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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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Is Your Clinical Trial Payments System Scalable?

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  • 25 Aug

At Bioclinica, we often talk with CROs who have outgrown their site payment systems. Whether they're using spreadsheets or a manual, homegrown system, as the number of trials they're conducting increases, CROs often find that their current systems can't keep up.

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Elizabeth Thiele

Patient Recruitment and Retention for Healthier Studies

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  • 18 Aug

Finding patients to participate in clinical trials and keeping them engaged for the duration are two of the greatest challenges in the clinical development process. Yet, as our President and CEO John Hubbard sees it, "Every major challenge is also an opportunity to improve the clinical development process." To overcome such hurdles, we as an industry must become more efficient in conducting clinical trials while simultaneously keeping a keen focus on the patient.

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Questions to Help You Automate the Financial Lifecycle of Your Global Clinical Trials

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  • 18 Aug

During my years in the healthcare industry working closely with CROs and sponsors, I've seen many organizations realize the benefits of switching from manual payment processes like Excel spreadsheets, which are time- and resource-intensive as well as error-prone, to automated payment solutions.

I continue to receive questions regarding our software and automating the financial lifecycle of global clinical trials. I'd like to address some key questions in this blog post so that everyone can benefit from the feedback.

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Risk-Based Monitoring Cost Savings: The Icing on the Cake Not the Cake Itself

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  • 16 Aug

Reducing monitoring costs continues to be the primary driver to adopting risk-based monitoring (RBM). But should that be the leading metric?

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Stronger Through Collaboration: A new wave of eHealth Solutions

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  • 15 Aug

Learning about new technologies and thinking strategically about their application in life sciences to ultimately benefit patients is what motivates me. This makes my role at Bioclinica a perfect fit as I get to partner with developers of innovative patient-centered applications from around the world for our eHealth App xChange.

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Bioclinica's Research Network Goes Global with Compass Acquisition

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  • 12 Aug

Bioclinica's extensive Research Network of full-service clinical study sites – already located in Asia, Europe, and Latin America – achieved a global status with the recent acquisition of Compass Research. As reviewed in the CenterWatch Weekly publication, the acquisition will expand Bioclinica's Research Network into the U.S., providing a true global site network for pharmaceutical companies engaged in clinical research.

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How Do You Get People to Join Clinical Trials? Show a Movie!

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  • 10 Aug

Many people don't understand what a clinical trial is or how one is conducted. This can make it hard to recruit and screen the hundreds and often thousands of patients necessary to find qualified individuals to participate in a given study.

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End-to-End Patient Engagement Is a Reality

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  • 09 Aug

Patient engagement is an ongoing challenge when conducting clinical trials. A recent article published in CenterWatch Weekly noted, "Experts point to problems with awareness, understanding, and trust among potential trial participants as well as providers that persists today. They also cite the disconnect between a patient's interest in participating in a trial and actually taking the next step to enroll.

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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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Biomarkers and Personalized Medicine: Essential Tools

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  • 28 Mar

The use of biomarkers is expanding across all stages in the drug development process, helping bring about new and innovative practices in the treatment of many diseases, including Alzheimer's and cancer. With their ability to revolutionize development of advanced therapeutics, biomarkers have become essential tools.

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Successful Direct-to-Patient Shipping of Study Drugs

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  • 27 Mar

Clinical trials for patients with rare, debilitating diseases who have limited mobility and greater caregiving requirements can be challenging, particularly for clinic visits and medication adherence. But, we like a challenge. In a recent clinical trial, we collaborated with the sponsor to successfully ship the study drugs directly from the depot to a sample of US-based patients with a rare, progressive debilitating disease characterized by motor, cognitive and behavioral symptoms.

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Meet the Bioclinica Financial Lifecycle Solutions Team: Bob Gabriel, Senior Vice President and General Manager, Bioclinica FLS

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  • 17 Mar

Bob Gabriel is the Senior Vice President and General Manager of Bioclinica's Financial Lifecycle Solutions (FLS) division. The FLS suite of financial lifecycle products assists with managing the global automation and financial management of clinical trials and includes ClinPay, a proprietary transaction engine and secure online clinical trial payment network; ClinPlan, a budget management and cash forecasting solution; and ClinDebit, a patient reimbursement solution.

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Pathway to Quality Cardiovascular Imaging Trials

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  • 13 Mar

Cardiovascular diseases are the leading cause of death in the world and as such, the cause, prevention and treatment of all cardiovascular disease remains a very active field in the research community. Cardiovascular Imaging is a primary therapeutic service area for Bioclinica, offering comprehensive centralized medical imaging services and support for the majority of all cardiovascular imaging (CVI) modalities leveraged to provide critical endpoint assessments in clinical research.

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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
bioclinica (Yesterday)
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/…
bioclinica (Yesterday)

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