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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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The Four Pillars of Intelligent Monitoring

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  • 24 Mar

Risk-Based Monitoring (RBM) Evidence Mounting In the recent paper from industry consortium TransCelerate BioPharma, Inc., Evaluating Source Data Verification as a Quality Control Measure in Clinical Trials (available here) issued in November 2014, RBM gains further support as evidence from actual clinical trials is presented corroborating earlier findings cited by the US FDA and EMA.

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Practical Risk Based Monitoring Methodologies

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  • 17 Mar

eClinical Greetings from Barcelona!
Jonathan Andrus
After a few crimps in the travel plans thanks to another winter storm hitting the US, everyone arrived safe and sound in sunny Barcelona for our second Annual European User Conference. It was two days of quality time with our customers and partners (recapped here in a news release).

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CTMS Microsoft SharePoint Integration Key to CROs

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  • 12 Mar

CTMS: Microsoft SharePoint Integration
When surrounded by such beauty and energy in Barcelona, who wants to sleep? Having just returned from BioClinica's European User Conference there last week, I admit I'm still reacclimatizing to the UK as I write this.

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Site Monitoring Reinvented Part 2

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  • 02 Mar

Regulatory authorities require clinical trial progress to be monitored. The site visit report, known as the Monitor Visit Report (MVR), is where sponsors provide evidence that all regulated activities have been completed along with documentation of the outcome. These reports are open to regulatory inspection at any time during a study, as well as after, and even post product approval.

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ROI Initiative: A Technology Solution for Investigator Payments

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  • 12 Jan

Managing investigator payments faces specific, well-known challenges. Current systems are fragmented and manual, and in most cases are not transactional or financial-based.

The result of continuing with current processes is the inability to manage the complexity of the contract and budget terms that are negotiated and paid throughout the course of a clinical trial. Current document management systems (e.g., CTMS and other homegrown systems) are based on non-financial system information that doesn’t manage or account for the accuracy of payments made.

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Is It Time to Embed Supply Chain Forecasting in Interactive Response Technology?

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  • 04 Jan

Some of my Bioclinica colleagues and I recently attended CBI's IRT 2016 conference in Philadelphia. While there were plenty of interesting topics discussed at the conference, one presentation particularly stuck out to me: the benefits of connecting supply chain forecasting for clinical trials more closely with interactive response technology (IRT) software. The reliance of effective clinical trial forecasting on IRT data is well understood within the clinical trial world, and was a big talking point at the conference.

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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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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.

RT @DrugInfoAssn: What has been the biggest takeway for your organization so far? Tweet @ us using #DIA2017
bioclinica (Yesterday)
"Q" on #RBM & Total Quality Mgmt? @Kristin_Mauri has "A" @DrugInfoAssn #DIA2017 https://t.co/MqCxkmAfa0
bioclinica (Yesterday)
Kristen Mauri shows the @DIA audience the value of risk based monitoring https://t.co/ssJCfc9gQ5
bioclinica (Yesterday)
Innovation Theater Kristin Mauri of @bioclinica presenting on RBM & TQM @DrugInfoAssn #DIA2017 https://t.co/zsGroQcpiU
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Innovation Theater @DrugInfoAssn #DIA2017 Kicking off at 1. Perspectives on risk-based monitoring and TQM. https://t.co/mH6Npg0kD4
bioclinica (Yesterday)
RT @Xtalks: How Improving Site Payments Can Make You the Sponsor/CRO of Choice Tune in for this live webinar with @bioclinica https://t.co/…
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