in scope of work that may be exceed the original budget and possibly be higher than necessary due to the amount of rework, which would have been negated if the need for quality had been more carefully considered at the start. Furthermore, time is of the essence, but due to prior decisions it has to take second place behind the quality issues.
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6 Interesting Details Discussed at CDISC Interchange 2010

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  • 12 Nov
I’m back from the 2010 CDISC Interchange in Baltimore last week. The conference was once again very informative with discussion around some really intriguing topics. Below are the items I found most interesting at this year’s conference. FDA Presentation – Last year there was some uproar when Theresa Mullin, PhD, Director of Office of Planning and Informatics, Center for Drug Evaluation and Research (CDER) and the US Food and Drug Administration, announced that the FDA planned on standardizing on the HL7 data standard and not the CDISC standards. As Dr. Mullin started to speak this year, the audience was absolutely silent with anticipation. Dr. Mullin admitted there was some confusion after their presentation last year, and she made it clear that the FDA changed their tune and totally endorsed the use of CDISC standards. Whew!
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MelaFind: assisting physicians in early melanoma detection

Melanoma Imaging Device for Early Detection & Diagnosis

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  • 26 Oct
One of my roles at BioClinica is to keep my finger on the pulse of innovative new medical imaging devices in development and to think how these could be applied to future clinical trials. An imaging device that recently caught my attention is MelaFind® from Mela Sciences (formerly Electrical-Optical Sciences). It is a hand-held multispectral digital imaging device that can be used to identify skin lesions that should be biopsied for melanoma. Not much scientific information on this melanoma imaging device is provided on the website, but the device seems to be using an Optical Coherence Tomography (OCT) type of system. I previously wrote about OCT in an early blog post that can be found here.
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The Role of Imaging Endpoints in Biosimilar Comparability

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  • 22 Oct
A biosimilar is a copy of a biologic drug, i.e. one made from living cells such as monoclonal antibodies or recombinant proteins. The term “follow-on biologics” or “biogenerics” is also used to describe the products that companies want to launch after the patent expiration of an established biologic product on the market. Typically for a generic drug approval it is sufficient to show that a chemical compound is therapeutically equivalent to the marketed version. This is relatively straightforward since chemical analysis can show the same active ingredients and a bioequivalence study can show comparable pharmacokinetics. Formal trials on clinical safety and efficacy are not required.
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Clinical Supply Simulation & Optimization: ClinPage.com Article

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  • 18 Oct
Following on several speaking engagements this year, I was recently interviewed by Mark Uehling of ClinPage to discuss some current developments in the field of clinical supply simulation and optimization. Because of Mark’s propensity to research and present (sometimes dry) information in unique and interesting ways, interviews with ClinPage are always fun - and this one was no exception! We covered topics ranging from the adoption of simulation tools in large pharmaceuticals (hint: > 50%) to the wide variety of benefits that companies realize from simulation beyond just dollar savings on clinical supply.
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Clinical Data Managers: Should You Be a Tattletale with Your Metrics?

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  • 15 Oct

As a clinical data manager, do you want your study team to know that you review fewer pages than all the other clinical data managers?  As a clinical manager, would you like to easily see which sites are entering data within 48 hours of the patient visit, and which sites are waiting a week or two?

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Are Placebo-Controlled Trials in Osteoporosis Ethical?

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  • 13 Oct
The New England Journal of Medicine has entered the debate around whether it is ethical to have placebo-controlled trials in osteoporosis. For those of us involved in clinical research in osteoporosis, this is a fascinating debate and reflects the challenge between the regulatory requirements and current ethical understanding, which are always intertwined. Placebo in this arena always consists of Vitamin D and Calcium supplementation, which have some bone sparing effects. However, there is a good range of therapies on the market with proven efficacy.
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RBM is Advancing: 3 Keys in Planning

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  • 09 Mar

While Miami warmth and sunshine in February was undoubtedly a main draw for some SCOPE Summit attendees, for the risk-based monitoring set it was something more. It was about the opportunity for our diverse group of stakeholders to come together and give feedback in an area increasingly growing in importance - quality and risk management.

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Governance and Collaboration: CTMS Checklist

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  • 02 Mar

A recent market research report forecasts that the eClinical solutions market will be worth 5.98 billion (USD) by 2020. With sponsors and CROs adopting new eClinical software, or replacing legacy systems, such as clinical trial management systems (CTMS), vendors are emerging with new software to stake a claim in this growing market.

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The Scoop from SCOPE Summit 2016

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  • 25 Feb

SCOPE Summit 2016 was a busy and exciting event for the Bioclinica team! In addition to the great discussions at the Bioclinica booth, Ron Burns, VP, Product Management, Bioclinica eHealth Solutions, held a session entitled, "Integrating Mobile Application Generated Patient Data into Your Risk-Based Monitoring Strategy." This session included Bioclinica eHealth App xChange Partner, AiCure.

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Get a First-Hand Glimpse into the Power of Mobile Application Generated Patient Data at SCOPE Summit 2016

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  • 18 Feb

The rapid growth of technology is revolutionizing the way clinical trials are conducted. Increasing adoption of smartphone use -- forecasted to reach over 6 billion by 2021 – combined with the growing biosensors market opens up new possibilities for a variety of healthcare-related uses. Innovative patient-centered mobile applications and biosensors now connect patients with physicians and other healthcare providers.

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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.

Handy guide for the pharmacovigilance folks! https://t.co/tOyQWkiNhW
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#ClinicalResearch sites, REJOICE @bioclinica SMART Submit 4 cloud rsch image mgmt /subm is here! @OutsourcPharmahttp://ow.ly/odCh30grhnY
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What's next from Bioclinica? Hear if first during #PCTrials Europe next week in Amsterdam! https://t.co/ICngaxA9mg https://t.co/SXxPj3NpD2
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Join Bioclinica's Justin Hunt on Nov. 28 in a live webinar! Find out how to overcome common hurdles in CTMS impleme… https://t.co/wHfWHtI7sj
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Another CRO seeing big gains in the sites payments process! Access the Case Study here https://t.co/jsCxhmKcLo https://t.co/LpIKEtBKtE
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Great advice from our Dir. Cardiovascular Imaging on quality imaging acquisitions & assessments in clin trials. https://t.co/OVH7pZ3SL0
bioclinica (4 days ago)

Latest Blogs:

Removing Risk from Clinical Trial Management System (CTMS) Implementations
Collaboration Between Clinical Operations and the Logistics and Supply Chain Teams is Key to Trial Success
The Value of Protocol Review
CTMS and RBM: Hot Topics at OCT Nordics in Copenhagen
Congressman Meehan and Bioclinica CEO John Hubbard at recent visit to Bioclinica's Audubon offices